Hypnotherapy for Gastrointestinal Irritation

Overseen By Mariah Robran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: SIBO, Gastroparesis, Schizophrenia, Bipolar, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether hypnotherapy, delivered through digital sessions, can improve symptoms related to gastrointestinal (GI) issues such as bloating and nausea. Participants will either undergo seven hypnotherapy sessions or access an educational module about GI conditions. This trial suits those with GI discomfort, like bloating or nausea, but not severe GI diseases such as gastroparesis or inflammatory bowel disease. Participants must have a smartphone to access the sessions and educational content. As an unphased trial, this study provides an opportunity to explore innovative treatment options for GI discomfort.

Do I need to stop my current medications for the trial?

You can continue taking your current medications as long as the doses remain stable and are not changed during the study period.

What prior data suggests that hypnotherapy is safe for gastrointestinal irritation?

Research has shown that hypnotherapy is safe for various stomach and digestive issues. Studies have found it to be well-tolerated with very few side effects. Specifically, digital gut-directed hypnotherapy has raised no safety concerns, as participants in past studies did not report serious problems with this treatment. Hypnotherapy has also improved patient well-being, making it both effective and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care options for gastrointestinal irritation, which often include medications like antispasmodics, laxatives, and dietary changes, hypnotherapy offers a completely different approach. Hypnotherapy is unique because it uses guided relaxation techniques to potentially ease symptoms by influencing gut-brain interactions. Its delivery method is also distinctive; patients can access pre-recorded sessions on their own devices, making it convenient and non-invasive. Researchers are excited about hypnotherapy's potential to provide relief without medication side effects, offering a holistic and accessible alternative for managing chronic GI conditions.

What evidence suggests that hypnotherapy might be an effective treatment for gastrointestinal irritation?

Research has shown that hypnotherapy can help with stomach and digestive issues, especially irritable bowel syndrome (IBS). One study found that 65% of IBS patients felt much better after 12 sessions of gut-focused hypnotherapy. Another review confirmed that hypnotherapy can improve digestive symptoms in the short term. Digital versions of gut-directed hypnotherapy have also reduced stomach pain and improved bowel movements. In this trial, participants will receive either hypnotherapy or an educational module. Overall, these findings suggest hypnotherapy could effectively manage digestive problems. ^{1 3 4 6 7}

Who Is on the Research Team?

Xiao Jing (Iris) Wang, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with upper GI symptoms or bloating, who have reliable internet access and a smartphone. They must have undergone specific gastric emptying tests and not be changing doses of cannabinoid substances during the study. Exclusions include untreated H. pylori infection, significant psychiatric illness, substance abuse disorders, certain cognitive impairments, and various gastrointestinal conditions.

Inclusion Criteria

Patients with known disaccharide intolerances may be included if dietary restrictions are maintained during the duration of the study

Patients will be proficient in English language for comprehension of content

I have upper GI issues like stomach pain, nausea, or bloating.

Exclusion Criteria

I have bloating and constipation but no untreated pelvic floor dysfunction.

I do not have severe psychiatric illnesses like schizophrenia, bipolar disorder, or major depression with suicidal thoughts.

I can give informed consent and have no other diseases that could affect the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either hypnotherapy treatment or an educational module over 12 weeks

12 weeks

Sessions delivered digitally

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Electronic symptom questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Hypnotherapy

Trial Overview The trial is testing whether hypnotherapy sessions delivered digitally can alleviate upper gastrointestinal symptoms. Participants will also receive an educational module as part of the intervention to help manage their condition.

How Is the Trial Designed?

Group I: Hypnotherapy Experimental Treatment 1 Intervention

7 pre-recorded hypnotherapy sessions delivered over 12 weeks via patient's own electronic device. Sessions are approximately 40 minutes long.

Group II: Educational module Experimental Treatment 1 Intervention

Patient's will be given a link to a educational module that reviews chronic GI conditions, pathophysiology, and alternative treatment options.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Controlled studies indicate that hypnotherapy is effective in treating conditions like irritable bowel syndrome and peptic ulceration, suggesting it can be a valuable therapeutic option in gastroenterology.

There is emerging evidence that hypnotherapy may also impact certain physiological functions, warranting further research to clarify its role and mechanisms in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of hypnotherapy in gastrointestinal disease. Whorwell, PJ.[2007]

A pilot trial involving 37 adults with Crohn's disease showed that virtually delivered gut-directed hypnotherapy is an acceptable treatment option, with 73% of participants reporting high satisfaction despite some technical issues.

The study highlighted challenges in recruitment and objective data collection, indicating that future trials will need broader recruitment strategies and more funding to effectively gather comprehensive data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual adjunctive gut-directed hypnotherapy for people with Crohn's disease: A randomized controlled pilot and feasibility trial. Lores, T., Evans, S., Chur-Hansen, A., et al.[2023]

Gut-directed hypnotherapy was found to be significantly more effective than a symptom monitoring control in treating irritable bowel syndrome (IBS), with a notable improvement in primary IBS symptoms such as abdominal pain, constipation, and flatulence among 11 participants.

The treatment also led to significant reductions in anxiety levels, and the benefits were maintained at a 2-month follow-up, suggesting that hypnotherapy could be a valuable long-term intervention for IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of irritable bowel syndrome with hypnotherapy. Galovski, TE., Blanchard, EB.[2019]

Hypnotherapy has shown promise in improving symptoms and coping mechanisms for patients with gastrointestinal disorders, particularly in cases of severe irritable bowel syndrome and relapsing duodenal ulcers.

