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
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
-
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.