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To evaluate the effects of virtual operating room tours on perioperative anxiety in adult patients.
Design
This study was a systematic review of randomized controlled trials (RCTs).
Methods
PubMed, Cochrane Library, Embase, Web of Science, Proquest, Scopus, SinoMed, CNKI, and WanFang were systematically searched for English and Chinese RCTs published up to November 18, 2021, for studies on the effectiveness of virtual operating room tours in reducing perioperative anxiety in adult patients (>18 years of age). Primary and secondary outcomes were perioperative anxiety levels and understanding level of perioperative information and patient satisfaction, respectively. The data were synthesized using a qualitative method.
Findings
Five studies were found eligible for inclusion; 3 studies showed a significant decrease in perioperative anxiety levels in patients of the virtual operating room tours group. Furthermore, the overall satisfaction, understanding of perioperative information, and preoperative preparedness were significantly enhanced respectively in 3 studies.
Conclusions
This study showed the effectiveness of virtual operating room tour on alleviating perioperative anxiety on adult patients. Furthermore, the satisfaction and understanding of perioperative information in intervention group improved owing to these tours. Future quantitative studies are needed to support these findings.
An estimated 25% and 80% of patients admitted to hospitals for surgery experience preoperative anxiety. Anxiety levels reach the peak when patients leave the ward for the operating room.
confirmed that many studies supported the provision of operation-related information to patients before surgery as effective in lessening anxiety. Zhou et al
performed a qualitative study to understand the information-related requirements for patients with scheduled surgery during the preoperative period. They showed that most patients were perceptive on operating room information and believed that it could help reduce the anxiety.
The strict management of the operating room makes it difficult for people to visit. The education forms of operating room, equipment in the operating room or the surgical procedure are often provided by verbal or written leaflet with a brief description. Moreover, fear of the unknown is the one of the causes of preoperative anxiety. Therefore, to find a realistic method by which we could offer patients the opportunity of experiencing situations and procedures in the perioperative period will be helpful in diminishing preoperative anxiety.
Virtual reality (VR) is a state-of-the-art, technologically advanced system that allows users to be transported to a “virtual world.” This true to life interaction between users and the simulated environment allows complete immersion.
Recently, the application of VR technology has expanded from the entertainment industry to clinical medicine, such as in pain management, surgical training, and physical rehabilitation.
A meta-analysis and systematic review comparing the effectiveness of traditional and virtual surgical planning for orthognathic surgery: based on randomized clinical trials.
The virtual operating room tour (VORT) is one of such method that allows simulation of pre- and postoperative settings. Here, patients watch a video recorded by the medical team to experience a 360° virtual tour of the operating room. The video usually comprises an introduction to surgical procedures and perioperative nursing. Morgan et al
allowed 64 adults a VORT before elective cardiac catheterization, which resulted in lower perioperative anxiety, better procedural understanding, and higher overall satisfaction. At present, data on clinical utility of VORT are very limited and inconsistent. Whether such an immersion is efficient in reducing preoperative anxiety is unclear.
This systematic review aimed to explore the effectiveness of the nursing staff's use of VORT during the preoperative period to alleviate perioperative anxiety.
Methods
Protocol and Registration
This review was conducted according to the Cochrane Handbook for Systematic Review,
Higgins J, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions Version 6.3 (Updated February 2022). Cochrane; 2022. Accessed March 15, 2022. www.training.cochrane.org/handbook.
and the results were reported following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) checklist. Although we did not publish a protocol for this review, the study was registered in the PROSPERO register (number: CRD42021292862).
Search Strategy
Two authors independently searched the MEDLINE (through PubMed), Cochrane Controlled Register of Trials (CENTRAL), Embase, SCOPUS, Proquest, Web of Science, China National Knowledge Infrastructure, WanFang, and SinoMed databases from November 2021 to December 2021 using combinations of Medical Subject Headings and free text terms. Additional studies were manually acquired from the references of retrieved articles. The key search terms included “perioperative,” “preoperative,” “postoperative,” “virtual reality,” “VR,” “anxiety”. At the same time, We used Boolean search terms “not” and wildcard characters “*” to exclude child* and pediatric. The search strategy is presented in Appendix 1.
Eligibility Criteria
We established the study problems and screened articles using the PICOS frame (type of participants, intervention, comparison, primary and secondary outcomes, and study design).The studies were selected according to the inclusion and exclusion criteria of PICOS elements. The inclusion criteria were as follows:
-
Population: age greater than or equal to 18 years and underwent elective surgery
-
Intervention: VORT or a 3D virtual operating room environment facility provided in the preoperative period
-
Comparison: perioperative care
-
Outcomes: preoperative anxiety measured using anxiety assessment scales as the primary outcome, with secondary outcomes as patient understanding of perioperative information and overall satisfaction determined using any kind of questionnaires
-
Study design: randomized controlled trials (RCTs)
The exclusion criteria were as follows:
-
Surgeries performed outside the operating room (eg, dental surgery)
-
Receiving anxiolytic premedication or diagnosed with certain cognitive impairments (eg, psychiatric and autism spectrum disorder)
-
Unable to tolerate VR interventions and experienced dizziness or felt sick when using the VR
-
VR used in rehabilitation exercise for patients or VR intervention implemented by the surgeon
Specifically, the inclusion and exclusion criteria for selecting articles were as follows:
-
Articles in either English or Chinese language were included.
