Virtual Reality on Anxiety, Stress, Pain and Patient's Satisfaction Among Patients Undergoing Colonoscopy
NCT ID: NCT07145203
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2024-09-10
2025-02-10
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
SUPPORTIVE_CARE
NONE
Study Groups
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VR group
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.
Meta Quest 2 VR headset
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.
control group
Participants in the control group received only standard care according to the hospital's protocol during the colonoscopy procedure.
No interventions assigned to this group
Interventions
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Meta Quest 2 VR headset
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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khulud "Mohammad Hasham" Hasham Mansor
Principal Investigator
Locations
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Rafidia Surgical Governmental Hospital
Nablus, West Bank, Palestinian Territories
Countries
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Related Links
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the website Guided Meditation VR application, developed by Cubicle Ninjas Agency
Other Identifiers
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IRB R-2024/A/129/N
Identifier Type: -
Identifier Source: org_study_id
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