Virtual Reality Therapy for Inflammatory Bowel Disease

Overseen by Shirley Cohen-Mekelburg, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Disqualifiers: Epilepsy, Vision loss, Cardiac conditions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The research is studying virtual reality (VR)-directed brain-gut behavioral therapy (BGBT) as a pain treatment option for hospitalized patients with inflammatory bowel disease (IBD). This study is being done to learn if VR-directed BGBT is feasible and acceptable for patients with IBD in addressing pain in the hospital setting. The study hypothesizes that: * At least 75% of enrolled participants will complete the VR-directed BGBT inpatient program * Hospitalized patients with IBD will find VR-directed BGBT acceptable as a pain treatment option in the inpatient setting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Virtual Reality-Directed Brain Gut Behavioral Therapy for Inflammatory Bowel Disease?

Research shows that virtual reality (VR) can enhance therapy effectiveness and patient engagement in various conditions, such as improving mood in cancer patients and aiding cognitive-behavioral therapy for schizophrenia. This suggests that VR might also help in managing symptoms and improving the quality of life for those with Inflammatory Bowel Disease. ^{1 2 3 4 5}

Is virtual reality therapy safe for use in humans?

Research on virtual reality-based biofeedback therapy, used for conditions like pain and anxiety, shows it is generally safe and well-accepted by participants, including children and adolescents. Participants often report high motivation and a positive user experience, with no significant safety concerns noted in the studies. ^{6 7 8 9 10}

How is Virtual Reality-Directed Brain Gut Behavioral Treatment different from other treatments for inflammatory bowel disease?

Virtual Reality-Directed Brain Gut Behavioral Treatment is unique because it uses virtual reality (VR) to enhance the effectiveness of behavioral therapy, potentially improving patient engagement and outcomes by providing an immersive and interactive experience, unlike traditional treatments that do not incorporate VR technology. ^{1 2 4 5 11}

Research Team

Shirley Cohen-Mekelburg, MD, MS

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for hospitalized patients with Inflammatory Bowel Disease (IBD) who are interested in trying a new pain treatment. The study will test if a Virtual Reality (VR)-directed therapy can help manage their pain while they're in the hospital.

Inclusion Criteria

I have Inflammatory Bowel Disease and experience pain.

Hospitalized for management of IBD (inpatient medicine services at Michigan Medicine)

Exclusion Criteria

Patients that are currently pregnant

I do not have uncontrolled heart or brain conditions.

Patients with binocular vision loss

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo VR-directed brain-gut behavioral therapy (BGBT) as a pain treatment option during hospitalization

3 days

Inpatient setting

Follow-up

Participants are monitored for acceptability and satisfaction with the VR-directed BGBT through interviews and scales

1 week

1 visit (virtual or in-person)

Treatment Details

Interventions

• Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT) (Behavioural Intervention)

Trial Overview The intervention being studied is a VR-directed brain-gut behavioral therapy (BGBT). It's designed to see if using VR technology can be an effective way to treat pain for IBD patients during their hospital stay.

Participant Groups

Group I: Virtual reality-directed BGBT Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

Findings from Research

In a randomized crossover trial involving 50 cancer patients undergoing chemotherapy, Virtual Reality (VR) significantly improved mood states compared to Guided Imagery (GI), indicating its potential as a beneficial intervention for emotional well-being during treatment.

The VR intervention also led to statistically significant improvements in biophysical parameters like blood pressure and heart rate, although it did not show effectiveness in reducing symptoms of nausea, pain, or feeling sick.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. Ioannou, A., Paikousis, L., Papastavrou, E., et al.[2022]

Combining cognitive behavioral therapy (CBT) with virtual reality-assisted therapy (VRT) showed significant improvements in symptoms for treatment-resistant schizophrenia patients, particularly in auditory hallucinations and depressive symptoms.

The study, involving 10 participants who had previously undergone CBT, suggests that the combination of CBT and VRT may have a synergistic effect, leading to greater improvements than either therapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Benefits of Virtual Reality-Assisted Therapy Following Cognitive-Behavioral Therapy for Auditory Hallucinations in Patients with Treatment-Resistant Schizophrenia: A Proof of Concept. Dellazizzo, L., Potvin, S., Phraxayavong, K., et al.[2023]

Virtual reality (VR) has been shown to be an effective tool for managing acute pain, with 83% of the studies reviewed reporting decreased pain intensity when using VR compared to non-VR methods.

The effectiveness of VR in pain management is likely due to its ability to distract patients, highlighting the importance of creating immersive and engaging VR experiences to enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Virtual Reality Therapeutics for Acute Pain Management. Dreesmann, NJ., Su, H., Thompson, HJ.[2023]

This study will compare the effectiveness of virtual reality-based cognitive-behavioral therapy (VRcbt) to standard cognitive-behavioral therapy for psychosis (CBTp) in treating paranoid delusions in 106 patients with psychotic disorders over 8-12 weeks.

