Reduction of anxiety before urodynamics: a randomised trial of pre-test education
| ISRCTN | ISRCTN11404346 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11404346 |
| Protocol serial number | N0123173227 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | University Hospitals of Leicester NHS Trust (UK), Department Research Funds |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 20/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A Doshani
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | - |
| Study objectives | The study aims to compare between the effect of written information and a guided tour on anxiety levels in women attending the urodynamic clinics. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases |
| Intervention | Randomised controlled trial. Clinical Study, Human Physiology, Inpatient Admission, Multicentre Study: National, NHS Patients, Study of Non-Therapeutic Procedure. Written information and a guided tour vs standard practice. |
| Intervention type | Other |
| Primary outcome measure(s) |
The difference in STAI score between women in the intervention and control group. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 150 |
| Key inclusion criteria | 150 questionnaires will be given to all women attending the urodynamics clinic. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 16/09/2005 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
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? |
|---|---|---|---|---|---|
| Other publications | scoping study | 01/12/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/02/2020: No results publications found, all search options exhausted, study status unverified.
