Virtual Reality Therapy for Pancreatitis

Recruiting at 1 trial location

Overseen By Stephen Pandol, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Seizures, Cognitive impairment, Pancreatic tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 Participants Needed

Trial Summary

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 Gut Directed VR for pancreatitis?

Cognitive-behavioral therapy (CBT), which is part of the Gut Directed VR treatment, has shown effectiveness in improving outcomes like pain-related disability and depression in other chronic pain conditions. This suggests potential benefits for patients with chronic pancreatitis, although it hasn't been specifically tested for this condition yet. ^{1 2 3 4 5}

Is virtual reality therapy safe for treating gut-related conditions?

Research on virtual reality therapy for gut-related conditions like functional dyspepsia and irritable bowel syndrome suggests it is generally safe for humans, as studies have focused on its potential to relieve pain without significant side effects. ^{6 7 8 9 10}

How is Gut Directed VR therapy different from other treatments for pancreatitis?

Gut Directed VR therapy is unique because it uses virtual reality to deliver cognitive-behavioral therapy (CBT), which is a psychological treatment that helps change negative thought patterns, in a more engaging and immersive way. This approach is different from traditional treatments like pain medications or mindfulness therapy, as it combines technology with psychological techniques to potentially improve pain management and quality of life for pancreatitis patients. ^{1 2 4 11 12}

What is the purpose of this trial?

The purpose of the research is to test the feasibility and preliminary impact of a home-based, standardized, gut-directed, virtual reality cognitive behavioral therapy (VR CBT) on clinical and functional outcomes of patients with chronic pancreatitis (CP) pain. The primary research procedures are questionnaires and biometric Fitbit data. The study will enroll adult patients with CP.

Eligibility Criteria

This trial is for adults with chronic pancreatitis or recurrent acute pancreatitis pain. Participants will need to complete questionnaires and wear a Fitbit to track biometric data.

Inclusion Criteria

I have been diagnosed with chronic pancreatitis or recurrent acute pancreatitis.

Patients from the national PROCEED cohort study

I can read and write in English.

Exclusion Criteria

I have cognitive issues that may affect my ability to follow study procedures.

I have been diagnosed with a pancreatic tumor.

Patients who have been enrolled in an interventional/therapeutic drug trial for chronic or recurrent pancreatitis within the last 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week home-based, standardized, gut-directed VR CBT to assess feasibility and impact on clinical and functional outcomes

8 weeks

Home-based intervention with virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, including health-related quality of life measurements and biometric data collection

4 weeks

Treatment Details

Interventions

• Gut Directed VR
• Sham Control VR

Trial Overview The study is testing a home-based virtual reality cognitive behavioral therapy (VR CBT) designed specifically for gut-related issues, comparing it against a sham VR control without therapeutic content.

Participant Groups

Group I: Gut Directed VR Experimental Treatment 1 Intervention

Group II: Sham VR Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

A pilot study involving 30 adults with chronic pancreatitis showed that an adapted Internet cognitive-behavioral therapy (CBT) program was highly acceptable, with 80% of participants rating it positively and 64.3% completing all lessons.

Participants who underwent Internet CBT experienced moderate to large reductions in pain intensity and interference, with 50% showing significant improvement compared to only 13% in the control group, indicating promising efficacy for managing pain in chronic pancreatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet Cognitive-Behavioral Therapy for Painful Chronic Pancreatitis: A Pilot Feasibility Randomized Controlled Trial. Palermo, TM., Law, EF., Topazian, MD., et al.[2023]

The Fear of Progression Questionnaire-Short Form (AP-FoP-Q-SF) was developed and validated for assessing fear of progression in acute pancreatitis patients, showing good internal consistency and a two-factor structure.

High fear of progression (FoP) was found to significantly correlate with factors such as age, recurrence of pancreatitis, and anxiety, leading to increased hospital costs and longer stays, indicating the importance of addressing FoP in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric validation of the fear of progression questionnaire-short form in acute pancreatitis patients. Ma, S., Yang, X., Xiang, S., et al.[2023]

In a study of 68 patients with chronic pancreatitis, higher pain intensity was significantly linked to lower quality of life (QOL), indicating that managing pain could be crucial for improving patient well-being.

Perceived self-blame for pain also emerged as a significant factor affecting QOL, suggesting that psychological processes play an important role in the overall experience of chronic pancreatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Abdominal Pain: Pain Beliefs, Pain Affect, and Distress as Determinants of Quality of Life in Patients With Chronic Pancreatitis. Keller, CE., Wilcox, CM., Gudleski, GD., et al.[2022]

In a study of 488 patients with chronic pancreatitis (CP), severe and constant pain were found to significantly worsen both physical and mental health, leading to higher rates of depression, anxiety, and sleep disturbances.

The findings suggest that addressing psychological comorbidities and sleep issues should be a routine part of managing patients with CP, as these factors are closely linked to the severity of pain experienced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Chronic Pancreatitis Pain Features With Physical, Mental, and Social Health. Yadav, D., Askew, RL., Palermo, T., et al.[2023]

Chronic pancreatitis causes varying levels of pain, influenced by both pancreatic and non-pancreatic factors, and the effectiveness of treatments can differ significantly among patients.