-
Gray literature (such as unpublished internal materials like symposium papers and conference minutes), reviews, comments, case reports, and meta-analyses were excluded.
-
Studies with incomplete data even after attempting to contact the authors, duplicates of the included trials, and unavailability of full text were excluded.
Study Selection
Articles were downloaded to a reference management program (Zotero). Two authors independently reviewed articles considering the inclusion and exclusion criteria. Full text of the articles was downloaded and color-tagged in Zotero if they were for inclusion. if they were excluded, each author tagged the reasons. Disagreements on article inclusion matters were resolved with input from a third author.
Data Extraction
Two researchers independently extracted the data and recorded them on a standard data extraction form from the Cochrane Effective Practice and Organization of Care. If insufficient information was available, the authors of eligible articles were contacted via email. The information recorded included that on author(s), publication year, publication journal, study design, objectives and outcomes, settings, participants, assessment and intervention tools, and main findings.
Risk of Bias
Risk of bias was assessed by 2 independent researchers using version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2).
Higgins J, Savović J, Page M, Elbers R, Sterne J. Chapter 8: Assessing risk of bias in a randomized trial. In: Higgins JPT, Thomas J, Chandler J, eds, et al.. Cochrane Handbook for Systematic Reviews of Interventions Version 6.3 (Updated February 2022). Cochrane; 2022. Accessed January 1, 2022. www.training.cochrane.org/handbook.
The tool covers 5 domains of bias arising from the following: (1) randomization process, (2) deviations from intended interventions, (3) missing outcome data, (4) measurement of the outcome, and (5) selection of the reported result. Before the assessment, the authors indicated the specific results extracted from the assessed trails. Considering that the nursing system would recommend VORT as a perioperative education tool, we included intention-to-treat effects. If there were disagreements regarding assessment outcomes between the 2 authors, a discrepancy check was conducted, and these differences were resolved through discussion with a third author.
Synthesis of Results
Sample size, anxiety scores, and type of surgery were different in each included study, hence, the heterogeneity among included studies was high. A qualitative method was used to synthesize the literature.
Results
Study Selection
A total of 1,727 articles were identified through the database search, while 3 were identified manually: 565 were duplicates and 1,090 were excluded considering their titles and abstracts. Full text of the remaining 75 were examined, and 70 were excluded owing to (1) unavailability of full-length articles (n = 7);(2) intervention (n = 23), outcomes (n = 26), and patient criteria (n = 11); (3) inability to contact corresponding authors for details (n = 1); and (4) study designs aside from RCTs (n = 2). Ultimately, 5 studies were included. in this systematic review.
Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.
Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.
Aim: To investigate whether a virtual operating room tour (VORT) before surgery can be used to ameliorate perioperative anxiety. Primary outcomes: Anxiety Secondary outcomes: Evaluation of VORT
The Clinic for Anesthesiology, RWTH Aachen University Hospital, Germany September 2020 to January 2021
84
T:54.19±15.94
elective surgery with general anesthesia (except for thoracic surgery, neurosurgery, and tumor surgery)
Before the surgery
Watching a 6 minutes 28 seconds virtual tour of the operation room
No virtual tour of the operation room
Anxiety: the State-Trait Operation Anxiety Inventory (STOA) in which Trait anxiety(STOA-T) was measured at T2 (before operation) and State anxiety(STOA-S) was measured at T1 and T3(within 48 hours after operation) Evaluation of VORT: an in-house designed questionnaire
For the anxiety level, there were no significant differences at T2 and T3 between 2 groups
Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.
Aim: To evaluate the effectiveness of exposure to the entire perioperative environment through virtual reality in decreasing the preoperative anxiety Primary outcomes: Anxiety
Third-level Academic Center in Barcelona, Spain April 2018 to February 2020
126
E: 68 C: 64
Elective colorectal surgery
After patients were recruited and before the surgery
Exposure to a realistic perioperative period environment
No virtual reality exposure
Anxiety: the State-Trait Anxiety Inventory Scale State (STAI-S) and the Hospital Anxiety and Depression Scale (HADS) were measured at T1 (after randomization and before intervention) and T2 (before surgery, only for intervention group)
For both the HADS and STAI-S the observed values were significantly decreased in intervention group for the change of T1 to T2 (HAD-A: difference, -1.00; P < .001, STAI-S: difference, -6.00; P < .01)
Aim: to evaluate the use of an immersive VR experience on periprocedural anxiety, compared with using generic video-based material before an elective cardiac catheterization. Primary outcomes: periprocedural anxiety level Secondary outcomes: patients knowledge of their procedure and overall satisfaction.
