The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children

Study Overview
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Brief Summary
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An immersive virtual reality (VR) tour of the operating theater before surgery could reduce preoperative anxiety. The aims of this study were to analyze whether a preoperative virtual reality tour shows a reduction in anxiety in children and an increase in parental satisfaction.

Detailed Description
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Children who will undergo surgery for the first time and their families were randomly allocated into the control or VR group. The control group received conventional education regarding the perioperative process of surgery. The VR group watched a 1.5-minute VR video showing the operating theater and explaining the perioperative process. The main finding was preoperative anxiety evaluated using the Children's State Anxiety (CSA) before surgery. Secondary findings included children's postoperative pain ratings using Wong-Baker Faces Pain Rating Scale and parental satisfaction scores using PedsQL Health Care Satisfaction Scale

Official Title
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The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children

Conditions
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Anxiety, Pain, Satisfaction

Intervention / Treatment
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* Device: Virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 4-10 years old ASA grade I or II General anesthesia Elective surgery Exclusion Criteria: Children who have had previous surgery history Local anesthesia or emergency surgeries Premature or congenital disease history Having visual and hearing impairment Mental and developmental retardation Having a history of epilepsy and seizures Patients taking psychoactive drugs

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Group<br>The virtual reality group watched a 1.5-minute VR video showing the operating theater and explaining the perioperative process. After the surgery, this group watched cartoons during the first standard nursing procedures after the effect of the anesthesia wore off. | Device: Virtual reality<br>* Immersive virtual reality tour of the operating theatre before surgery and distraction methods both using VR headset<br>|
| No Intervention: Control Group<br>The control group received conventional care and education regarding the perioperative process of surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative anxiety assessed by the Children's State Anxiety (CAM-S) | The CAM-S scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to Pretend that all of your worried or nervous feelings are in the bulb or bottom part of the thermometer. If you are a little bit worried or nervous, the feelings might come up in the thermometer just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line on the thermometer showing how much worry or nervousness you feel. Min score : 0 & Max score : 10 | This is measured right before the child goes into operating theatre / separating from his/her parents. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain assessed by the Wong-Baker Faces Pain Rating Scale | The scale is used around the world with people ages 3 and older. Min score : 0 & Max score : 5 | This is measured immediately after the surgery. | 
| Parental Satisfaction assessed by PedsQL Health Care Satisfaction Scale | Parents answered the following scale questions by indicating how satisfied they are with the services provided to them and their children. Min score : 0 & Max score : 100 | This is measured immediately after the intervention. | 
| Postoperative anxiety assessed by the Children's State Anxiety (CAM-S) | The CAM-S scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to Pretend that all of your worried or nervous feelings are in the bulb or bottom part of the thermometer. If you are a little bit worried or nervous, the feelings might come up in the thermometer just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line on the thermometer showing how much worry or nervousness you feel. Min score : 0 & Max score : 10 | This is measured immediately after the surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Pain, Parental Satisfaction, Virtual Reality