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ISRCTN
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ISRCTN54376052
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ClinicalTrials.gov identifier
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Public title
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Amniocentesis Results: Investigation of Anxiety
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Scientific title
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Acronym
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ARIA
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Serial number at source
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HTA 99/48/04
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Study hypothesis
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There is evidence both that being able to predict stressful events, and having information which normalises the content and timing of worries about such events, reduces anxiety. This provides scope for interventions designed to minimise anxiety while waiting for test results.
Phase one:
1. To identify patterns of anxiety and the factors that contribute to this.
2. To develop an appropriate intervention for phase two, the RCT. 3. To obtain information about the patterns of anxiety which will inform the outcome measures and the timing of measurement in the RCT.
Phase two - to test the following hypotheses:
1.That giving amniocentesis results out on a fixed date with an undertaking not to phone earlier even if possible, alters maternal anxiety during the waiting period, compared with a policy of phoning as soon as possible.
2. Providing parents with a "debriefing" leaflet describing the normal pattern of worry during the waiting period, reduces anxiety.
Please note that, as of 15 January 2008, the start and end dates of this trial have been updated from 1 January 2001 and 31 December 2003 to 1 September 2001 and 31 March 2005, respectively.
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Ethics approval
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Not provided at time of registration
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Study design
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2 X 2 factorial design randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Pregnancy
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Participants - inclusion criteria
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Pregnant women who are having an amniocentesis for indications such as maternal age, triple test risk or the presence of a soft marker for Downs Syndrome
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Participants - exclusion criteria
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Women with a major structural abnormality on scan. Women who miscarry before the karyotype result is obtained (<1%) or whose result indicates aneuploidy (1 in 70) will be excluded from the primary analysis.
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Anticipated start date
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01/09/2001
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Anticipated end date
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31/03/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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226
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Interventions
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Phase one: an observational cohort study (n=30) using anxiety diaries and qualitative interviews. Phase two: a 2 X 2 factorial design randomised controlled trial. Participants will be randomised immediately after amniocentesis to "phone result when available" or "issue result on a fixed date" and to "leaflet" or "no leaflet". The trial will use independent telephone randomisation, stratified by centre and maternal age (<35, >=35years). Setting: seven amniocentesis clinics = Leeds General Infirmary and St James's, Airedale, Harrogate, York, Hull Maternity Hospital and Castle Hill.
The aim is to investigate how two interventions, firstly, the issue of a standard culture result on a fixed date (18 days after amniocentesis) or variable date, secondly, how the implementation of a new cytogenetic technique, Fluorescent In-situ Hybridisation (FISH), affect maternal anxiety levels.
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Primary outcome measure(s)
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We will measure anxiety daily using the short Spielberger state measure with regular phone reminders The primary outcomes will be total anxiety in the first 24 hours after the test, over the last 24 hours before the result is issued, and the peak level of anxiety reached. Within 24 hours of issuing the results, parents will be asked to recall and score their anxiety over the waiting period. This will provide validation of the prospectively collected scores. We will not conduct any economic analysis because the costs of different modes of issuing results will be similar and the leaflets will be cheap. We will recommend that the method, which minimises anxiety, be used.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.leeds.ac.uk/medicine/psychiatry/research/aria.htm
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Publications
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2006 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/17134598
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Contact name
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Prof
Jenny
Hewison
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Address
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Academic Department of Psychiatry and Behavioural Sciences
University of Leeds
15 Hyde Terrace
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City/town
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Leeds
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Zip/Postcode
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LS2 9LT
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Country
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United Kingdom
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Tel
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+44 (0)113 343 1894
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Fax
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+44 (0)113 243 3719
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Email
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j.hewison@leeds.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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17/10/2002
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Last edited
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27/08/2009
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Date ISRCTN assigned
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17/10/2002
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