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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Satisfaction
• Intervention / Treatment: Device: Virtual reality

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bolu, Turkey, 14030
    • Bolu Abant İzzet Baysal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; 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; Immersive virtual reality tour of the operating theatre before surgery and distraction methods both using VR headset
No Intervention: Control Group; The control group received conventional care and education regarding the perioperative process of surgery.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Virtual Reality; Parental Satisfaction
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2019_78

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No