Condition category
Signs and Symptoms
Date applied
25/10/2006
Date assigned
20/11/2006
Last edited
02/08/2007
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 Keith Petrie

ORCID ID

Contact details

Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland
1001
New Zealand
kj.petrie@auckland.ac.nz

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Providing information about normal findings prior to a exercise stress test will improve reassurance and reduce anxiety about symptoms following the investigation in patients with a negative test result.

Ethics approval

Approved by New Zealand Ministry of Health Ethics Committee (ref AKY/04/05/121) on 21 May, 2004.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Symptoms of chest pain

Intervention

Group one: standard information.
Group two: a pamphlet explaining the function and meaning of negative results from the test.
Group three: the pamphlet and a brief discussion about what normal results of the test mean.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Patients’ reported reassurance.
2. Levels of worry about their health and belief that something is seriously wrong with their heart, measured immediately following the test and at one month following testing.

Secondary outcome measures

Complaints of chest pain and whether continuing to take cardiac medication.

Overall trial start date

01/06/2004

Overall trial end date

31/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients referred for exercise stress test with negative findings

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

90

Participant exclusion criteria

1. Aged less than 18 years
2. Previously diagnosed cardiac pathology
3. No symptoms of chest pain
4. Undertaking the stress exercise test as part of a pre-surgical medical examination
5. Positive exercise stress test

Recruitment start date

01/06/2004

Recruitment end date

31/10/2004

Locations

Countries of recruitment

New Zealand

Trial participating centre

Department of Psychological Medicine
Auckland
1001
New Zealand

Sponsor information

Organisation

University of Auckland (New Zealand)

Sponsor details

Private Bag 92019
Auckland
1001
New Zealand
kj.petrie@auckland.ac.nz

Sponsor type

University/education

Website

http://www.auckland.ac.nz/

Funders

Funder type

University/education

Funder name

University of Auckland (New Zealand)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

New Zealand

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

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17259186

Publication citations

  1. Results

    Petrie KJ, Müller JT, Schirmbeck F, Donkin L, Broadbent E, Ellis CJ, Gamble G, Rief W, Effect of providing information about normal test results on patients' reassurance: randomised controlled trial., BMJ, 2007, 334, 7589, 352, doi: 10.1136/bmj.39093.464190.55.

Additional files

Editorial Notes