The tertiary center of University Hospital of Wales, Cardiff, United Kingdom August 2019 to February 2020
64
T:68.7±9.8
Cardiac Catheterization
After patients were recruited and before the surgery
Watching a 10-minute VR immersive video on a dedicated VR headset which describes the procedural experience except for receiving an information booklets and verbal explanation (n = 33)
Receiving the standard preprocedural care (BHF information booklets, verbal explanation of the procedure and watch the BEIF cardiac catheterization video) (n = 31)
Anxiety: the 6-item short form of the State Trait Anxiety Inventory (STAI) at T1 (after informed consent), T2 (Preprocedure) and T3 (Postprocedure) Patients knowledge of their procedure: a patient-reported knowledge score at T1, T2 and T3 Overall satisfaction: a patient-reported statements
For the anxiety level, a significant lower than control group at T3(8.5 vs 9.7, respectively; P = .48), and the change from T1 to T3 (-5.1 vs -4.0, respectively; P = .03) The VR group had a better procedural understanding (3.88 vs 3.23, respectively; P < .01) and higher overall satisfaction than the control group (9.35 vs 8.97, respectively; P = .04)
Aim: to determine whether a VR video in addition to standard preoperative information decreases anxiety levels before a planned cesarean delivery (CD) . Primary outcomes: a change on the Visual Analogue Scale for Anxiety (∆VAS-A) measured at admission for CD secondary outcomes: the symptoms of motion sickness when experienced CR video (both for CD and partner), distress and the postoperative quality of care((for all participants)
Máxima Medical Center in Veldhoven, the Netherlands November 2016 to January 2018
97
E: 32.6±3.9 C: 33.12±4.3
Cesarean Delivery
After patients were recruited and before the surgery
Watching an 285 seconds 360° VR video which shows a procedure of cesarean delivery through Infor-Med app and VR glasses except for receiving the standard information (n = 49)
Receiving the standard information from their doctor through information leaflets and oral counseling (n = 48)
Anxiety: the Visual Analogue Scale for Anxiety (VAS-A) at T1 (after informed consent) and T2 (admission to the ward) Motion sickness: The Simulation Sickness Questionnaire (SSQ) at T1 (for VR group) Distress: The Tilburg Pregnancy Distress Scale(TPDS) at T1, T2 and T3 (1-2 weeks after CD) and The Childbirth Perception Scale (CPS) at T3 Quality of care: the Pregnancy and Childbirth Questionnaire (PCQ) at T3
For the anxiety level, there is no significant difference at T1 and T2 between 2 groups (n = 48; ΔVAS-A = 1.0; P = .08; 95% CI −0.1 to 2.0). No discomfort or motion sickness during VR experience. No significant difference in TPDS. For the PCQ questionnaire, a significantly higher score for the VR group without a history of emergency CD (10.2±3.8 vs 12.9±3.5; P = .02)
Aim: To investigate the effect of exposure to a VR environment preoperatively on patient-reported outcomes for surgical operations. Primary outcomes: experience and satisfaction, preoperative anxiety Secondary outcomes: pain, stress and preparedness
Dartmouth-Hitchcock Medical Center, Lebanon, NH, America November 2015 to April 2016
127
T:55.3
Cranial and spinal procedures
Before the surgery
Watching a 5-minute VR video describing the preoperative and postoperative experience for the day of the surgery (n = 64)
Receiving the routine audiovisual descriptions of the preoperative experience(n = 63)
Anxiety: the Amsterdam Preoperative Anxiety and Information score (APAIS) at T2 (preoperatively on the day of the surgery) Satisfaction: the Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) score at T3 (postprocedure) and visual analog scales of satisfaction at T2 and T3 Pain: visual analog scales of pain at T2, T3 and 30-days postoperatively were only obtained for spine patients Stress: Visual analog scales of stress at T2 Preparedness: Visual analog scales of preparedness at T2
For the anxiety level, a significant lower than control group at T2 (difference, 29.9; 95% CI, 24.5-35.2; P < .01) VR led to lower preoperative VAS stress score (difference, -41.7; 95% CI, -33.1 to -50.2; P < .01), and higher preoperative VAS preparedness (difference, 32.4; 95% CI, 24.9-39.8; P < .01), and VAS satisfaction (difference, 33.2; 95% CI, 25.4-41.0; P < .01) scores. No association was identified with VAS pain score at T2, T3 and 30-days postoperatively
Participants in the control group were supplied standard information via traditional means. In contrast, those in the VORT group watched an immersive video that described the surgical set-up they will be facing, including preoperative preparation, a view of the operating room, and postoperative anesthesia resuscitation using VR glasses/headsets.
Included studies used different tools to measure anxiety. These included the State-Trait Operation Anxiety Inventory, Hospital Anxiety and Depression Scale, Visual Analog Scale for Anxiety (VAS-A), a 6-item short form of the State Trait Anxiety Inventory (6-item STAI), and the Amsterdam Preoperative Anxiety and Information Scale. A high score corresponded to a high level of anxiety in 4 studies,
Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.
A total of 498 participants were included in this study. The surgeries they underwent ranged from colorectal surgery, cesarean delivery, and cardiac catheterization to cranial and spinal surgery.
Risk of Bias Assessment
Figure 2 shows the risk of bias results. The overall bias for one study was low,
while the other 3 showed concerns due to unclear concealed allocation sequences (study 2) and unclear random sequence generation (study 1 and study 4).
Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.
All 5 studies used different tools to measure perioperative anxiety (Table 2). Studies 1, 3, and 4 showed no significant difference in preoperative anxiety scores between the VORT and control groups.
Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.
In study 2, the authors did not measure the preoperative anxiety score in the control group, whose study showed a significant decrease on anxiety score only by using a self-control within the intervention group.
Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.
APAIS, Amsterdam Preoperative Anxiety and Information Scale; HADS, hospital anxiety and depression scale; STAI, state trait anxiety scale; STOA-S, state-trait operation anxiety inventory, VAS-A, visual analog scale for anxiety.
As elderly patients may exhibit possible individual differences in adapting to new technology, study 2 analyzed preoperative anxiety according to age (≤65 years vs >65 years) and found no significant differences in perceived anxiety levels in patients who either received a virtual tour.
Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.
Additionally, study 3 found that for women with a history of cesarean delivery, VR was more effective in easing anxiety, although this was not significant (P = .06).
Study 4 reported that the VORT group better understood the surgical procedure than the control group (perioperative knowledge scores 3.88 vs 3.23, respectively; P < .01).
For this reason, in study 1, participants perceived VORT as a useful tool for preparation for surgery (median rating 4 in a 1- to 5-grade questionnaire).
This systematic review evaluated the effectiveness of VORTs in reducing perioperative anxiety in adult patients. Although included studies showed a lack of homogeneity in terms of the patients, sex, surgery types, and tools used to measure anxiety, VORT application showed a propensity to allay perioperative anxiety. VORT offers participants a chance to learn more about the surgical department's appearance and perioperative details. VORT was a significant factor in increasing patient satisfaction and improving their understanding of perioperative information.
Participants showed a positive response to VORT. Only a singular adverse effect was reported: one patient experienced transient dizziness within seconds of starting the viewing but was still able to complete the tour.
Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.
Most participants found the VORT experience pleasant and were willing to recommend it. This supports the possible clinical application of VORT in a surgical setting.
Preoperative visits have been shown to reduce anxiety.
The effect of multimedia-based nursing visit on preoperative anxiety and vital signs in patients undergoing lumbar disc herniation surgery: a randomised clinical trial.
Patients can access VORT repeatedly using VR glasses and applications on their mobile phones. Thus, VORT can be considered a convenient way to provide perioperative information to reduce anxiety levels concerning surgery.
Better understanding of perioperative information is linked to better preoperative preparedness, which lessens cancellations and delay of elective surgeries.
Such efficient education format is especially fit for high-speed operation setting such as day surgery. Further studies should explore VORT's effectiveness in day surgery or outpatient surgery, where patient education is seriously restricted by time owing to the rapid patient turnover.
Notably, perioperative anxiety scores did not differ significantly between the 2 groups in studies 1, 3, and 4.
This may be, in part, because all these 3 studies included participants who have history of surgery in eligibility criteria. According to previous studies, patients with no prior surgeries may be at greater risk of preoperative anxiety.
This may have led to biases in the included studies, contributing to unnoticeable changes between the VORT group and control groups.
The RCTs analyzed included women undergoing cesarean delivery. Many women experience moderate or severe anxiety, depression, and fear as baseline emotions during pregnancy.
More studies are required to explore preoperative information requirements of pregnant women who are going to undergo cesarean delivery.
When providing information, need-based patient education should be followed. According to this concept, patients’ desire to be educated regarding their elective surgery should be assessed before providing information. According to a previous study,
patients with an avoidant coping style who desire only minimal amount on their surgery may become more anxious owing to VORT. In short, patient education via VORT should be tailored accordingly.
Limitations
This review has some limitations. First, we could not perform a quantitative synthesis because each study's reported anxiety scores and surgical populations were different. Second, the included studies in the systematic review are outdated. Owing to the limited number of studies, the effectiveness of VORT was demonstrated only in 3 studies. Finally, only studies published in English and Chinese language were included.
Conclusion
This systematic review showed VORT as a promising tool in alleviating perioperative anxiety in adult patients. The intervention groups reported greater satisfaction, better understanding of perioperative information, and better preoperative preparation. The results are consistent with findings that multiple modes of education delivery help reduce perioperative anxiety.
While, the educational content and details are not completely consistent for different patients, further quantitative studies that can personalize VORT experiences may be needed to support the conclusions of this study.
