IBS - Irritable Bowel SyndromeNCT06257472
Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome
A study testing Virtual Reality Headset in people with IBS - Irritable Bowel Syndrome, run by Anthony Lembo at 2 sites in United States.
Trial summary
In this study, the investigators conduct a remote, eight-week, two-arm, randomized controlled trial that assesses the benefits, primarily measured through the irritable bowel syndrome (IBS)-targeted HRQOL (health-related quality of life), of an immersive, disease-targeted virtual reality program compared to a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Virtual Reality Headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2024to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- 18 years or older
- Meet Rome IV criteria, as diagnosed either by a licensed physician or via self-report using the Rome IBS questionnaire, for IBS for any type: IBS-C (IBS with constipation), IBS-D (IBS with diarrhea), and IBS-M (mixed-type IBS)
Who cannot join
- Individuals with a comorbid disorder that may confound the diagnosis of IBS, including:
- celiac disease
- inflammatory bowel disease
- autoimmune disorders that affect the GI system
- history of bowel resection
- HIV/AIDS ( human immunodeficiency virus/acquired immunodeficiency syndrome)
Show all 20Show fewer
- diabetes with HgA1c>7.0
- neuroendocrine tumors
- microscopic colitis
- lactase deficiency
- eosinophilic bowel disease
- acute intermittent porphyria
- any other condition that a licensed physician believes can mimic IBS symptoms and undermine diagnostic certitude
- Patients using regular doses of opioid medications will also be excluded given the often-severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia
- No WiFi at home
- Any history of seizure
- Ongoing treatment for a GI cancer
- Major audiovisual impairment (complete blindness, deafness)
- Inability to understand English at 6th grade level
- Any events planned over the 8 weeks of the study that could end your ability to participate in the study, such as a medical procedure, vacation, or change in residence (Note: the study team can always delay enrollment)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome: A Randomized Trial Comparing Brain-Gut Directed VR vs. Sham VR
In this study, the investigators conduct a remote, eight-week, two-arm, randomized controlled trial that assesses the benefits, primarily measured through the irritable bowel syndrome (IBS)-targeted HRQOL (health-related quality of life), of an immersive, disease-targeted virtual reality program compared to a non-immersive virtual reality program for patients with IBS.
Read the detailed description
In this study, the investigators will conduct a decentralized, remote, eight-week, two-arm, randomized controlled trial of SynerGI, a disease-targeted, brain-gut directed, immersive VR program for people with IBS, versus sham VR delivered in a VR headset. Eligible participants will be assigned to a study arm using a 1:1 random number generator and will be blinded to allocation. Data analysts will also be blinded to allocation; only pre-specified staff who are uninvolved with data analyses will be unblinded for purposes of study administration (e.g., sending allocation-specific study materials). After completion of the treatment, participants will be invited to participate in an optional 30-minute semi-structured interview to better understand their experiences of VR treatment. Qualitative interviews will be audio-recorded and transcribed.
The primary aim of this study will be to assess the benefits of disease-targeted VR compared to sham VR on clinically relevant outcomes. The second aim will seek to determine patient-level predictors of treatment response to active VR therapy. The third aim will seek to understand patient experiences of VR to better inform the design of VR treatments for digestive diseases in the future.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Virtual Reality Headset
- Keywords
- Virtual Reality, IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
Participants will be mailed a Meta Quest 2 Headset. Participants will be asked to wear and use the VR headset for around 20 minutes each day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IBS/VR Program (SynerGI) | Experimental | Not described Receives: Device: Virtual Reality Headset |
| Sham VR Program | Sham comparator | Not described Receives: Device: Virtual Reality Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-targeted HRQOL (health-related quality of life)
The primary outcome will be an increase in IBS-QOL (quality of life) scores between baseline and week 8 for those on the study arm. Each question is positively scored 1-5, and the sum is normalized into a 0-100 score, with 100 being the highest reported quality of life and 0 being the lowest.
