Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT05572606
The purpose of this research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 6 weeks, 12 weeks, and 3 months
Measured on a 0-100 scale using the bloating severity question of the the validated Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Time frame: Baseline, 6 weeks, 12 weeks, and 3 months
Assessed using the well validated upper GI symptom Severity Index (PAGI-SYM)
Time frame: Baseline, 6 weeks, 12 weeks, and 3 months
Measured using the self-reported Visceral Sensitivity Index (VSI)
Time frame: Baseline, 6 weeks, 12 weeks, and 3 months
Assessed via the self-reported EuroQol-5D-5L (EQ-5D-5L) to evaluate mobility, self-care, usual activity, pain/discomfort, and anxiety/depression
Time frame: Baseline, 12 weeks, and 3 months
Assessing the number of outpatient visits, portal messages, and procedures generated in three months
Mayo Clinic
Other
Development and Delivery of a Novel Hypnotherapy Protocol for Treatment of Symptomatic Bloating
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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