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

NCT07145203 | Completed DMC

• 1 other identifier: IRB R-2024/A/129/N
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Stress; Pain; Patient Satisfaction; Patients Undergoing Colonoscopy

Keywords

Virtual Reality; Anxiety; Stress; Pain; Patient Satisfaction; Palestinian Patients; Colonoscopy

Outcome Measures

Primary Outcomes (2)

• State-Trait Anxiety Inventory (STAI)

  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)

  before colonoscopy and then 60 minutes post-procedure

• Perceived Stress Scale (PSS-10)

  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).

  before colonoscopy and then 60 minutes post-procedure

Study Arms (2)

VR group

EXPERIMENTAL

The VR intervention utilized a head-mounted VR headset with built-in headphones. Patients selected VR environments from a predefined list of natural scenes, including tropical beach, diving, forest, and snowy landscape, each accompanied by relaxing music and nature sounds. The Guided Meditation VR application from Cubicle Ninjas (https://guidedmeditationvr.com/) provided 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 experienced nausea, dizziness, or requested removal.

Device: Meta Quest 2 VR headset

control group

NO INTERVENTION

Participants in the control group received only standard care according to the hospital's protocol during the colonoscopy procedure.

Interventions

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.

VR group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Rafidia Surgical Governmental Hospital

Nablus, West Bank, Palestinian Territories

Location

Related Links

• the website Guided Meditation VR application, developed by Cubicle Ninjas Agency

MeSH Terms

Conditions

Anxiety Disorders; Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants in the VR group wore a VR headset during the colonoscopy procedure, while the control group received standard care without VR. The intervention used the Guided Meditation VR application developed by Cubicle Ninjas Agency, featuring immersive 360-degree natural environments such as tropical beach, diving, forests, and snowy landscapes. Patients chose one environment accompanied by relaxing music and nature sounds. VR sessions lasted 15 to 30 minutes during the colonoscopy, with the headset worn to immerse patients in the selected environment. The session was stopped if the patient experienced discomfort or requested removal.

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: September 10, 2024
• Primary Completion: December 30, 2024
• Study Completion: February 10, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)