Appendix 1
Appendix 1Search Strategy
Search strategy
Data base
Search strategy
Number
PubMed (Mesh)
((virtual reality[MeSH Terms])) AND ((((((nursing, operating room[MeSH Terms])) OR ((period, perioperative[MeSH Terms]))) OR ((period, preoperative[MeSH Terms]))) OR ((care, postoperative[MeSH Terms]))))
33
PubMed (Freedom)
(((((((((perioperative[Title/Abstract]) OR (preoperative[Title/Abstract])) OR (postoperative[Title/Abstract])) OR (operati*[Title/Abstract]))) AND (((virtual reality*[Title/Abstract]) OR (VR[Title/Abstract]))))) NOT (((child*[Title/Abstract]) OR (Pediatric[Title/Abstract]))))) AND (((RCT[Title/Abstract]) OR (randomized controlled trial[Title/Abstract])OR (randomized clinical trial[Title/Abstract])))
67
Cochrane (Mesh)
#1 MeSH descriptor: [Perioperative Period] explode all trees
5
#2 MeSH descriptor: [Preoperative Period] explode all trees
#3 MeSH descriptor: [Postoperative Period] explode all trees
#4 MeSH descriptor: [Virtual Reality] explode all trees
#5 MeSH descriptor: [Randomized Controlled Trial] explode all trees
#6 MeSH descriptor: [Child] explode all trees
#7 #1 OR #2 OR #3
#8 #7 AND #4
#9 #8 NOT #6
Cochrane (Freedom)
#1 (perioperative):ti,ab,kw
302
#2 (preoperative):ti,ab,kw
#3 (postoperative):ti,ab,kw
#4 (operati*):ti,ab,kw
#5 (virtual reality*):ti,ab,kw
#6 (VR):ti,ab,kw
#7 #1 OR #2 OR #3 OR #4
#8 #5 OR #6
#9 #7 AND #8
#10 (child*):ti,ab,kw
#11 (pediatric):ti,ab,kw
#12 #10 OR #11
#13 #9 NOT #12
#14 (randomized controlled trial OR randomized clinical trial OR RCT):ti,ab,kw
#15 #14 AND #13
Embase
#15. #14 AND #13
285
#14. 'randomized controlled trial':ti,ab,kw OR 'randomized clinical trial':ti,ab,kw OR rct:ti,ab,kw
#13. #9 NOT #12
#12. #10OR #11
#11. pediatric:ab,kw,ti
#10. child*:ab,kw,ti
#9. #4 AND #8
#8. #6 OR #7
#7. vr*:ab,kw,ti
#6. virtual AND reality*:ab,kw,ti
#5. #1 OR #2 OR #23 OR #4
#4. operati*:kw,ab,ti
#3. postoperative:kw,ab,ti
#2. preoperative:kw,ab,ti
#1. perioperative:kw,ab,ti
Web of Science
#1 (((TS=(preoperative)) OR TS=(perioperative)) OR TS=(postoperative)) OR TS=(operati*)
323
#2 (TS=(virtual reality*)) OR TS=(VR)
#3 (#1) AND #2
#4 (TS=(child*)) OR TS=(pediatric)
#5 (#3) NOT #4
#6 (TS=(RCT)) OR TS=(randomized controlled trial) OR TS=(randomized clinical trial)
#7 (#5) AND #6
Proquest
((su(Randomized controlled trial) OR su(Randomized clinical trial) OR su(RCT)) AND (su(Virtual Reality*) OR su(VR)) AND (su(Perioperative) OR su(Preoperative) OR su(Postoperative) OR su(operati*))) NOT (su(child) OR su(pediatric))
4
Scopus
((TITLE-ABS-KEY (perioperative*) OR TITLE-ABS-KEY (preoperative) OR TITLE-ABS-KEY (postoperative) OR TITLE-ABS-KEY (operati*))) AND (TITLE-ABS-KEY (virtual AND reality) OR TITLE-ABS-KEY (vr)) AND (TITLE-ABS-KEY (randomized AND controlled AND trial) OR TITLE-ABS-KEY (randomized AND clinical AND trial) OR TITLE-ABS-KEY (rct)) AND NOT (ALL (child*) OR ALL (pediatric))
258
Sinomed
(((((((围术期 OR 术前 OR 术中 OR 术后)) AND ((虚拟现实 OR 虚拟现实技术 OR 增强现实 OR 增强现实技术)))) AND (护理))) NOT ((儿童 OR 患儿 OR 小儿)))
143
CNKI
(((((((围术期 OR 术前 OR 术中 OR 术后)) AND ((虚拟现实 OR 虚拟现实技术 OR 增强现实 OR 增强现实技术)))) AND (护理)))
30
Wanfang
((主题:(围术期) or 主题:(术前) or 主题:(术中) or 主题:(术后) ) AND (主题:(虚拟现实) or 主题:(虚拟现实技术) or 主题:(增强现实) or 主题:(增强现实技术) or 主题:(VR)) AND 主题:(护理)) NOT (全部:(患儿) or 全部:(儿童) or 全部:(早产儿))
assignment to intervention (the ‘intention-to-treat' effect)
Experimental
VORT
Comparator
standard operation preparation procedure
Source
Outcome
Preoperative anxiety
Results
Weight
1
Bias arising from the randomization process
1.1 Was the allocation sequence random?
Y
Participants were randomly assigned to one of the study arms (VORT vs STOPP) by a person not involved in data acquisition using the following procedure: for all patients (N = 80), we created opaque assignment envelopes containing a folded paper with a study arm assignment (VORT or STOPP), with a total of 40 participants in each arm. The order of the envelopes was randomized before the beginning of the study.
1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?
Y
1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?
PY
Data from the remaining 72 patients (mean age 54.19, SD 15.94, with a range of 20 to 81 years), with 35 female and 37 male subjects, was analyzed (VORT: n = 35 vs STOPP: n = 37). Due to no characteristics of baseline shown, the level of anxiety may various due to a significant difference in population of different type of surgery.
