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

Sponsor
Abant Izzet Baysal University (Other)
Overall Status
Completed
CT.gov ID
NCT04824690
Collaborator
(none)
70
1
2
6
11.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual reality
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Aug 31, 2019
Actual Study Completion Date :
Aug 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Preoperative anxiety assessed by the Children's State Anxiety (CAM-S) [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 Outcome Measures

  1. Postoperative Pain assessed by the Wong-Baker Faces Pain Rating Scale [This is measured immediately after the surgery.]

    The scale is used around the world with people ages 3 and older. Min score : 0 & Max score : 5

  2. Parental Satisfaction assessed by PedsQL Health Care Satisfaction Scale [This is measured immediately after the intervention.]

    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

  3. Postoperative anxiety assessed by the Children's State Anxiety (CAM-S) [This is measured immediately after the surgery.]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bolu Abant İzzet Baysal University Bolu Turkey 14030

Sponsors and Collaborators

  • Abant Izzet Baysal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aykut Turgut, Research Assistant, Abant Izzet Baysal University
ClinicalTrials.gov Identifier:
NCT04824690
Other Study ID Numbers:
  • 2019_78
First Posted:
Apr 1, 2021
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aykut Turgut, Research Assistant, Abant Izzet Baysal University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2021