The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in Children

Study Overview
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Brief Summary
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This study was conducted to evaluate the effects of virtual reality glasses and smartphone game applications on preoperative anxiety in children who have day surgery. The study comprised of 60 children (20 children in a virtual reality glass game application group, 20 children in a smartphone game application group, and 20 children in a control group). The approval of the ethics committee, permissions from the institutions, and informed voluntary approval of the children's were obtained to conduct the research. The data of the research were collected through the Children's Perioperative Multidimensional Anxiety Scale (CPMAS), physiological parameters of children were measured before, after and 90 minutes after the operation, and salivary cortisol sample taken before surgery in all of groups. Children in smartphone game application groups played a game for 15 minutes on a smartphone before the surgical operation, and standard care was given to children. Children in virtual reality game application groups played a game for 15 minutes on virtual reality glasses before the surgical operation, and standard care was given to children. Before the surgical operation, standard care was given to children in control groups. The value of p<0.05 was accepted statistically significant in the data analyses.

Detailed Description
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This randomized controlled experimental study was conducted to evaluate the effects of virtual reality glasses and smartphone game applications on preoperative anxiety in children who have day surgery. The study was performed between the ages of 7-13 years children at a tertiary hospital. Age, gender, surgery type, previous hospitalization experience and having chronic disease criteria of the children in control group (n=20), smartphone game application (n=20) and virtual reality glass game application (n=20) groups. Data were collected with Descriptive Characteristics Form for Children and Families, Children's Perioperative Multidimensional Anxiety Scale (CPMAS). Before the surgical operation, the game with a smartphone and virtual reality glass was played to the intervention groups for 15 minutes. Physiological parameters of children were measured before, after and 90 minutes after the operation. In addition, CPMAS was applied to children in preoperative assessment (Time 1), on the day of the operation (Time 2) and one month postoperatively (Time 3). Data were analyzed with post-power analysis, descriptive statistics, Kruskal-Wallis and Friedman Tests. The value of p<0.05 was accepted statistically significant in the data analyses.

Official Title
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The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in 7-13 Years Children

Conditions
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Preoperative Anxiety

Intervention / Treatment
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* Device: Virtual reality
* Device: Smartphone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 7 and 13 years of age Patients scheduled for day surgery Not having vision, hearing or speech problems Understands the Turkish language Not having a mental or neurological disability Not having a history of convulsions Exclusion Criteria: Does not understand the Turkish language the child is under 7 years old or 13 years older having vision, hearing or speech problems having a mental or neurological disability having a history of convulsions

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality glass game application<br> | Device: Virtual reality<br>* The Virtual Reality Glass game application reduces anxiety by distracting attention..The virtual reality glass game was played to intervention group for 15 minutes before surgery.<br>|
| Active Comparator: Smartphone game application<br> | Device: Smartphone<br>* The Smartphone game application reduces anxiety by distracting attention. Smartphone game was played to intervention group for 15 minutes before surgery.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Perioperative Multidimensional Anxiety Scale (CPMAS) Mean Score | According to the CPMAS, a score between 0-500 is obtained from the scale. A high score from the scale indicates a high level of perioperative anxiety. Change= in preoperative assessment (Time 1), on the day of the operation (Time 2) and one month postoperatively (Time 3). | An average of 45 days: In preoperative assessment (Time 1), on the day of the operation (Time 2) and one month postoperatively (Time 3). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological parameters | Heart Rate, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation. | One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation. | 
| Physiological parameters | Oxygen saturation, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation. | One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation. | 
| Physiological parameters | Blood pressure, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation. | One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation. |