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The Effects of Designing an Educational Animation Movie in Virtual Reality on Preoperative Fear and Postoperative Pain in Pediatric Patients: A Randomized Controlled Trial
The purpose of the study was to investigate the effects of watching an educational animated movie on fear and pain in children aged 6 to 12 years old.
Design
A randomized controlled trial.
Methods
In this study, the CONSORT checklist was used as a guide. The sample of participants (n = 132) was allocated to the Educational Animation Group (n = 44), Documentary Group (n = 44), and Control Group (n = 44) using block randomization. During the data collection, an information form, the Children's Fear Scale and Wong-Baker Faces Pain Rating Scale were used.
Findings
Preoperative fear and postoperative pain scores were significantly lower in the Educational Animation group than in the other groups.
Conclusions
The educational animated movie was found to be an effective method in reducing preoperative fear and postoperative pain. Educational animated movies, which were effective in reducing the fear and pain of the child in the preparatory operations, increased the educational effectiveness and cooperation of the child.
Hospitalization and medical experiences are critical, negative experiences causing anxiety in patients. These experiences may be complex and stressful for children and their families.
Hospital environmental factors may cause stress, fear, and anxiety in children. These factors include a different environment, change in routine, different voices, lights and instruments, strangers, painful interventions, being away from family members and friends, disease symptoms such as pain and vomiting, loss of control, activity limitation, communication difficulty, dark setting, and other crying children.
Children aged between 6 and 12 years want to know the effects of the disease on their body functions. They can understand this if explained with simple language and images.
They are also willing to cooperate with healthcare personnel. If children are kept informed and involved in the decision-making processes as much as possible, their feelings of loss of control decrease, and collaborative approaches increase.
Informing children in the preoperative period is an effective method of increasing children's feelings of control in medical and surgical interventions. Information given in the preoperative period effectively decreases the pain and fear in children.
Excessive stress, fear, and pain may affect children's physical and physiological health. Children may have difficulty in coping with medical practices and show behavioral changes such as screaming, demanding, refusing, crying, and moving too much. Therefore, clinical investigators should develop, administer, and evaluate interventions such as education, therapeutic play, that improve children's ability to control or minimize their level of anxiety when undergoing hospitalization and medical intervention.
, Preoperative preparation education including preoperative and postoperative periods are examples of these interventions. A fundamental goal of nursing care is preparing children for physical, psychological, and social well-being at the best possible level.
Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a randomized controlled trial.
Video distraction and parental presence for the management of preoperative anxiety and postoperative behavioral disturbance in children: a randomized controlled trial.
found that describing preoperative procedures and operating rooms through use of toys decreases postoperative anxiety in children between the ages of 7 and 12 years. He et al
Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a randomized controlled trial.
found that describing the surgery environment through video decreases preoperative anxiety and postoperative pain in children aged between 6 and 14 years. Buyuk Tural and Bolısık
Video distraction and parental presence for the management of preoperative anxiety and postoperative behavioral disturbance in children: a randomized controlled trial.
found preoperative video distraction an effective method for reducing children's anxiety. Children aged between 6 and 12 years did not want to lose their self-control and easily cooperated, which indicated their openness to education. Using visual materials is effective in education to decrease children's preoperative fears and postoperative pains.
In these studies, various education, play, toys, or visual materials were used in the preoperative period and were effective in reducing pain and fear. An animated movie, one example of visual material, has been used in nursing studies about nursing interventions and care planning. However, no study was found that designed a preoperative education for children as an animated movie.
The primary objective of this study was to investigate the effects of watching the educational animated movie in the preoperative period on fear and postoperative pain in children who are having surgery. While achieving this goal, it was thought that the education should be specific to children (example: preparation of educational material as animation) and should attract the attention of children (example: designing an animated movie in the form of a cartoon). In line with this goal, the education was prepared as an animated movie so that the education given was specific to the child. Considering the interest of children in the 6 to 12 age group in technology, the movie was watched with virtual reality (VR) goggles.
