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

Trial Summary

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 data supports the effectiveness of the treatment hypnotherapy for gastrointestinal irritation?

Research shows that hypnotherapy is effective in improving symptoms for people with irritable bowel syndrome (IBS), a common gastrointestinal disorder. Studies have found that both adults and children with IBS experience significant relief from symptoms like abdominal pain and constipation after hypnotherapy, with benefits lasting over time. ^{1 2 3 4 5}

Is hypnotherapy safe for treating gastrointestinal issues?

Research shows that hypnotherapy has been used safely for various gastrointestinal disorders, including irritable bowel syndrome and inflammatory bowel diseases. Studies indicate it can improve symptoms and quality of life without significant safety concerns. ^{3 6 7 8 9}

How does hypnotherapy differ from other treatments for gastrointestinal irritation?

Hypnotherapy is unique because it uses guided relaxation and focused attention to help manage gastrointestinal symptoms, unlike traditional medical treatments that often rely on medication. It has shown significant improvement in conditions like irritable bowel syndrome by modulating gut function and altering how the brain processes gut-related sensory signals, offering relief for patients who do not respond well to standard treatments. ^{1 3 5 6 10}

What is the purpose of this trial?

The purpose of this research is to evaluate if hypnotherapy delivered digitally will help your GI symptoms.

Research Team

Xiao Jing (Iris) Wang, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 (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]

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 (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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of hypnotherapy in gastrointestinal disorders. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

The treatment of irritable bowel syndrome with hypnotherapy. [2019]

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

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

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

Clinical trial: predictive factors for response to gut-directed hypnotherapy for refractory irritable bowel syndrome, a post hoc analysis. [2023]

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

No change in rectal sensitivity after gut-directed hypnotherapy in children with functional abdominal pain or irritable bowel syndrome. [2010]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Use of hypnotherapy in gastrointestinal disease. [2007]

8. England pubmed.ncbi.nlm.nih.gov

Virtual adjunctive gut-directed hypnotherapy for people with Crohn's disease: A randomized controlled pilot and feasibility trial. [2023]

9. United States 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. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Review article: gut-directed hypnotherapy in the management of irritable bowel syndrome and inflammatory bowel disease. [2022]