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

Primary Purpose

Anxiety, Pain, Satisfaction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Pain, Parental Satisfaction, Virtual Reality

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bolu Abant İzzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Group

Control Group

Arm Description

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.

The control group received conventional care and education regarding the perioperative process of surgery.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
March 24, 2021
Last Updated
March 29, 2021
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04824690
Brief Title
The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children
Official Title
The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain, Satisfaction
Keywords
Anxiety, Pain, Parental Satisfaction, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group received conventional care and education regarding the perioperative process of surgery.
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
Immersive virtual reality tour of the operating theatre before surgery and distraction methods both using VR headset
Primary Outcome Measure Information:
Title
Preoperative anxiety assessed by the Children's State Anxiety (CAM-S)
Description
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
Time Frame
This is measured right before the child goes into operating theatre / separating from his/her parents.
Secondary Outcome Measure Information:
Title
Postoperative Pain assessed by the Wong-Baker Faces Pain Rating Scale
Description
The scale is used around the world with people ages 3 and older. Min score : 0 & Max score : 5
Time Frame
This is measured immediately after the surgery.
Title
Parental Satisfaction assessed by PedsQL Health Care Satisfaction Scale
Description
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
Time Frame
This is measured immediately after the intervention.
Title
Postoperative anxiety assessed by the Children's State Anxiety (CAM-S)
Description
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
Time Frame
This is measured immediately after the surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Bolu Abant İzzet Baysal University
City
Bolu
ZIP/Postal Code
14030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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