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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04824690
• Other study ID #: 2019_78
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: March 2021
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Satisfaction

Intervention

Device:
• Virtual reality
Immersive virtual reality tour of the operating theatre before surgery and distraction methods both using VR headset

Locations

Country	Name	City	State
Turkey	Bolu Abant Izzet Baysal University	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.