Recent controlled trials support the efficacy of hypnotherapy in these conditions, indicating that it can be a beneficial treatment option for patients who do not respond to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of hypnotherapy in gastrointestinal disorders. Francis, CY., Houghton, LA.[2019]

In a study of 448 patients with refractory irritable bowel syndrome (IBS), 76.3% experienced significant improvement in symptoms after gut-directed hypnotherapy, indicating its efficacy as a treatment option.

Patients with higher baseline non-colonic symptom scores and lower anxiety and depression levels were more likely to respond positively to hypnotherapy, suggesting that assessing these characteristics can help identify those who will benefit most from this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial: predictive factors for response to gut-directed hypnotherapy for refractory irritable bowel syndrome, a post hoc analysis. Devenney, J., Hasan, SS., Morris, J., et al.[2023]

Hypnotherapy has been shown to significantly improve gastrointestinal symptoms in both adults and children with irritable bowel syndrome (IBS), with 7 out of 10 randomized controlled trials in adults reporting superior outcomes compared to control groups.

While the evidence for hypnotherapy's effectiveness in other gastrointestinal disorders is limited, preliminary studies suggest potential benefits for conditions like functional dyspepsia and ulcerative colitis, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypnosis Treatment of Gastrointestinal Disorders: A Comprehensive Review of the Empirical Evidence. Palsson, OS.[2022]

Gut-directed hypnotherapy has been shown to significantly reduce gastrointestinal symptoms in patients with irritable bowel syndrome (IBS), with response rates ranging from 24% to 73% and long-term efficacy maintained in several studies.

The technique may also help maintain clinical remission in patients with ulcerative colitis, but more research is needed to determine its role as a primary or adjunctive therapy and to address gaps in understanding its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review article: gut-directed hypnotherapy in the management of irritable bowel syndrome and inflammatory bowel disease. Peters, SL., Muir, JG., Gibson, PR.[2022]

Gut-directed hypnotherapy (HT) was found to be effective in treating children aged 8-18 with functional abdominal pain (FAP) and irritable bowel syndrome (IBS), as evidenced by a significant decrease in rectal hypersensitivity in the HT group compared to standard medical therapy (SMT).

However, the improvement in clinical symptoms from HT was not linked to changes in rectal sensitivity, indicating that the mechanisms behind HT's effectiveness in alleviating abdominal pain remain unclear and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No change in rectal sensitivity after gut-directed hypnotherapy in children with functional abdominal pain or irritable bowel syndrome. Vlieger, AM., van den Berg, MM., Menko-Frankenhuis, C., et al.[2010]

Gut-directed hypnotherapy (HT) showed long-lasting benefits for children with functional abdominal pain (FAP) and irritable bowel syndrome (IBS), with 68% of participants in remission after an average follow-up of 4.8 years, compared to only 20% in the standard medical treatment group.

Participants in the HT group reported significantly lower pain intensity and frequency scores compared to those receiving standard medical treatment, indicating that HT is a highly effective and valuable therapeutic option for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of gut-directed hypnotherapy vs. standard care in children with functional abdominal pain or irritable bowel syndrome. Vlieger, AM., Rutten, JM., Govers, AM., et al.[2015]

Gut-directed hypnotherapy (GHT) has shown promise in improving health-related quality of life and reducing symptoms in patients with inflammatory bowel diseases (IBD), which are chronic conditions with no known cure.

GHT may also have an immune-modulating effect, potentially enhancing clinical remission in patients with quiescent ulcerative colitis, suggesting it could be a beneficial complementary treatment for managing IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of hypnotherapy for the treatment of inflammatory bowel diseases. Moser, G.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6850508/

Gut‐focused hypnotherapy for Functional Gastrointestinal ... This approach resulted in a clinically significant reduction in IBS symptoms in 65% of twenty IBS patients treated with 12 sessions of hypnotherapy which ...

2. jnmjournal.org jnmjournal.org/journal/view.html?doi=10.5056/jnm.20.2.152

A Systematic Review and Meta-analysis This study provides clearer evidence that hypnotherapy has beneficial short-term effects in improving gastrointestinal symptoms of patients with IBS. Keywords: ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06890663

Telehealth-Delivered Gut-Directed Hypnotherapy for ... This study aims to evaluate the specific and non-specific effects of hypnotherapy and to evaluate the efficacy of group-format gut-directed hypnotherapy (GDH) ...

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1389911/full

Gut-directed hypnosis and hypnotherapy for irritable bowel ... At the end of therapy, hypnosis was superior to control conditions in producing symptom relief (Relative Risk [RR], 1.69; 95% Confidence ...

5. cghjournal.org cghjournal.org/article/S1542-3565(23)00500-1/fulltext

A Randomized Parallel-group Study of Digital Gut-directed ... Treatment with a digital GDH program led to an improvement in abdominal pain and stool symptoms in patients with IBS, supporting a role for this intervention.

6. withpower.com withpower.com/trial/phase-gastrointestinal-irritation-1-2025-a3f2a

Hypnotherapy for Gastrointestinal Irritation Research shows that hypnotherapy has been used safely for various gastrointestinal disorders, including irritable bowel syndrome and inflammatory bowel diseases ...

7. researchgate.net researchgate.net/publication/263390129_Efficacy_Tolerability_and_Safety_of_Hypnosis_in_Adult_Irritable_Bowel_Syndrome_Systematic_Review_and_Meta-Analysis

(PDF) Efficacy, Tolerability, and Safety of Hypnosis in Adult ... Conclusion: This meta-analysis demonstrated that hypnosis was safe and provided long-term adequate symptom relief in 54% of patients with ...