ISRCTN ISRCTN54865517
DOI https://doi.org/10.1186/ISRCTN54865517
Protocol serial number RDO/22/33
Sponsor Department of Health (UK)
Funder Department of Health (UK) - NHS Exec Biomedical Funding Scheme (ref: RDO/22/33)
Submission date
30/08/2005
Registration date
07/09/2005
Last edited
26/05/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Peter Whorwell
Scientific

Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom

Phone +44 (0)1612915813
Email peter.whorwell@smuht.nwest.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo assess whether hypnotherapy has a role in the treatment of non cardiac chest pain
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNon cardiac chest pain
InterventionPatients will be randomised to receive either:
1. 12 sessions of Hypnotherapy
or:
2. 12 sessions of supportive listening of equal duration to hypnotherapy plus placebo medication
Intervention typeOther
Primary outcome measure(s)

Subjective global assessment of relief of symptoms compared with pre-trial status.

Key secondary outcome measure(s)

To determine whether hypnotherapy improves frequency, severity and duration of non cardiac chest pain, as well as quality of life and psychological status (visual analogue scales).

Completion date01/09/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration50
Key inclusion criteriaPatients with angina-like chest pain who have been shown to have normal coronary arteries and have no other co-existent disease.
Key exclusion criteria1.Patients with proven coronary artery disease
2.Patients with oesophageal reflux disease
Date of first enrolment01/01/2002
Date of final enrolment01/09/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2006 Yes No
Other publications resullts 01/11/2007 Yes No