Condition category
Pregnancy and Childbirth
Date applied
17/10/2002
Date assigned
17/10/2002
Last edited
27/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.leeds.ac.uk/medicine/psychiatry/research/aria.htm

Contact information

Type

Scientific

Primary contact

Prof Jenny Hewison

ORCID ID

Contact details

Academic Department of Psychiatry and Behavioural Sciences
University of Leeds
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom
+44 (0)113 343 1894
j.hewison@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 99/48/04

Study information

Scientific title

Acronym

ARIA

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.

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.

Ethics approval

Not provided at time of registration

Study design

2 X 2 factorial design randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Pregnancy

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

Not provided at time of registration

Overall trial start date

01/09/2001

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

226

Participant 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.

Recruitment start date

01/09/2001

Recruitment end date

31/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Department of Psychiatry and Behavioural Sciences
Leeds
LS2 9LT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2006 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/17134598

Publication citations

  1. HTA monograph

    Hewison J, Nixon J, Fountain J, Cocks K, Jones C, Mason G, Morley S, Thornton J, Amniocentesis results: investigation of anxiety. The ARIA trial., Health Technol Assess, 2006, 10, 50, iii, ix-x, 1-78.

Additional files

Editorial Notes