Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries

Chest Pain Clinical Trial

Official title:

The Impact of Hypnotherapy on Symptoms, Psychological Morbidity and Quality of Life in Postmenopausal Women With Chest Pain and Unobstructed Coronary Arteries

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01562964
• Other study ID #: P40285
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Chest Pain
• Unobstructed Coronary Arteries

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