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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01562964
Other study ID # P40285
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 1, 2012
Est. completion date March 2, 2012

Study information

Verified date August 2015
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2, 2012
Est. primary completion date March 2, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Hypnotherapy
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.
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.

Locations

Country Name City State
United Kingdom Royal Brompton & Harefield NHS Foundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Symptom frequency 24 weeks
Secondary Symptom severity 24 weeks
Secondary Psychological morbidity 24 weeks
Secondary General quality of life Using Short Form 36 questionnaire 24 weeks
Secondary Hospitalisations 24 weeks
Secondary Consultancy time 24 weeks
Secondary Medication use 24 weeks
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