Condition category
Urological and Genital Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
11/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A Doshani

ORCID ID

Contact details

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0123173227

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

The difference in STAI score between women in the intervention and control group.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/09/2005

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

150 questionnaires will be given to all women attending the urodynamics clinic.

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

150

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

16/09/2005

Recruitment end date

01/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University Hospitals of Leicester NHS Trust (UK), Department Research Funds

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

1. 2009 scoping study in http://www.ncbi.nlm.nih.gov/pubmed/19191280

Publication citations

  1. Scoping study

    Doshani A, Mayne C, Tincello D, Anxiety among women attending urodynamic investigation: scoping study for a randomized trial of psychometric intervention., Neurourol. Urodyn., 2009, 28, 3, 177-178, doi: 10.1002/nau.20660.

Additional files

Editorial Notes