Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study

Stopped early · Not applicable

Conditions studied: Functional Chest Pain

In brief

The primary aim is to develop and test the feasibility of a standardized digital audio home-hypnotherapy (HHT) program for patients with refractory functional chest pain (FCP). The secondary aims of this study are: 1. To obtain pilot data to assess the magnitude of the treatment effect of self-hypnosis in refractory FCP for an anticipated future, larger treatment trial; 2. To determine the stability of the treatment effect of HHT in refractory FCP; 3. To assess the relationship between response to HHT and psychological factors; and 4. To assess the relationship between response to HHT and symptomatic dimensions of chest pain (severity, frequency, and duration). 5. To assess the difference

Key facts

Study ID

NCT01284179

Run by

University of North Carolina, Chapel Hill

People needed

8

Starts

2011-02-01

Expected to finish

2015-12-01

Last updated by the study team

2016-12-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 80, male or female.
• Patients must fulfill the Rome III criteria for Functional Chest Pain of Presumed Esophageal Origin for the previous 3 months (with symptom onset at least 6 months before diagnosis), including all of the following:
• Midline chest pain or discomfort that is not of burning quality
• Absence of evidence that gastroesophageal reflux is the cause of the symptom
• Absence of histopathology-based esophageal motility disorders
• Persistent symptoms despite a trial of antidepressant therapy, as defined by either:
• chest pain despite at least a continuous 4-week trial of at least one antidepressant within the last 6 months; or
• intolerance of at least one antidepressant within the last 6 months.
• Negative cardiac evaluation (negative cardiac stress test or negative coronary angiogram)
• Negative gastrointestinal evaluation for cause of the pain, defined by absence of Los Angeles grade C or D erosive esophagitis on endoscopy, persistent chest pain on PPI therapy, and no association of chest pain with reflux episodes on an ambulatory pH or pH-impedance study, defined as a symptom index <50% or symptom association probability <95% for chest pain .

You may not qualify if…

• Severe co-morbid illness (cardiac, pulmonary, renal, hematologic, hepatic)
• Prior treatment with hypnosis/hypnotherapy for a medical condition
• Prior major thoracic surgery
• Prior diagnosis of or treatment for dissociative disorders, post-traumatic stress disorder, borderline personality disorder, or other psychiatric disorders that include psychotic features
• Pregnancy or planned pregnancy within the upcoming 3 months
• Inability or unwillingness to give informed consent

Where it is running

• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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