Measured: Baseline, after 4 weeks using device, after 8 weeks using device
Secondary outcomes (9)
GI (Gastrointestinal) Pain Intensity
A secondary outcome will be a decrease in PROMIS (Patient Reported Outcomes Measurement Information System) GI Pain scores scored on a scale of 1-5 with 1 being low pain intensity and 5 being high. These scores are summed for a raw score, which may be converted into a T-score.
Measured: Baseline, after 4 weeks using device, after 8 weeks using device
IBS symptom severity
A secondary outcome will be a decrease in patient reported IBS Symptom Severity Score (IBS-SSS).
Scored on a 0-500 scale.
- < 75 points - IBS considered in remission
- 75-174 - mild IBS
- 175-299 - moderate IBS
- 300-500 - severe IBS 5 measures
- # of days with abdominal pain x 10 - maximum score of 100
- 1-100 scale for abdominal pain severity
- 0-100 scale for abdominal distension severity
- 0-100 scale for satisfaction with bowel habits
- 0-100 scale for interference with life'
Measured: Weekly for 8 weeks
Visceral anxiety
A secondary outcome will be a decrease in patient reported Visceral Sensitivity Index (VSI) scores.
Each question is positively scored 1-6. 1 represents the most visceral anxiety and 6 represents no visceral anxiety.
The VSI items then are reversed scored, meaning that the 1-6 becomes 5-0. These reverse scores are then summed. The max score, representing severe visceral anxiety is 75. The minimum score is 0 (no visceral anxiety).
Measured: Baseline, after 4 weeks using device, after 8 weeks using device
Generalized anxiety
A secondary outcome will be a decrease in PROMIS (Patient Reported Outcomes Measurement Information System) Anxiety scores. Each question is positively scored 1-5 (meaning that 1 is no anxiety and 5 the highest anxiety), then summed for raw score, which may be converted into a T-Score.
Measured: Baseline, after 4 weeks using device, after 8 weeks using device
Maladaptive GI (Gastrointestinal) cognitions
A secondary outcome will be a decrease in patient reported Gastrointestinal Cognitions Questionnaire (GI-COG) scores.
Each question is scored positively from 0-4, then summed for raw score. Raw scores 0-19, 20-39, and 40-64 indicate mild catastrophizing, moderate catastrophizing, and severe catastrophizing respectively.
Measured: Baseline, after 4 weeks using device, after 8 weeks using device
Somatization
A secondary outcome will be a decrease in patient reported Patient Health Questionnaire (PHQ-15) scores.
Each question is positively scored 0-2, then summed for raw score. The total PHQ-15 score ranges from 0 to 30 and scores of ≥5, ≥10, ≥15 represent mild, moderate and severe levels of somatization, respectively.
Measured: Baseline, after 4 weeks using device, after 8 weeks using device
Increase in Symptom Relief
A secondary outcome will be an increase in patient reported "Adequate Relief" global assessment. This is a binary outcome (yes or no)
Measured: End of Study, which will occur after 8 weeks using device
Optional Individual Cognitive Interviews
Obtaining qualitative feedback from participants in the treatment group about their experiences with the SynerGI software
Measured: End of Study, which will occur after 8 weeks using device
Optional Rome IV Criteria assessment
Using the fourth version of the Rome Criteria, potential participants may self-diagnose themselves with IBS.
Measured: At screening/baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study startDec 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: Collaborator is taking lead; Entry is now duplicate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Two-armed blinded clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthony Lembo
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Sponsor-investigator, Anthony Lembo, The Cleveland Clinic
- Investigators
- Anthony Lembo, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257472
- Sponsor's protocol ID
- VR Study
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome: A Randomized Trial Comparing Brain-Gut Directed VR vs. Sham VR
- ClinicalTrials.gov ID
- NCT06257472
- Acronym / sponsor ID
- VR Study
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- Virtual Reality, IBS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Collaborator is taking lead; Entry is now duplicate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anthony LemboUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- Dec 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 Feb 2024 (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.
