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Clinical Trials/NCT04824690
NCT04824690
Completed
Not Applicable

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

Abant Izzet Baysal University1 site in 1 country70 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Abant Izzet Baysal University
Enrollment
70
Locations
1
Primary Endpoint
Preoperative anxiety assessed by the Children's State Anxiety (CAM-S)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
August 31, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aykut Turgut

Research Assistant

Abant Izzet Baysal University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Preoperative anxiety assessed by the Children's State Anxiety (CAM-S)

Time Frame: This is measured right before the child goes into operating theatre / separating from his/her parents.

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

Secondary Outcomes

  • Parental Satisfaction assessed by PedsQL Health Care Satisfaction Scale(This is measured immediately after the intervention.)
  • Postoperative anxiety assessed by the Children's State Anxiety (CAM-S)(This is measured immediately after the surgery.)
  • Postoperative Pain assessed by the Wong-Baker Faces Pain Rating Scale(This is measured immediately after the surgery.)

Study Sites (1)

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