The primary outcome will measure changes in paranoid ideations in daily life using ecological momentary assessments, which could demonstrate whether VRcbt is more effective and cost-effective than traditional CBTp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial. Berkhof, M., van der Stouwe, ECD., Lestestuiver, B., et al.[2021]

The mobile game-based VR rehabilitation program (MoU-Rehab) significantly improved upper extremity function in stroke patients compared to conventional therapy, as measured by the Fugl-Meyer Assessment and other metrics.

The program was well-tolerated with no adverse effects reported, and patients expressed high satisfaction, indicating its feasibility as a rehabilitation tool for upper limb recovery after ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. Choi, YH., Ku, J., Lim, H., et al.[2019]

The study involved 58 outpatients with bulimia nervosa (BN) and binge eating disorder (BED), who were exposed to virtual reality environments featuring craved foods, resulting in significantly higher food craving and anxiety responses compared to a neutral environment.

The findings suggest that virtual reality cue exposure therapy (VR-CET) effectively triggers food-related cravings and anxiety in patients, indicating its potential as a therapeutic tool for treating eating disorders like BN and BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing virtual reality-based cue-exposure software: Which cue-elicited responses best discriminate between patients with eating disorders and healthy controls? Pla-Sanjuanelo, J., Ferrer-García, M., Vilalta-Abella, F., et al.[2020]

In a study involving 19 hospitalized children and adolescents with chronic illnesses, those receiving virtual reality treatment reported significantly higher perceived efficacy and acceptability compared to traditional cognitive-behavioral therapy.

The virtual reality program was well-received, showing high scores in immersion and feasibility, suggesting that technology-based treatments can enhance motivation and engagement in therapeutic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Emotional Well-being in Hospitalized Children and Adolescents With Virtual Reality: Usability and Acceptability of a Randomized Controlled Trial. Flujas-Contreras, JM., Ruiz-Castañeda, D., Gómez, I.[2021]

Biofeedback-based virtual reality (VR-BF) is a promising nonpharmacologic approach to pain management that could help reduce the need for opioids in children and adolescents after surgery, addressing the opioid epidemic's impact on this vulnerable population.

In a study involving 23 surgical patients, VR-BF was evaluated for its feasibility and acceptability, aiming to establish a treatment protocol that includes preoperative education and postoperative application to manage pain effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dataset used to refine a treatment protocol of a biofeedback-based virtual reality intervention for pain and anxiety in children and adolescents undergoing surgery. Orgil, Z., Karthic, A., Bell, N., et al.[2023]

This study is testing the feasibility of using biofeedback-based virtual reality (VR-BF) for pain management in children and adolescents undergoing surgery, with 70 participants aged 12-18 years involved in a randomized controlled trial.

The primary goal is to evaluate how well VR-BF can be integrated into perioperative care, while secondary aims include assessing its acceptability and initial effectiveness in reducing pain, anxiety, and opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of perioperative application of biofeedback-based virtual reality versus active control for pain and anxiety in children and adolescents undergoing surgery: protocol for a pilot randomised controlled trial. Orgil, Z., Johnson, L., Karthic, A., et al.[2023]

Virtual reality (VR) biofeedback (BF) therapy has been shown to effectively reduce anxiety, stress, and pain, with outcomes comparable to traditional biofeedback methods, based on a review of 18 studies involving mostly healthy adult participants.

Participants in VR-BF interventions reported higher motivation and better user experiences, suggesting that while VR may not yet be proven more effective than traditional BF, it offers advantages in engagement and attentional focus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Biofeedback in Health: A Scoping Review. Lüddecke, R., Felnhofer, A.[2022]

Virtual reality (VR) therapies have shown promise in effectively distracting patients from both acute and chronic pain, suggesting a new approach to pain management beyond traditional methods like opioids and physical therapy.

Clinical studies indicate that VR can be beneficial for various pain conditions, including fibromyalgia and phantom limb pain, by immersing patients in interactive environments that reduce their perception of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. Pourmand, A., Davis, S., Marchak, A., et al.[2018]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring the Benefits of Virtual Reality-Assisted Therapy Following Cognitive-Behavioral Therapy for Auditory Hallucinations in Patients with Treatment-Resistant Schizophrenia: A Proof of Concept. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Virtual Reality Therapeutics for Acute Pain Management. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Testing virtual reality-based cue-exposure software: Which cue-elicited responses best discriminate between patients with eating disorders and healthy controls? [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Promoting Emotional Well-being in Hospitalized Children and Adolescents With Virtual Reality: Usability and Acceptability of a Randomized Controlled Trial. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Dataset used to refine a treatment protocol of a biofeedback-based virtual reality intervention for pain and anxiety in children and adolescents undergoing surgery. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of perioperative application of biofeedback-based virtual reality versus active control for pain and anxiety in children and adolescents undergoing surgery: protocol for a pilot randomised controlled trial. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Virtual Reality Biofeedback in Health: A Scoping Review. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. [2018]