Purpose
The purpose of the study was to investigate the effects of watching an educational animated movie on fear and pain in children aged 6 to 12 years old.
The hypotheses of this study were:
H1: : Fear scores of the children in the educational animation group will be lower than those in the documentary group and control group.
H2: : Pain scores of the children in the educational animation group will be lower than those in the documentary group and control group.
Methods
Study Design and Sample
This study was a prospective, randomized controlled trial. It was carried out between September 2017 and September 2018 at the pediatric surgery clinic of a university hospital. A parallel trial design was used describing two intervention groups (educational animation group (with VR) and documentary movie group (with VR) and a control group as the third arm. In this study, the CONSORT checklist was used by guidelines.
The study was approved by the Ege University's Institutional Review Board (IRB:17-4.1/4). The sample group of the study was selected according to the pediatric surgery clinic's planned surgery lists. The children and their parents were informed about the study. The written and verbal permissions were obtained using the “Information and Consent Form” from children and parents at the outpatient clinic the morning of the surgery by PI. The study was registered in the Clinical Trial Registry.
Sample Size Calculation
An academician who was a specialist in biostatistics performed a power analysis (The G*Power 3.1 manual) to determine the sample size. With 0.95 power, an acceptable Type I error was determined to be 0.05 with at least 40 children per group with an effect size of 0.3 across all groups.
In the G power analysis, the study sample size was determined as at least 40 children for each group according to the one-way analysis of variance for the comparison of mean reported fear and pain scores. For eligibility criteria, children were included in the study if they were aged between 6 and 12 years; had surgery for the first time; had outpatient surgery and only one operation at a time; could speak Turkish. Children were excluded in the study if they had genetic or congenital disease, had a chronic disease, and had previous surgery.
Randomization
The patients were allocated by blocked randomization based on gender and age. Participants were distributed to groups with a computerized random number table. Before starting the procedure for the study, participants were randomized among pediatric patients aged 6 to 12 years who came to the pediatric surgery clinic for operation by the primary investigator (PI). Of the 211 children evaluated for participation, a total of 79 were excluded for refusal to participate (n = 8), genetic or chronic disease (n = 43), or previous surgical experience (n = 28). A total of 132 were enrolled, including 44 in the educational AG, 44 in the documentary group, and 44 in the control group (Figure 1).
The researcher prepared the sociodemographic information form based on the literature. The form included questions regarding socio-demographic characteristics, hospitalization, and surgical experiences of the child (Table 1). Researchers completed the forms with face-to-face interviews.
Table 1Characteristics of Children (n = 132)
Characteristics
AG (n = 44)
DG (n = 44)
CG (n = 44)
P
Age (year) ±SD
8.80 ± 1.99
8.84 ± 1.92
8.84 ± 1.92
0.992
n
%
n
%
n
%
Gender
Girl
22
50.0
22
50.0
22
50.0
1.000
Boy
22
50.0
22
50.0
22
50.0
Diagnosis
General Surgery
11
25.0
10
22.8
14
31.8
.093
Day Surgery
33
75.0
34
77.2
30
68.2
Parent with child
Mother
40
90.9
40
90.9
41
93.2
.906
Father
4
9.1
4
9.1
3
6.8
Experience of hospitalization
Yes
19
43.2
14
31.8
15
34.1
.503
No
25
56.8
30
68.2
29
65.9
Experience of family's hospitalization
Yes
7
15.9
9
20.5
2
4.5
.081
No
37
84.1
35
79.5
42
95.5
AG, Animation Group; DG, Documentary Group; CG, Control Group; X, Mean; SD, Standard Deviation.
adapted this same scale for pediatric patients as the Children's Fear Scale. This scale includes 5 different facial expressions. This scale, graded between 0 and 4 ("0" is no fear, "4" is maximum fear), is a reliable and valid measurement tool for assessing fear.
The Wong and Baker Faces Pain Rating Scale was used to determine the level of pain in children between 3 and 18 years of age. This scale includes six different facial expressions and is scored between 0 and 10 ("0" is no pain, "10" is maximum pain). It is a reliable and valid measurement tool for acute pain assessment, and it does not require words or numeric values.
