Clinical trial NCT01562964: Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries
Official title: The Impact of Hypnotherapy on Symptoms, Psychological Morbidity and Quality of Life in Postmenopausal Women With Chest Pain and Unobstructed Coronary Arteries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chest Pain
Unobstructed Coronary Arteries
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2012-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate whether clinical hypnotherapy can effectively treat chest pain symptoms, improve emotional wellbeing and quality of life in postmenopausal women with chest pain and coronary arteries without any narrowings. The diagnosis of chest pain with 'normal' coronary arteries is found in 25% of patients undergoing investigation of chest pain using coronary angiography (when dye is injected into the coronary arteries whilst xray pictures are taken), and the majority of these patients are postmenopausal women. Often there is no obvious physical cause. Despite symptoms being treated using conventional drugs, and life expectancy is not affected, many patients continue to suffer from debilitating chest pain symptoms, frequently resulting in visits to hospital, increased psychological illness and poor quality of life. The investigators are interested in finding ways of improving not only chest pain symptoms but also psychological wellbeing and quality of life in these patients. Previous studies of ours have found improvement in these patients after taking part in a support group, and using a relaxation technique called Autogenic training. Recently the investigators conducted a pilot study which showed a favourable effect of hypnotherapy on physical ability, well-being and quality of life. The investigators would now like to extend this study, performing a larger randomised, controlled trial. The investigators hypothesise that hypnotherapy will beneficially affect symptoms and quality of life in patients with cardiac Syndrome X.


Eligibility criteria: Inclusion Criteria:

* history of chest pain for ≥ 2 years
* ≥ 2 episodes chest pain per week
* angiographically smooth epicardial coronary arteries
* Willing to give written informed consent

Exclusion Criteria:

* Any epicardial coronary atheroma on angiography of the coronary arteries
* left ventricular hypertrophy or dysfunction (clinical/ECG/echo/CXR)
* previous hypnotherapy for chest pain symptoms
* participation in research project within previous 60 days
* unwilling to give written informed consent

Primary outcomes:
measure: Symptom frequency
timeFrame: 24 weeks
Secondary outcomes:
measure: Symptom severity
timeFrame: 24 weeks
measure: Psychological morbidity
timeFrame: 24 weeks
measure: General quality of life
timeFrame: 24 weeks
measure: Hospitalisations
timeFrame: 24 weeks
measure: Consultancy time
timeFrame: 24 weeks
measure: Medication use
timeFrame: 24 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Foundation Trust
Study officials:
affiliation: Imperial College London, and Royal Brompton & Harefield NHS Foundation Trust
name: Peter Collins, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: