The Effect of Virtual Reality on Pain and Anxiety in Patients Undergoing Upper Endoscopy

NCT06159829 | Completed

• 1 other identifier: CankırıKUE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Virtual reality (VR) is a tool that uses three-dimensional computer graphics-based technologies to make an individual feel as if they are physically in the virtual environment by misleading their senses. In recent years, the use of VR has been widely used in clinical applications such as anxiety disorders, pain, and stress coping VR can be used to relieve acute pain and anxiety in hospitalized patients and was shown in several studies to reduce pain and anxiety levels Aim: to evaluate the effect of virtual reality on anxiety and pain in patients who underwent upper endoscopy without sedation. Design: A single-centre, parallel-group, randomised control trial. Methods: The study sample consisted of 100 patients assigned to the intervention group (n=50) or control group (n=50) by stratified block randomization to control for sex distribution. During the upper endoscopy procedure, patients in the intervention group watched a video of natural scenery through virtual reality goggles. The study outcomes were anxiety and pain.

Conditions

Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Comparison of mean pain scores of patients in the intervention and control groups of during endoscopy

  Visuel Analog Scale (VAS) This one-dimensional measure of pain intensity is a reliable and easily applicable scale that is widely accepted in the literature. VAS is used to convert nonmeasurable variables into numeric values. The 10cm scale is labeled 0 ("no pain") at one end and 10 ("extreme pain") at the other, with values indicated at each cm in between

  Patients' pain levels were evaluated immediately after the procedure was completed.

Secondary Outcomes (1)

• Comparison of mean anxiety scores of patients in the intervention and control groups of during endoscopy

  Patients' anxiety levels were evaluated immediately after the procedure was completed.

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Virtual Reality glasses

Behavioral: experimental

Control

NO INTERVENTION

Patients in the control group underwent upper endoscopy following the standard protocol.

Interventions

experimental BEHAVIORAL

intervention group used VR with a natural landscape and relaxing musical accompaniment during the upper endoscopy procedure.

Virtual Reality

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Not using analgesics before the procedure,
• Not using anticoagulants within the last 24 hours,
• Having no vision or hearing problems
• Not receiving sedation
• Having no cognitive or psychiatric disorder that may affect understanding and communication

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Figen Erol Ursavaş

Aksu, Çankırı, 18200, Turkey (Türkiye)

Location

Study Officials

• Figen Erol Ursavaş

  Cankırı Karatekin Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 7, 2023
• Study Start: June 22, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)