Psychosexual factors and well-being in women receiving a specialist ultrasound scan
| ISRCTN | ISRCTN97337545 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97337545 |
| Protocol serial number | N0047111222 |
| Sponsor | Department of Health (UK) |
| Funder | Birmingham Women's Healthcare NHS Trust |
- 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
Scientific
Birmingham Women's Hospital
Edgbaston
Birmingham
Birmingham
B15 2TG
United Kingdom
| Phone | +44 0121 627 2777 |
|---|---|
| m.d.kilby@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. State anxiety measured using the self-report State-Trait Anxiety Inventory (STAI) at baseline and 2 weeks post scan |
| Key secondary outcome measure(s) |
Information recall measured using a structured telephone interview 2 weeks post scan. |
| Completion date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Birmingham Women's Hospital
Birmingham
B15 2TG
United Kingdom
B15 2TG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
