Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
17/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Robert Lewin

ORCID ID

Contact details

Department of Health Sciences
University of York
Genesis 6
York Science Park
York
YO10 5DQ
United Kingdom
+44 (0)1904 434106
rjpl1@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RM103

Study information

Scientific title

Acronym

Study hypothesis

To determine if an advice and relaxation tape given to patients within 12 hours of admission to hospital with acute myocardial infarction would reduce anxiety and depression and lead to improved cardiac knowledge and rehabilitative outcomes.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular diseases: Heart disease

Intervention

1. A specially developed audiocassette with relaxation instruction and advice and information - to be listened to as often as the patient wished and taken home on discharge.
2. An audio cassette of music chosen by the patient from a selection of different musical genres.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Coronary risk factors
1.1. body mass index
1.2. smoking
1.3. behaviour
1.4. cholesterol
1.5. blood pressure
2. Physiological status
2.1. heart rate
2.2. blood pressure
3. Psychological status
3.1. anxiety
1.2. depression
4. Cardiac misconceptions

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1997

Overall trial end date

01/03/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Patients admitted to a coronary care ward with acute MI.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

243 (added 17/07/09)

Participant exclusion criteria

Patients regarded by medical staff in the CCU as being too ill to take part in the trial.

Recruitment start date

01/10/1997

Recruitment end date

01/03/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Health Sciences
York
YO10 5DQ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11853894

Publication citations

  1. Results

    Lewin RJ, Thompson DR, Elton RA, Trial of the effects of an advice and relaxation tape given within the first 24 h of admission to hospital with acute myocardial infarction., Int. J. Cardiol., 2002, 82, 2, 107-14; discussion 115-6.

Additional files

Editorial Notes