Psychosexual factors and well-being in women receiving a specialist ultrasound scan

ISRCTN	ISRCTN97337545
DOI	https://doi.org/10.1186/ISRCTN97337545
Secondary identifying numbers	N0047111222

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 27/11/2015

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 of protocol

Not provided at time of registration

Contact information

Dr Mark Kilby
Scientific

Birmingham Women's Hospital
Edgbaston
Birmingham
Birmingham
B15 2TG
United Kingdom

Phone	+44 0121 627 2777
Email	m.d.kilby@bham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Scientific title	Psychosexual factors and well-being in women receiving a specialist ultrasound scan
Study objectives	How do different ways of providing information about a specialist ultrasound scan (interview, letter, audiotape, and a combination of these) affect accuracy of recall and psychological wellbeing in pregnant women?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Psychological wellbeing in pregnant women
Intervention	Randomised controlled trial. All women attending the clinic for a specialist scan will be invited to participate in the study. They will be provided with an information sheet outlining the details of the study. Women agreeing to participate will complete a questionnaire before their scan. Participants will be randomly assigned to one of four experimental groups using a pre-arranged randomised schedule. These groups will comprise: 1. A control group - receiving the standard care package of an interview and copy of the scan report 2. In addition to the above, group two will receive an audiotaped copy of the interview 3. In addition to the standard care package of an interview and copy of the scan report, group three will be sent a written summary of their interview 4. In addition to the standard care package, group four will receive both a taped copy of the interview and will be sent a written summary.
Intervention type	Other
Primary outcome measure	1. State anxiety measured using the self-report State-Trait Anxiety Inventory (STAI) at baseline and 2 weeks post scan 2. Depression measured using the Beck Depression Inventory (BDI) at baseline and 2 weeks post scan
Secondary outcome measures	Information recall measured using a structured telephone interview 2 weeks post scan.
Overall study start date	04/05/2000
Completion date	30/06/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	550
Key inclusion criteria	Women with congenital abnormalities of their babies.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	04/05/2000
Date of final enrolment	30/06/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Birmingham Women's Hospital

Birmingham
B15 2TG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Birmingham Women's Healthcare NHS Trust

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	30/12/2003		Yes	No

Editorial Notes

27/11/2015: Publication reference and outcome measures added.