Amniocentesis Results: Investigation of Anxiety

ISRCTN	ISRCTN54376052
DOI	https://doi.org/10.1186/ISRCTN54376052
Secondary identifying numbers	HTA 99/48/04

Submission date: 17/10/2002
Registration date: 17/10/2002
Last edited: 08/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Prof Jenny Hewison
Scientific

Academic Department of Psychiatry and Behavioural Sciences
University of Leeds
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom

Phone	+44 (0)113 343 1894
Email	j.hewison@leeds.ac.uk

Study information

Study design	2 X 2 factorial design randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Amniocentesis Results: Investigation of Anxiety
Study 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(s)	Not provided at time of registration
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
Primary outcome measure	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 study start date	01/09/2001
Overall study end date	31/03/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	226
Total final enrolment	226
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 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

England
United Kingdom

Study participating centre

Academic Department of Psychiatry and Behavioural Sciences

Leeds
LS2 9LT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2006		Yes	No
Results article	results	01/04/2007	08/08/2019	Yes	No

Editorial Notes

08/08/2019: Publication reference and total final enrolment added.