Completed

NCT Number: NCT07145203

Virtual Reality on Anxiety, Stress, Pain and Patient's Satisfaction Among Patients Undergoing Colonoscopy

The goal of this randomized controlled trial was to investigate the effect of Virtual Reality (VR) on anxiety, stress, pain, and patient satisfaction among Palestinian patients undergoing colonoscopy. The study aimed to determine the efficacy of VR as a non-pharmacological intervention to improve the patient experience during the procedure.

The main research hypotheses are:

H01: There will be no significant difference in anxiety levels between patients who receive immersive VR during colonoscopy and those who receive standard care.

H02: There will be no significant difference in perceived stress levels between patients who receive immersive VR during colonoscopy and those who receive standard care.

H03: There will be no significant difference in pain levels between patients who receive immersive VR during colonoscopy and those who receive standard care.

H04: There will be no significant difference in satisfaction levels between patients who receive immersive VR during colonoscopy and those who receive standard care.

Participants will:

Receive either a VR intervention or standard care during their colonoscopy. Wear a VR headset for 15-30 minutes, immersing themselves in a natural environment with relaxing music and nature sounds.

Complete assessments of anxiety, stress, pain, and satisfaction before and after the procedure using validated questionnaires.

Completed

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Health Behavior Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Satisfaction Patients Undergoing Colonoscopy Signs and Symptoms Stress Treatment Adherence and Compliance

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rafidia Surgical Governmental Hospital

Nablus, West Bank, Palestinian Territories

About this study

Title: Effect of Virtual Reality on Anxiety, Stress, Pain, and Patient Satisfaction among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial

Background: Colonoscopy is a common diagnostic and therapeutic procedure for gastrointestinal disorders but often causes anxiety, stress, and pain, which can complicate the procedure and increase sedative use. Virtual reality (VR) technology offers immersive, multi-sensory environments that may reduce these negative psychological and physical responses. This study aims to evaluate the effect of VR on anxiety, stress, pain, and patient satisfaction among Palestinian patients undergoing colonoscopy.

Methods: A randomized controlled trial will be conducted at the Endoscopy Unit of Rafidia Surgical Hospital in Nablus, Palestine. A total of 150 patients scheduled for colonoscopy will be randomly assigned to either the VR group (n=75) or the control group (n=75). The VR group will wear head-mounted VR devices for 15 to 30 minutes during the procedure, choosing from natural environments such as tropical beaches, forests, or snowy landscapes accompanied by relaxing music and nature sounds. Data on anxiety, stress, pain, and satisfaction will be collected through questionnaires administered by the researcher. The study duration is three months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients scheduled for elective colonoscopy
Patients older than 18 years
Patients with no history of previous colonoscopy procedures
Patients experiencing moderate to severe anxiety and stress

Exclusion criteria

Patients who have a history of psychiatric disorders, epilepsy, hypertension, or chronic pain.
Patients who are mute and could not read, or write, patients with visual, hearing, or cognitive impairment.
Patients who implanted hearing aids or cardiac pacemakers.
Patients who were given any anxiolytic, sedative, or hypnotic drugs before or during procedure.
Patients who were exposed to complications during the operation.

Treatment and study plan

Meta Quest 2 VR headset

Device

The VR intervention used a head-mounted VR headset with built-in headphones. Patients selected VR environments from a predefined list of four nature scenes (tropical beach, diving, forest, and snowy landscape) with relaxing music and nature sounds. Guided Meditation VR from Cubicle Ninjas (https://guidedmeditationvr.com/) featured 360-degree immersive nature environments with standardized calming background audio. VR was applied during the colonoscopy procedure, with sessions lasting 15 to 30 minutes and discontinued if the patient reported nausea, dizziness, or requested removal.

Primary outcomes

State-Trait Anxiety Inventory (STAI)

Time frame: before colonoscopy and then 60 minutes post-procedure

The STAI score ranges between 20-80, the higher score indicating greater anxiety. It is classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80)
Perceived Stress Scale (PSS-10)

Time frame: before colonoscopy and then 60 minutes post-procedure

The PSS-10 score can range from 0 to 40 with higher scores indicating higher perceived stress. It is classified as "no or low anxiety" (0-13), "moderate anxiety" (14-26), and "high anxiety" (27-40).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Virtual Reality on Anxiety, Stress, Pain and Patient's Satisfaction Among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial

Acronym: VR/RCT

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Aug 28, 2025
Registry last updated: Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed