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Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries

Primary Purpose

Chest Pain, Unobstructed Coronary Arteries

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hypnotherapy
Supportive therapy
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Brompton & Harefield NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypnotherapy

Supportive therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Symptom frequency

Secondary Outcome Measures

Symptom severity
Psychological morbidity
General quality of life
Using Short Form 36 questionnaire
Hospitalisations
Consultancy time
Medication use

Full Information

First Posted
March 22, 2012
Last Updated
August 29, 2018
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT01562964
Brief Title
Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries
Official Title
The Impact of Hypnotherapy on Symptoms, Psychological Morbidity and Quality of Life in Postmenopausal Women With Chest Pain and Unobstructed Coronary Arteries
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
February 1, 2012 (Actual)
Primary Completion Date
March 2, 2012 (Actual)
Study Completion Date
March 2, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Unobstructed Coronary Arteries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Supportive therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hypnotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supportive therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom frequency
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Symptom severity
Time Frame
24 weeks
Title
Psychological morbidity
Time Frame
24 weeks
Title
General quality of life
Description
Using Short Form 36 questionnaire
Time Frame
24 weeks
Title
Hospitalisations
Time Frame
24 weeks
Title
Consultancy time
Time Frame
24 weeks
Title
Medication use
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Collins, MD, FRCP
Organizational Affiliation
Imperial College London, and Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton & Harefield NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

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Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries

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