Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chest Pain Unobstructed Coronary Arteries |
Behavioral: Hypnotherapy Behavioral: Supportive therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Impact of Hypnotherapy on Symptoms, Psychological Morbidity and Quality of Life in Postmenopausal Women With Chest Pain and Unobstructed Coronary Arteries |
- Symptom frequency [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Symptom severity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Psychological morbidity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Hospitalisations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Consultancy time [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Medication use [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 42 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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.
|
Behavioral: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Carolyn M. Webb, PhD | c.webb@imperial.ac.uk |
| United Kingdom | |
| Royal Brompton & Harefield NHS Foundation Trust | Not yet recruiting |
| London, United Kingdom, SW3 6NP | |
| Principal Investigator: Peter Collins, MD, FRCP | |
| Principal Investigator: | Peter Collins, MD, FRCP | Imperial College London, and Royal Brompton & Harefield NHS Foundation Trust |
More Information
No publications provided
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01562964 History of Changes |
| Other Study ID Numbers: | P40285 |
| Study First Received: | March 22, 2012 |
| Last Updated: | March 23, 2012 |
| Health Authority: | United Kingdom: Department of Health |
Additional relevant MeSH terms:
|
Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013