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

NCT04824690 | Completed DMC

• 1 other identifier: 2019_78
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain; Satisfaction

Keywords

Anxiety; Pain; Parental Satisfaction; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative Pain assessed by the Wong-Baker Faces Pain Rating Scale

  This is measured immediately after the surgery.

• 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.

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Virtual reality DEVICE

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

Virtual Reality Group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 4-10 years old
• ASA grade I or II
• General anesthesia
• Elective surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant İzzet Baysal University

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: March 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)