AnxietyVR/RCTNCT07145203
Virtual Reality on Anxiety, Stress, Pain and Patient's Satisfaction Among Patients Undergoing Colonoscopy
A study testing Meta Quest 2 VR headset in people with Anxiety and Stress, run by Cairo University at 1 site in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Meta Quest 2 VR headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 10 Sep 2024to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Rafidia Surgical Governmental Hospital
Nablus, West Bank
About this study
Official title: Effect of Virtual Reality on Anxiety, Stress, Pain and Patient's Satisfaction Among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Anxiety, Stress, Pain, Patient Satisfaction, Patients Undergoing Colonoscopy
- Being tested
- Meta Quest 2 VR headset
- Keywords
- Virtual Reality, Anxiety, Stress, Pain, Patient Satisfaction, Palestinian Patients, Colonoscopy
- Medical subject headings
- Anxiety Disorders, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meta Quest 2 VR headsetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: before colonoscopy and then 60 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start10 Sep 2024
- Primary completion30 Dec 2024
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khulud "Mohammad Hasham" Hasham Mansor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145203
- Sponsor's protocol ID
- IRB R-2024/A/129/N
- Acronym
- VR/RCT
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) cannot be shared due to ethical concerns about participant privacy and the inappropriate use of data. Also, compliance with journal publication policies.
Publications
Mansor K, Aqtam I, Shouli M. Effects of Virtual Reality on Anxiety, Stress, Pain, and Patient Satisfaction Among Palestinian Patients Undergoing Colonoscopy: Randomized Controlled Trial. Health Sci Rep. 2026 Apr 27;9(5):e72420. doi: 10.1002/hsr2.72420. eCollection 2026 May.
PubMed 42058567
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Anxiety, Stress, Pain and Patient's Satisfaction Among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07145203
- Acronym / sponsor ID
- VR/RCT / IRB R-2024/A/129/N
- Conditions
- Anxiety, Stress, Pain, Patient Satisfaction, Patients Undergoing Colonoscopy
- Keywords
- Virtual Reality, Anxiety, Stress, Pain, Patient Satisfaction, Palestinian Patients, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: Meta Quest 2 VR headsetThe 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. |
| control group | No intervention | –Participants in the control group received only standard care according to the hospital's protocol during the colonoscopy procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meta Quest 2 VR headsetThe 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. | Device | VR group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Derived from this study: PubMed 42058567Mansor K, Aqtam I, Shouli M. Effects of Virtual Reality on Anxiety, Stress, Pain, and Patient Satisfaction Among Palestinian Patients Undergoing Colonoscopy: Randomized Controlled Trial. Health Sci Rep. 2026 Apr 27;9(5):e72420. doi: 10.1002/hsr2.72420. eCollection 2026 May.
- the website Guided Meditation VR application, developed by Cubicle Ninjas AgencyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) cannot be shared due to ethical concerns about participant privacy and the inappropriate use of data. Also, compliance with journal publication policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meta Quest 2 VR headset in people with Anxiety and Stress, run by Cairo University at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI) (time frame: before colonoscopy and then 60 minutes post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07145203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.