Data Collection
All the children's and parents’ written, and verbal informed consent were obtained before the study. Parents who did not want to participate in the study were assured that this would not have any adverse effect on their child's treatment. On the morning of surgery (about 1 to 2 hours before surgery), the sociodemographic information form was administered to children and parents chosen for the study. And then, both the children and the parents were asked to complete the Children's Fear Scale. Children watched an educational animated movie or documentary movie with VR, according to the study groups. The movies lasted around 3 to 4 minutes. After watching the movie, children and parents completed separately the Children's Fear Scale. Children, parents, and nurses completed separately Wong-Baker Faces Pain Rating Scale when the children returned to their room and after one hour postoperatively. Parents and nurses rated the child's pain numerically (from 0 to 10). Nurses were blinded to which movie the children saw and to each other for the score of fear and pain in postoperative periods.
Procedure
The randomization of the study was selected according to the clinic's monthly operating lists. The list was rechecked at the beginning of each week and every day of surgery (patients whose surgery was postponed were considered). In the pediatric surgery outpatient clinic of the same hospital, sample selection was made by randomization among the patients who met the inclusion criteria. In the study, randomization was done according to 3 groups. The first group, the second group, and the third group were the Education AG, the Documentary Movie Group (DG), and the Control Group (CG), respectively.
Preoperative preparation for surgery was completed by the surgery preparation nurse of the clinic. The protocol and routine procedures of the clinic were performed for each child included in the study. Routine procedures of the clinic included informing the child and parent about the surgery and answering questions. A nurse gave verbal information to the child and parent about the preparation for surgery when they came to the first appointment. This information included all children and parents participating in the study. The clinic and the operating room were introduced to the child who came to the hospital on the day of surgery and the parent. The child and parent were placed in a room reserved for them by a nurse. The nurse evaluated vital signs and assessed for fever and pain. Data was collected by IP in the preoperative period by using the "Demographic Form" containing the socio-demographic characteristics of the children. In the preoperative period, the child and parent were asked to score fear of child by using the “Children's Fear Scale” with different time intervals (2 times at 5 to 30 minutes before and after the watching video). Children in VR groups were told to watch the video by wearing VR glasses. However, it was not disclosed which VR group the child was. In terms of infection risk, VR was disinfected before and after each use.
The child was taken to the operating room according to the operating list order. As soon as the operation was completed, the child was taken to the postanesthesia care area. After waiting in this area for about half an hour, the child came to the patient room at the surgery clinic. Immediately after arriving in the room and 1 hour later, the child was asked to evaluate the child's pain using the Wong-Baker Faces Scale from the child, the parent, and the nurse. The pain assessment of the child was made by the same nurses and the nurses were blinded to the VR groups. Acetaminophen was prescribed to all patients for postoperative pain in the clinic's protocol. Patients received postoperative analgesic medication, excluding opioids.
Group 1: Educational Animation Group
An educational animated movie, which takes about three minutes and sixteen seconds long was watched in this group. The educational animated movie was designed by the PI. The content of this movie included all routine procedures of preoperative preparation and postoperative for the child and the parent in the pediatric surgery clinic. These procedures included introducing the clinic, starting from the first visit of the child and parent to the hospital, and evaluating the child's general physical examination and vital signs. Also, the education content included information about when and how the child should wear the surgical gown, how to go to the operating room, and the postoperative process and pain assessment. Children watched the educational animated movie using VR goggles in a 3-Dimensional (3D) environment.
Group 2: Documentary Group
This video was a documentary movie with instrumental music, which takes about 3-4 minutes and includes forests, trees, and flowers. The documentary movie was selected by the researchers and consultant, considering children's cognitive levels. This group was created to create a parallel to the educational AG. In other words, another video was shown to the other group with the same tool (VR) to understand whether VR or the content being watched is more effective.
Group 3: Control Group
Routine surgery preparation procedures of the clinic were applied. No attempt was made to the child included in this group. The data collection process was done in the same way as for VR groups. Only the fear rating was made differently from the VR groups (2 times at 5 to 30 minutes without watching videos).
