Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2012 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01562964
First received: March 22, 2012
Last updated: March 23, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Symptom frequency [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562964

Contacts
Contact: Carolyn M. Webb, PhD c.webb@imperial.ac.uk

Locations
United Kingdom
Royal Brompton & Harefield NHS Foundation Trust Not yet recruiting
London, United Kingdom, SW3 6NP
Principal Investigator: Peter Collins, MD, FRCP         
Sponsors and Collaborators
Imperial College London
Investigators
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 October 23, 2014