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WithdrawnNCT01562964Updated Aug 31, 2018

Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries

An interventional study of Hypnotherapy and Supportive therapy in Chest Pain and Unobstructed Coronary Arteries, sponsored by Imperial College London. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-31.

Sponsored by Imperial College London · Not applicable, Interventional, and Treatment

Why this study was withdrawn
No funding
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chest Pain
  • Unobstructed Coronary Arteries

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03

In context

Chest Pain

381 studies on the registry are indexed under Chest Pain; 66 are open to participants now.

Browse Chest Pain studies →

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralHypnotherapy

    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.

  • BehavioralSupportive 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.

06

What researchers measure

Primary outcomes

  1. Symptom frequency

    Time frame: 24 weeks

Secondary outcomes

  1. Symptom severity

    Time frame: 24 weeks

  2. Psychological morbidity

    Time frame: 24 weeks

  3. General quality of life

    Using Short Form 36 questionnaire

    Time frame: 24 weeks

  4. Hospitalisations

    Time frame: 24 weeks

  5. Consultancy time

    Time frame: 24 weeks

  6. Medication use

    Time frame: 24 weeks

07

Study locations

1 site
  • Royal Brompton & Harefield NHS Foundation Trust
    London, SW3 6NP, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01562964
Lead sponsor
Imperial College London
Responsible party
Sponsor
First posted
Mar 26, 2012
Start date
Feb 1, 2012
Primary completion
Mar 2, 2012
Completion
Mar 2, 2012
Last update
Aug 31, 2018

Study contacts

Peter Collins, MD, FRCP
principal investigator · Imperial College London, and Royal Brompton & Harefield NHS Foundation Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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