Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries

NCT01562964 | Withdrawn

• 1 other identifier: P40285
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain; Unobstructed Coronary Arteries

Outcome Measures

Primary Outcomes (1)

• Symptom frequency

  24 weeks

Secondary Outcomes (6)

• Symptom severity

  24 weeks

• Psychological morbidity

  24 weeks

• General quality of life

  24 weeks

• Hospitalisations

  24 weeks

• Consultancy time

  24 weeks

Study Arms (2)

Hypnotherapy

EXPERIMENTAL

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

Supportive therapy

ACTIVE COMPARATOR

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

Interventions

Hypnotherapy BEHAVIORAL

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.

Hypnotherapy

Supportive therapy BEHAVIORAL

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.

Supportive therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• history of chest pain for ≥ 2 years
• ≥ 2 episodes chest pain per week
• angiographically smooth epicardial coronary arteries
• Willing to give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Royal Brompton & Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Chest Pain

Interventions

Hypnosis; Palliative Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Peter Collins, MD, FRCP

  Imperial College London, and Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: February 1, 2012
• Primary Completion: March 2, 2012
• Study Completion: March 2, 2012
• Last Updated: August 31, 2018

Record last verified: 2015-08

Locations

GB (1)