Evaluating the benefits of an advice and relaxation tape given during acute myocardial infarction (MI).
| ISRCTN | ISRCTN47514125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47514125 |
| Secondary identifying numbers | RM103 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 17/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Robert Lewin
Scientific
Scientific
Department of Health Sciences
University of York
Genesis 6
York Science Park
York
YO10 5DQ
United Kingdom
| Phone | +44 (0)1904 434106 |
|---|---|
| rjpl1@york.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/1997 |
| Completion date | 01/03/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 243 (added 17/07/09) |
| Key inclusion criteria | Patients admitted to a coronary care ward with acute MI. |
| Key exclusion criteria | Patients regarded by medical staff in the CCU as being too ill to take part in the trial. |
| Date of first enrolment | 01/10/1997 |
| Date of final enrolment | 01/03/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Health Sciences
York
YO10 5DQ
United Kingdom
YO10 5DQ
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2002 | Yes | No |