To improve future research on treatment outcomes, a standardized staging system for chronic pancreatitis patients is proposed, along with the use of the EORTC quality of life questionnaire to measure pain and quality of life consistently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating pain and the quality of life in chronic pancreatitis. Glasbrenner, B., Adler, G.[2023]

Active virtual reality (VR) therapy significantly improved symptoms of functional dyspepsia compared to sham VR, with a notable mean difference in symptom severity scores over a 2-week period.

The study found that VR was safe, with only one patient withdrawing due to nonserious adverse effects, suggesting it could be a beneficial treatment option for managing dyspepsia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. Cangemi, DJ., Montenegro, M., Spiegel, BMR., et al.[2023]

The IBS/VR program, designed to help patients with irritable bowel syndrome (IBS) through immersive virtual reality experiences, effectively teaches techniques related to the brain-gut axis and cognitive behavioral therapy.

Patient feedback led to 23 software changes, confirming the program's adaptability and relevance, with thematic saturation achieved after 15 interviews, indicating strong acceptance and potential efficacy of this innovative treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Validation of a Novel VR Program for Irritable Bowel Syndrome: A VR1 Study. Spiegel, BMR., Liran, O., Gale, R., et al.[2022]

Brain-gut behavior therapies are becoming essential in managing gut-brain interaction disorders, showing promising efficacy based on growing evidence.

These therapies should focus on gastrointestinal-specific issues, like gastrointestinal anxiety, to enhance their effectiveness for targeted patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future of Brain-Gut Behavior Therapies: Mediators and Moderators. Burton Murray, H., Ljótsson, B.[2023]

Functional brain imaging has revealed significant differences in brain activation between patients with irritable bowel syndrome (IBS) and healthy individuals, enhancing our understanding of how the brain perceives visceral pain.

Recent studies using brain imaging are beginning to uncover the underlying mechanisms of functional gastrointestinal symptoms and responses to treatment, although the complexity of these disorders presents challenges in data interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New directions in brain imaging research in functional gastrointestinal disorders. Ringel, Y.[2016]

Disorders of gut-brain interaction (DGBIs), such as functional dyspepsia and irritable bowel syndrome (IBS), are common and significantly impact patients' quality of life, highlighting the need for effective treatments.

Recent studies suggest that virtual reality (VR) technology may be a promising novel therapy for alleviating chronic abdominal pain associated with DGBIs, potentially offering a non-invasive alternative to traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? Lacy, BE., Cangemi, DJ., Spiegel, BR.[2023]

A novel telephone-based mindfulness therapy service was found to be feasible and usable for patients with chronic pancreatitis (CP), with a compliance rate of 67% and a high usability score of 79.3.

After 28 days of mindfulness therapy, patients with CP showed significant improvements in mental health-related quality of life, as indicated by better scores on both the SF-36 and the Pancreatitis Quality of Life Instrument (PANQOLI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-Based Mindfulness Therapy Intervention for Patients with Chronic Pancreatitis. Aivaliotis, VI., Lee, Y., Zia, J., et al.[2018]

Transcutaneous vagal nerve stimulation (t-VNS) and deep slow breathing (DSB) significantly increased cardiac vagal tone in 20 patients with chronic pancreatitis, indicating a potential method to enhance parasympathetic activity.

Despite the increase in cardiac vagal tone, neither t-VNS nor DSB improved pain sensitivity or gut motility, suggesting that chronic pain in chronic pancreatitis is complex and may require further research into neuromodulation techniques for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute physiological and electrical accentuation of vagal tone has no effect on pain or gastrointestinal motility in chronic pancreatitis. Juel, J., Brock, C., Olesen, SS., et al.[2022]

References

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

Internet Cognitive-Behavioral Therapy for Painful Chronic Pancreatitis: A Pilot Feasibility Randomized Controlled Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Psychometric validation of the fear of progression questionnaire-short form in acute pancreatitis patients. [2023]

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

Beyond Abdominal Pain: Pain Beliefs, Pain Affect, and Distress as Determinants of Quality of Life in Patients With Chronic Pancreatitis. [2022]

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

Association of Chronic Pancreatitis Pain Features With Physical, Mental, and Social Health. [2023]

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

Evaluating pain and the quality of life in chronic pancreatitis. [2023]

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

Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. [2023]

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

Qualitative Validation of a Novel VR Program for Irritable Bowel Syndrome: A VR1 Study. [2022]

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

Future of Brain-Gut Behavior Therapies: Mediators and Moderators. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

New directions in brain imaging research in functional gastrointestinal disorders. [2016]

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

Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? [2023]

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

Telephone-Based Mindfulness Therapy Intervention for Patients with Chronic Pancreatitis. [2018]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Acute physiological and electrical accentuation of vagal tone has no effect on pain or gastrointestinal motility in chronic pancreatitis. [2022]