Risk of bias judgment
Some concerns
Bias due to deviations from intended interventions
2.1.Were participants aware of their assigned intervention during the trial?
Y
Patients were informed about the study background, the study arms, and the content of the video.
2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?
Y
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?
PN
2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
NA
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
NA
2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?
PY
2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyze participants in the group to which they were randomized?
NA
Risk of bias judgment
Low
Bias due to missing outcome data
3.1 Were data for this outcome available for all, or nearly all, participants randomized?
N
In total, 84 patients were included in the study. Dropouts (n = 12; 14.3%) were in the expected range; however, since all dropouts occurred during the enrolment of the first 62 patients, we decided at this time point to create and randomize 20 additional assignment envelopes. The primary reason for dropouts was the early discharge of the patient. Other reasons included postponed or additional surgeries and postoperative complications. VORT-associated concerns or worries were not reported; therefore, VORT did not contribute to participation dropouts.
3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?
Y
3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?
NA
3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
NA
Risk of bias judgment
Low
Bias in measurement of the outcome
4.1 Was the method of measuring the outcome inappropriate?
N
both trail registration and trail only used one method (STOA) to measure outcomes
4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?
N
The interview consisted of a detailed explanation by the educating physician (anesthetist). A standardized information sheet was further used to explain the procedure and the anesthesia used, corresponding to the hospital's standard operating procedure, and it was identical for all patients in both study arms (VORT and STOPP).
4.3 Were outcome assessors aware of the intervention received by study participants?
Y
it's a participant-reported outcomes
4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
PN
Patients in anxiety will express their true anxiety level, although they may be know which intervention they have received.
4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?
NA
Risk of bias judgment
Low
Bias in selection of the reported result
5.1 Were the data that produced this result analyzed in accordance with a prespecified analysis plan that was finalized before unblinded outcome data were available for analysis?
Y
through examination of a trail protocol, the way to measure outcome is same
5.2 ... multiple eligible outcome measurements (eg, scales, definitions, time points) within the outcome domain?
N
through examination of a trail protocol, only STOA used to measure outcome
5.3 ... multiple eligible analyses of the data?
N
outcomes report contain 1 tool and 2 time point as the same as the trail protocol
Risk of bias judgment
Low
Overall bias
Risk of bias judgment
Some concerns
due to the nature of the intervention
Unique ID
Turrado 2021
Study ID
NCT04058600
Assessor
yu
Ref or Label
Aim
assignment to intervention (the 'intention-to-treat' effect)
Experimental
VR video
Comparator
no VR
Source
Outcome
STAI anxiety level
Results
Weight
1
Bias arising from the randomization process
1.1 Was the allocation sequence random?
Y
Patients were randomized using en bloc randomization with random block sizes.
1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?
NI
1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?
N
There were no differences in terms of age or sex distribution between both groups, or in the surgeries performed in both groups. Median hospital stay was 3.1 days (95% CI 2.3–4.8 days), with no differences between groups: 3.2 days (95% CI 2.2–4.7 days) in the no-VR group and 3.1 (95% CI 2.4–4.9 days) in the VR group.
Risk of bias judgment
Some concerns
Bias due to deviations from intended interventions
2.1.Were participants aware of their assigned intervention during the trial?
Y
If interested, an interview was scheduled in which they signed the informed consent and were randomized into the control group (no Virtual Reality exposure) or the intervention group (Virtual Reality exposure). Patients were randomized using en bloc randomization with random block sizes.
2.2. Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?
Y
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?
PN
No adverse effects were noted and no subjective assessments of the experience by patients were reported. Only one of the patients exposed to the virtual reality simulation experienced a transient dizzy sensation within seconds of starting the viewing, but was able to complete it successfully.
2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
NA
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
NA
2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?
Y
No adverse effects were noted and no subjective assessments of the experience by patients were reported. Only one of the patients exposed to the virtual reality simulation experienced a transient dizzy sensation within seconds of starting the viewing, but was able to complete it successfully.
2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyze participants in the group to which they were randomized?
NA
Risk of bias judgment
Low
Bias due to missing outcome data
3.1 Were data for this outcome available for all, or nearly all, participants randomized?
Y
No adverse effects were noted and no subjective assessments of the experience by patients were reported. Only one of the patients exposed to the virtual reality simulation experienced a transient dizzy sensation within seconds of starting the viewing, but was able to complete it successfully.
3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?
NA
3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?
NA
3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
NA
Risk of bias judgment
Low
Bias in measurement of the outcome
4.1 Was the method of measuring the outcome inappropriate?
Y
Patients in control group only completed baseline questionnaires, this limitation is also mentioned in the last of the article.
4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?
PN
4.3 Were outcome assessors aware of the intervention received by study participants?
NA
4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
NA
4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?
NA
Risk of bias judgment
Low
Bias in selection of the reported result
5.1 Were the data that produced this result analyzed in accordance with a prespecified analysis plan that was finalized before unblinded outcome data were available for analysis?
Y
through examination of a trail protocol, the way to measure outcome is same
5.2 ... multiple eligible outcome measurements (eg, scales, definitions, time points) within the outcome domain?
