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The purpose of this research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms.
This study consists of seven pre-recorded hypnotherapy sessions that will be digitally delivered to patients on their own electronic devices via an existing digital platform provided by metaMe Health. metaMe Health is a company specialized in the delivery of digital hypnotherapy protocols. The sessions will be delivered to patients over twelve weeks in accordance with current gut-direct hypnotherapy practice. The patients must agree to have their consent and content delivered electronically and provide periodic outcomes by completing electronic symptom questionnaires. The whole study will last for 24 weeks: the initial 12-week treatment period and then an additional 12-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnotherapy for bloating symptoms | Experimental | Subjects experiencing bloating symptoms will receive hypnotherapy delivered electronically |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnotherapy | Behavioral | Seven pre-recorded hypnotherapy sessions delivered over the course of twelve weeks via the patient's own electronic device such as a smartphone, tablet, or laptop. The length of the audio-recorded treatment sessions is expected to be approximately 40 minutes on average. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in abdominal bloating severity | Measured on a 0-100 scale using the bloating severity question of the the validated Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) | Baseline, 6 weeks, 12 weeks, and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bloating symptoms | Assessed using the well validated upper GI symptom Severity Index (PAGI-SYM) | Baseline, 6 weeks, 12 weeks, and 3 months |
| Change in perception of GI symptoms | Measured using the self-reported Visceral Sensitivity Index (VSI) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao Jing (Iris) Wang, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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|
| Baseline, 6 weeks, 12 weeks, and 3 months |
| Change in quality of life | Assessed via the self-reported EuroQol-5D-5L (EQ-5D-5L) to evaluate mobility, self-care, usual activity, pain/discomfort, and anxiety/depression | Baseline, 6 weeks, 12 weeks, and 3 months |
| Health care utilization | Assessing the number of outpatient visits, portal messages, and procedures generated in three months | Baseline, 12 weeks, and 3 months |
| D004191 |
| Behavioral Disciplines and Activities |