| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN54376052 |
| Date ISRCTN assigned | 17/10/2002 |
| Local reference number(s) | HTA 99/48/04 |
| Public title | Amniocentesis Results: Investigation of Anxiety |
| Scientific title |
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| Acronym | ARIA |
| Disease/condition/study domain | Pregnancy |
| Study hypothesis | 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. |
| Design/methodology | 2 X 2 factorial design randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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 |
| Participants - exclusion criteria | 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. |
| Patient information material |
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| Anticipated start date | 01/09/2001 |
| Anticipated end date | 31/03/2005 |
| Status of trial | Completed |
| Target number of participants | 226 |
| Interventions | 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.
Interventions:
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. |
| Primary outcome measure(s) | 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. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Trial website | http://www.leeds.ac.uk/medicine/psychiatry/research/aria.htm |
| Publications | HTA monograph published, see http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17134598 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Department of Health (UK) |
| Sponsor details | Quarry House
Quarry Hill
Leeds
United Kingdom
LS2 7UE |
| Sponsor email | Sheila.Greener@doh.gsi.gov.uk |
| Sponsor website | http://www.dh.gov.uk/en/index.htm |
| Contact name | Prof Jenny Hewison |
| Contact details | Academic Department of Psychiatry and Behavioural Sciences
University of Leeds
15 Hyde Terrace
Leeds
United Kingdom
LS2 9LT |
| Contact telephone | +44 (0)113 343 1894 |
| Contact fax | +44 (0)113 243 3719 |
| Contact email | j.hewison@leeds.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN54376052 |
| Date last extracted from ISRCTN register | 17/04/2008 |