N
through examination of a trail protocol, the way to measure outcome is same
5.3 ... multiple eligible analyses of the data?
N
outcomes report contain 1 tool and 2 time point as the same as the trail protocol
Risk of bias judgment
Low
Overall bias
Risk of bias judgment
Some concerns
Unique ID
Morgan 2021
Study ID
NCT03957538
Assessor
yu
Ref or Label
Aim
assignment to intervention (the ‘intention-to-treat' effect)
Experimental
VR experiences
Comparator
standard procedural care
Source
Outcome
anxiety (6-item STAI)
Results
Weight
1
Bias arising from the randomization process
1.1 Was the allocation sequence random?
NI
patients were then randomized to standard preprocedural care or preprocedural care with immersive VR experience(but there were no detail about sequence generation process and allocation sequence concealed)
1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?
NI
1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?
N
Risk of bias judgment
Some concerns
Bias due to deviations from intended interventions
2.1.Were participants aware of their assigned intervention during the trial?
PY
due to the nature of this intervention
2.2. Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?
Y
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?
PN
2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
NA
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
NA
2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?
PY
due to the COVID-19 the trail terminated prematurely
2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyze participants in the group to which they were randomized?
NA
Risk of bias judgment
Low
Bias due to missing outcome data
3.1 Were data for this outcome available for all, or nearly all, participants randomized?
N
There were 87 patients recruited into the trial between August 2019 and February 2020. The trial was terminated prematurely due to service changes related to the COVID-19 pandemic. In total, 64 patients completed the trail protocol and were included in the analysis. Of these, 33 were randomized to the VR arm, and 31 to the control arm.
3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?
N
3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?
PN
due to the pandemic
3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
NA
Risk of bias judgment
Low
Bias in measurement of the outcome
4.1 Was the method of measuring the outcome inappropriate?
N
The primary outcome measure was periprocedural anxiety level. Data collection was via questionnaire based on the validated 6-item short form of the State Trait Anxiety Inventory (STAI), a well-established and validated measure of anxiety.
4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?
N
Preprocedural (Appendix 1B) and postprocedural anxiety questionnaires (Appendix IC), as well as a satisfaction questionnaire (Appendix ID) were then completed when the patient attended their procedure.
4.3 Were outcome assessors aware of the intervention received by study participants?
Y
it's a participant-reported outcomes
4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
PN
Patients in anxiety will express their true anxiety level, although they may be know which intervention they have received.
4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?
NA
Risk of bias judgment
Low
Bias in selection of the reported result
5.1 Were the data that produced this result analyzed in accordance with a prespecified analysis plan that was finalized before unblinded outcome data were available for analysis?
Y
through examination of a trail protocol, the way to measure outcome is same
5.2 ... multiple eligible outcome measurements (eg, scales, definitions, time points) within the outcome domain?
N
through examination of a trail protocol, the way to measure outcome is same
5.3 ... multiple eligible analyses of the data?
N
outcomes report contain1 tool and 3 time point as the same as the trail protocol
Risk of bias judgment
Low
Overall bias
Risk of bias judgment
Some concerns
Unique ID
Noben 2019
Study ID
ISRCTN74794447
Assessor
yu
Ref or Label
Aim
assignment to intervention (the 'intention-to-treat' effect)
Experimental
VR video
Comparator
standard preoperative information
Source
Outcome
anxiety (VAS-A)
Results
Weight
1
Bias arising from the randomization process
1.1 Was the allocation sequence random?
Y
Randomization was performed by the researcher (LN) using a Web-based computer randomizer generating a randomization list. Couples were randomized into 2 groups by means of stratified block randomization
1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?
NI
1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?
N
There were no differences between the groups with respect to age, gestational age at delivery, parity, and the incidence noticed a significant difference in the level of education, with a higher proportion of participants with a high level of education level in the control group (P = .03). while a linear regression analysis was used to test the influence of VR
Risk of bias judgment
Some concerns
Bias due to deviations from intended interventions
2.1.Were participants aware of their assigned intervention during the trial?
PN
They were not explicitly informed that the study involved a VR video but were told that the intervention group received a novel method of information provision in addition to the standard information. Masking of the researcher and participants was not possible because of the nature of the intervention.
2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?
Y
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?
NI
2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
NA
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
NA
2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?
PN
high number of missing data, we decided continuing included participants until we reached 80 completed questionnaire, while there is no detail why missing date was happen
2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyze participants in the group to which they were randomized?
NI
Risk of bias judgment
High
Bias due to missing outcome data
3.1 Were data for this outcome available for all, or nearly all, participants randomized?
PN
Owing to the high number of missing questionnaires at the start of the study, we decided to continue including patients until we reached 80 completed questionnaires at time point 2, which included our primary outcome measure.
3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?
PN
the author did not suggest the reason of missing data
3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?
PN
3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
NA
Risk of bias judgment
Low
Bias in measurement of the outcome
4.1 Was the method of measuring the outcome inappropriate?
N
The VAS-A was used in the first and second questionnaires to measure preoperative anxiety
4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?
N
both intervention group and control group used a VAS_A to measure outcomes
4.3 Were outcome assessors aware of the intervention received by study participants?
Y
it's a participant-reported outcomes
4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
PN
Patients in anxiety will express their true anxiety level, although they may be know which intervention they have received.