In this study, the investigators conduct a remote, eight-week, two-arm, randomized controlled trial that assesses the benefits, primarily measured through the irritable bowel syndrome (IBS)-targeted HRQOL (health-related quality of life), of an immersive, disease-targeted virtual reality program compared to a non-immersive virtual reality program for patients with IBS.
Detailed description
In this study, the investigators will conduct a decentralized, remote, eight-week, two-arm, randomized controlled trial of SynerGI, a disease-targeted, brain-gut directed, immersive VR program for people with IBS, versus sham VR delivered in a VR headset. Eligible participants will be assigned to a study arm using a 1:1 random number generator and will be blinded to allocation. Data analysts will also be blinded to allocation; only pre-specified staff who are uninvolved with data analyses will be unblinded for purposes of study administration (e.g., sending allocation-specific study materials). After completion of the treatment, participants will be invited to participate in an optional 30-minute semi-structured interview to better understand their experiences of VR treatment. Qualitative interviews will be audio-recorded and transcribed.
The primary aim of this study will be to assess the benefits of disease-targeted VR compared to sham VR on clinically relevant outcomes. The second aim will seek to determine patient-level predictors of treatment response to active VR therapy. The third aim will seek to understand patient experiences of VR to better inform the design of VR treatments for digestive diseases in the future.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-armed blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| IBS/VR Program (SynerGI) | Experimental | Device: Virtual Reality Headset |
| Sham VR Program | Sham comparator | Device: Virtual Reality Headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- 18 years or older
- Meet Rome IV criteria, as diagnosed either by a licensed physician or via self-report using the Rome IBS questionnaire, for IBS for any type: IBS-C (IBS with constipation), IBS-D (IBS with diarrhea), and IBS-M (mixed-type IBS)
Key exclusion criteria (20 listed)
- Individuals with a comorbid disorder that may confound the diagnosis of IBS, including:
- celiac disease
- inflammatory bowel disease
- autoimmune disorders that affect the GI system
- history of bowel resection
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 |
|---|---|---|
| Virtual Reality HeadsetParticipants will be mailed a Meta Quest 2 Headset. Participants will be asked to wear and use the VR headset for around 20 minutes each day for 8 weeks. | Device | IBS/VR Program (SynerGI), Sham VR Program |
Primary outcome
IBS-targeted HRQOL (health-related quality of life)
Time frame: Baseline, after 4 weeks using device, after 8 weeks using device
The primary outcome will be an increase in IBS-QOL (quality of life) scores between baseline and week 8 for those on the study arm. Each question is positively scored 1-5, and the sum is normalized into a 0-100 score, with 100 being the highest reported quality of life and 0 being the lowest.
9 secondary outcomes
GI (Gastrointestinal) Pain Intensity
Time frame: Baseline, after 4 weeks using device, after 8 weeks using device
IBS symptom severity
Time frame: Weekly for 8 weeks
Visceral anxiety
Time frame: Baseline, after 4 weeks using device, after 8 weeks using device
Generalized anxiety
Time frame: Baseline, after 4 weeks using device, after 8 weeks using device
Maladaptive GI (Gastrointestinal) cognitions
Time frame: Baseline, after 4 weeks using device, after 8 weeks using device
Somatization
Time frame: Baseline, after 4 weeks using device, after 8 weeks using device
Increase in Symptom Relief
Time frame: End of Study, which will occur after 8 weeks using device
Optional Individual Cognitive Interviews
Time frame: End of Study, which will occur after 8 weeks using device
Optional Rome IV Criteria assessment
Time frame: At screening/baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for IBS - Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Anthony Lembo, MD principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset in people with IBS - Irritable Bowel Syndrome, run by Anthony Lembo at 2 sites in United States.
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 3 inclusion and 20 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: withdrawn, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
IBS-targeted HRQOL (health-related quality of life) (time frame: Baseline, after 4 weeks using device, after 8 weeks using device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2025.