Data Analysis
Statistical analyses were made using IBM SPSS Statistics 25.0 (IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.) package program. The significance level was set at 0.05 for all analyses. Numeric data were evaluated using mean, standard deviation, median, minimum, and maximum values whereas categorical data were evaluated using frequency and rate values. The normal distribution of the data was evaluated using the Kolmogorov-Smirnov and Shapiro-Wilk tests. The sample characteristics of the groups were compared with the chi-square test and one-way ANOVA test (variance analysis). Pre- and post- variation of fear scores (group effects, pre-and post-effect, and interaction effect) in the educational animated movie, documentary movie, and control groups were examined with Nonparametric Brunner-Langer model (F1-LD-F1 design) using R 3.3.1 software (R software, version 3.3.1, package: nparLD, R Foundation for Statistical Computing, Vienna, Austria; http://r-project.org). After the Brunner-Langer model, pre-and post-variation were not found similar (interaction<0.05). Pre- and post-comparison were separately made using the Wilcoxon Signed-Rank test in each group. The difference between post and pre-scores was calculated and the differences between groups were compared using the Kruskal Wallis test. After the Kruskal-Wallis test, paired comparisons were performed using the Dunn test, and Bonferroni correction was performed for P values. Harmony between child and parent was evaluated using Intraclass Correlation Coefficient in the first measurement. Pre- and post-variation of pain scores in each AG, DG, and CG were compared using the Kruskal Wallis test. After the Kruskal-Wallis test, paired comparisons were performed using the Dunn test, and Bonferroni correction was performed for P values. Child-parent harmony and child-nurse harmony in pain scores found with the calculation of the mean of two measurements were evaluated using the Intraclass Correlation Coefficient.
Findings
Sample Characteristics
Children's age, gender, and diagnosis, the parents accompanying the children in the preoperative period, the hospitalization experience of the child, and the surgical experience of a family member were homogeneous (Table 1).
Fear Scores
Children's self-report of fear showed that the variation of children's fear scores (pre-and-post) was not similar (interaction p-value <0.001). For this reason, pre-and post-comparison was conducted with the Wilcoxon Signed Rank Test in each group. Accordingly, no change was seen in the fear score in the control group whereas fear scores in AG and DG statistically decreased (AG P < .001 and DG P < .001) (Table 2). The difference between post- and pre-fear scores was calculated, the intergroup comparison was conducted using the Kruskal Wallis test and the difference between groups was found statistically different (P < .001). Intergroup paired comparisons indicated an intergroup difference based on the Dunn test and Bonferroni correction p values (P < .001 and P < .001). Children in AG had lower fear scores than those in DG and CG. No statistically significant difference was found between DG and CG (P > .05). In the evaluation made by the children, it was observed that the amount of fear points decreases in AG compared to DG (Figure 2). When children's fear evaluation by parents was examined, the difference between post- and pre-fear scores was calculated, an intergroup comparison was conducted using the Kruskal Wallis test and, a statistically significant difference was found between the groups (P < .001). Intergroup paired comparisons indicated a difference between AG and CG, and DG and CG according to Dunn test and Bonferroni correction P values (P < .001 and P < .001, respectively). Children in AG had lower fear scores than those in DG and CG. No statistically significant difference was found between DG and CG (P > .05) (Table 3). In the evaluation made by the parents, it was observed that the amount of fear points decreases in AG compared to DG (Figure 3).
Table 2Comparison of Fear Scores According to Groups (Children n = 132)
Children's self-report of pain indicated a statistically significant difference between the pain scores after intergroup comparison was conducted using the Kruskal Wallis test (by calculating the mean score; P < .001). Intergroup paired comparisons indicated a difference between AG and DG and between AG and CG according to the Dunn test and Bonferroni correction P values (P < .001 and P < .001, respectively). Children in AG had lower pain scores than those in DG and CG. No statistically significant difference was found between DG and CG (P = .097). Children's pain evaluation by parents indicated a difference between the pain scores after intergroup comparison was conducted using the Kruskal Wallis test (by calculating the mean score) (P < .001). Intergroup paired comparisons indicated a statistically significant difference between AG and DG, between AG and CG, and between DG and CG according to the Dunn test and Bonferroni correction P values done after the Kruskal Wallis test (P < .001, P < .001 and P = .035, respectively). Children in AG had lower pain scores than those in DG and CG. A statistically significant difference was found between DG and CG (P = .035). Children's pain evaluation by the nurses indicated a significant difference between the pain scores after intergroup comparison was conducted using the Kruskal Wallis test (by calculating the mean score) (P < .001). Intergroup paired comparisons indicated a difference between AG and DG, between AG and CG, and between DG and CG according to Dunn test and Bonferroni correction P values (P < .001, P < .001, and p P = .029 respectively). Children in AG had lower pain scores than those in DG and CG. A statistically significant difference was found between DG and CG (P = .029) (Table 4) .
Table 4Groups’ Paired Comparisons According to Pain Score Evaluated by Child, Parent, and Nurse (Children n = 132)
Hospitalization has adverse effects on children and their experiences regarding hospitals are scary, disturbing, and unpleasant. Children usually perceive healthcare personnel, hospital environment, medical interventions, and surgical operations as a threat and they experience fear.
In this study, the preoperative preparation process and the postoperative period were designed as an educational animated movie for the pediatric patient. The study examined the effects of the different movie methods which educational animated movie and as a comparison the documentary movie on the fear and pain of children. In addition to education, distracting methods were used and the movies were watched with VR goggles that can provide 2D and 3D screening. Many studies used VR goggles as a non-pharmacological method in reducing fear and pain.
The VR used in this study attracted the attention of children between the ages of 6- to 12 and they were easily adapted to the application. Fear scores were lower in the educational AG than the documentary and control groups. Besides, no statistically significant difference was found between the pain scores of the documentary group and the control group. Aytekin et al stated that using a distraction technique in children was effective in decreasing anxiety and tension in the preoperative period.
Another study conducted with children between 6 and 12 and found that playing games in the preoperative period were effective in decreasing fear of surgery.
In another study conducted with the same age group, one group received an education, and the other received education and played games. Study results indicated that fear of surgery was lower in the group that received education and played games.
Video distraction and parental presence for the management of preoperative anxiety and postoperative behavioral disturbance in children: a randomized controlled trial.
Additionally, distraction techniques such as therapeutic plays, music, computer games, cartoons, books with pictures and non-pictures were also effective in decreasing fear.
Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a randomized controlled trial.
This study also showed similar results with the literature as preoperative education was also used as a distraction technique. No studies were found that prepare an education in the form of animation for children, although preoperative education for pediatric patients was prepared in the studies conducted.
Postoperative pain may affect children's ability to cope with surgery and hinder their recovery. Children need to have decreased pain after surgery.
A randomized controlled trial of the effectiveness of a therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: study protocol.
The present study included interventions to decrease children's pain in the postoperative period. Pain scores were lower in the educational AG than the documentary and control groups. In addition, no statistically significant difference was found between the pain scores of the documentary group and the control group. Previous studies showed that preoperative education is effective in decreasing postoperative pain.
A randomized controlled trial of the effectiveness of a therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: study protocol.
These study results are like the literature in this respect. However, the literature also includes studies that do not show similarity with this study. Setoodeh et al, 28 found that preoperative verbal education given to children aged between 9 and 12 is not effective in decreasing postoperative pain. Buyuk Tural and Bolısık
found that education including verbal explanation, pamphlets, slide shows, and videos was not effective in decreasing postoperative pain in children aged 6 and 12 years old. Pediatric nursing includes primary nursing care practices, family-centered care, and atraumatic care. Previous studies indicated that non-pharmacological methods such as occupational therapy, games, music, cartoons, and videos bringing the artistic side into the fore are used in decreasing postoperative pain such as other health care practices.
Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a randomized controlled trial.
Education material prepared for children in this study adds an artistic element to pediatric nursing and comprises family-centered care. The education given before surgery includes pamphlets, coloring books, slide shows, or verbal information.
A systematic review detected non-pharmacological methods stopping postoperative pain in children in different age groups. These methods include informing, breathing exercises, touching, music, positioning, massage, distraction, and imagining. Among these studies, there was no specially prepared educational material or video for nursing.
Efficacy of non-pharmacological methods of pain management in children undergoing venipuncture in a pediatric outpatient clinic: a randomized controlled trial of audiovisual distraction and external cold and vibration.
Effectiveness of animated cartoon as a distraction strategy on level of pain among children undergoing venipuncture at selected hospital research officer (CREHPA).
The effect of distraction techniques watching cartoon animation to pain response during infusion of preschool children’ s in Rsud Sayang Kabupaten Cianjur.
However, no educational animated movie designed particularly for children was found in the literature. This was the first study to evaluate the impact of animation to prepare children for a planned procedure. The educational animated movie prepared for preoperative pediatric patients is an effective, interesting, and useful method in reducing preoperative fear and postoperative pain. This educational and distraction method can be designed and used to prepare children for many medical procedures.
Limitations
Some of the children evaluated within the scope of the study had surgery experience at least once, or they were admitted to the clinic to have surgery due to their chronic disease. In such cases and after giving information about the research, children who did not agree to participate were excluded from the research. The preoperative preparation and postoperative pain protocol of the clinic where the study was conducted was applied and could not be excluded during the study process.
Conclusion
Fear and pain were less common in the educational AG. The educational animated movie (with VR) describing surgery procedures for children is an effective method in decreasing preoperative fear and postoperative pain. Clinical non-pharmacological methods are recommended to be used in decreasing children's pain and fear in the preoperative period. This study examined the effect of educational animated movie describing surgery procedures on preoperative fear and postoperative pain. Randomized controlled studies found that the establishment of protocols and care standards including practices positively affecting fear and pain during surgery preparation will support children and parents and increase the quality of care.
In the surgical clinics, the procedures to be done to the child in the preoperative period should be explained according to the age group. In this process, educations gave in a fun and practical way that will attract the attention of the child facilitate the adaptation to practice of the child. The use of non-pharmacological methods, which are especially effective in reducing the fear and pain of the child, increases the efficiency of education. Among these methods, the use of VR and animated movie, which attract the attention of children between the ages of 6 to 12, is very effective in reducing pain and fear. However, new studies were needed in this field. More studies can be recommended on nursing education programs specific to the age groups of children for the management of fear and pain in the preoperative period.
Acknowledgments
The authors thank all of the children and parents who have participated in this research and the academic head of department, the nurses and staff of the Pediatric Surgery Clinic at Ege University for their support.
References
Li WHC
Chung JOK
Ho KY
Kwok BMC.
Play interventions to reduce anxiety and negative emotions in hospitalized children.
Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a randomized controlled trial.
Video distraction and parental presence for the management of preoperative anxiety and postoperative behavioral disturbance in children: a randomized controlled trial.
A randomized controlled trial of the effectiveness of a therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: study protocol.
Efficacy of non-pharmacological methods of pain management in children undergoing venipuncture in a pediatric outpatient clinic: a randomized controlled trial of audiovisual distraction and external cold and vibration.
Effectiveness of animated cartoon as a distraction strategy on level of pain among children undergoing venipuncture at selected hospital research officer (CREHPA).
The effect of distraction techniques watching cartoon animation to pain response during infusion of preschool children’ s in Rsud Sayang Kabupaten Cianjur.
Clinical Trial Registration: National Institutes of Health (NIH), ClinicalTrials.gov, NCT04176822.
Conflict of interest: Authors have reported no relevant financial and personal relationships with other individuals or organizations that could inappropriately affect their study. No conflict of interest was declared by the authors.
Funding: This study was supported by Ege University Institute of Health Sciences (Doctorate Program).
Brunner Langer method result.
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