4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?
NA
Risk of bias judgment
Low
Bias in selection of the reported result
5.1 Were the data that produced this result analyzed in accordance with a prespecified analysis plan that was finalized before unblinded outcome data were available for analysis?
Y
through examination of a trail protocol, the way to measure outcome is same
5.2 ... multiple eligible outcome measurements (eg, scales, definitions, time points) within the outcome domain?
N
through examination of a trail protocol, the way to measure outcome is same
5.3 ... multiple eligible analyzes of the data?
N
outcomes report contain1 tool and 2 time point as the same as the trail protocol
Risk of bias judgment
Low
Overall bias
Risk of bias judgment
High
Unique ID
Bekelis 2016
Study ID
NCT02619708
Assessor
yu
Ref or Label
Aim
assignment to intervention (the 'intention-to-treat' effect)
Experimental
VR experience
Comparator
standard preoperative experience
Source
Outcome
anxiety by APAIS
Results
Weight
1
Bias arising from the randomization process
1.1 Was the allocation sequence random?
Y
A block-randomization design was used with randomly permuted block sizes of 4 on the basis of a computerized random-number generator with sequentially numbered opaque, sealed envelopes for each stratum.
1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?
Y
1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?
PN
A total of 127 patients (mean age 55.3 years, 41.9% females) were randomized into this study from November 2015 to April 2016 (Figure 1). Table 1 demonstrates the distribution of patient characteristics between patients exposed to a preoperative immersive VR experience, and those undergoing a standard preoperative experience.
Risk of bias judgment
Low
Bias due to deviations from intended interventions
2.1.Were participants aware of their assigned intervention during the trial?
Y
Because of the nature of the interventions, patients and treating physicians were aware of the study-group assignments
2.2. Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?
Y
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?
PN
2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?
NA
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?
NA
2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?
Y
All analyses were based on the intention-to-treat principle,
2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyze participants in the group to which they were randomized?
NA
Risk of bias judgment
Low
Bias due to missing outcome data
3.1 Were data for this outcome available for all, or nearly all, participants randomized?
PY
each group have 11/12 patients dropout due to same reason
3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?
NA
3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?
NA
3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
NA
Risk of bias judgment
Low
Bias in measurement of the outcome
4.1 Was the method of measuring the outcome inappropriate?
N
The primary outcomes (Supplementary Methods, http://links. lww.com/SLA/B150) were the Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) score and the Amsterdam Preoperative Anxiety and Information (APAIS) score.2
4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?
N
The APAIS score [range 4 (worst) to 20 (best)] is a standardized self-reported questionnaire to evaluated preoperative patient anxiety (Supplementary Methods, http://links.lww.com/SLA/ B150).24 It consists of 6 items, which cover 3 separate anxiety domains, and was obtained preoperatively on the day of the surgery.24
4.3 Were outcome assessors aware of the intervention received by study participants?
Y
it's a participant-reported outcomes
4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
PN
Patients in anxiety will express their true anxiety level, although they may be know which intervention they have received.
4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?
NA
Risk of bias judgment
Low
Bias in selection of the reported result
5.1 Were the data that produced this result analyzed in accordance with a prespecified analysis plan that was finalized before unblinded outcome data were available for analysis?
Y
through examination of a trail protocol, the way to measure outcome is same
5.2 ... multiple eligible outcome measurements (eg, scales, definitions, time points) within the outcome domain?
N
through examination of a trail protocol, the way to measure outcome is same
5.3 ... multiple eligible analyses of the data?
N
outcomes report contain 1 tool and 2 time point as the same as the trail protocol
Risk of bias judgment
Low
Overall bias
Risk of bias judgment
Low
VR, virtual reality; VORT, virtual operating room tour; STOPP, standard operation preparation procedure; STOA, the State-Trait Operation Anxiety Inventory; STAI, the State-Trait Anxiety Inventory Scale; HADS, the Hospital Anxiety and Depression Scale; VAS-A, the Visual Analogue Scale for Anxiety; APAIS, the Amsterdam Preoperative Anxiety and Information Scores; Y/PY/NI, Yes/Probably Yes/ No information; N/PN/NI, No/Probably No/ No information.
A meta-analysis and systematic review comparing the effectiveness of traditional and virtual surgical planning for orthognathic surgery: based on randomized clinical trials.
Higgins J, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions Version 6.3 (Updated February 2022). Cochrane; 2022. Accessed March 15, 2022. www.training.cochrane.org/handbook.
Higgins J, Savović J, Page M, Elbers R, Sterne J. Chapter 8: Assessing risk of bias in a randomized trial. In: Higgins JPT, Thomas J, Chandler J, eds, et al.. Cochrane Handbook for Systematic Reviews of Interventions Version 6.3 (Updated February 2022). Cochrane; 2022. Accessed January 1, 2022. www.training.cochrane.org/handbook.
Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.
The effect of multimedia-based nursing visit on preoperative anxiety and vital signs in patients undergoing lumbar disc herniation surgery: a randomised clinical trial.
A significant difference is observed.
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