Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries

Not Applicable

Withdrawn

• Conditions: Unobstructed Coronary Arteries; Chest Pain
• Interventions: Behavioral: Supportive therapy; Behavioral: Hypnotherapy

• Registration Number: NCT01562964
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-01
• Primary Completion: 2012-03-02
• Study Completion: 2012-03-02
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-26
• Status Verified: 2015-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive therapy	Supportive therapy	Subjects in the Supportive therapy group will attend the Royal Brompton Hospital weekly for 10 weeks to meet with person of equal status to the hypnotherapist (e.g. a research assistant, not a medical practitioner) trained to provide counseling and support. Visits will last 50-60 min. Patients will be encouraged to talk about their physical symptoms and any emotional issues, and to discuss how these might be coped with in a better way.
Hypnotherapy	Hypnotherapy	Hypnotherapy will be conducted at the Royal Brompton Hospital by a qualified practician (DF). Ten pain control hypnotherapy session will run for 50-60 minutes each. In the first session a thorough history will be taken of the patient's chest pain history together with both the sensory and affective components of their pain. If there is time, relaxation technique and self-hypnosis will be taught at this visit. In subsequent sessions, various techniques, including techniques that focus on direct suggestions and imagery work, will be applied and taught to the patient. The pain control techniques are all analgesic in nature - focusing on the reduction, but not the total removal of the pain. A small amount of pain is left behind to serve as a reminder that either something is wrong or that the patient needs to take it easy.

Primary Outcome Measures

Name	Time	Method
Symptom frequency	24 weeks

Secondary Outcome Measures

Name	Time	Method
General quality of life	24 weeks	Using Short Form 36 questionnaire
Hospitalisations	24 weeks
Symptom severity	24 weeks
Psychological morbidity	24 weeks
Consultancy time	24 weeks
Medication use	24 weeks

Trial Locations

Locations (1)

Royal Brompton & Harefield NHS Foundation Trust; 🇬🇧 London, United Kingdom