Condition category
Signs and Symptoms
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
01/09/2014
Prospective/Retrospective
Prospectively 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 Diane Escott

ORCID ID

Contact details

School of Nursing
Midwifery and Social Work
Oxford Road
Manchester
M13 9PL
United Kingdom
diane.escott@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8336

Study information

Scientific title

An exploratory randomised controlled trial of guided self-help for women with chronic pelvic pain (CPP) in primary care

Acronym

SUPPORT

Study hypothesis

This is a pilot trial of an evidence-based self-care guide for women with chronic pelvic pain that will be facilitated by their GP. The trial aims to assess the effects of the guide on: pain and symptom severity; psychological wellbeing (anxiety and depression); health-related quality of life; self-efficacy; sexual relationships; work life; use of healthcare services. Participating GPs will receive training to use the guide within their consultations. Women will be randomised to either receive the facilitated self-care guide or usual care.

Ethics approval

Northwest 2 Liverpool Central REC, 04/05/2010, ref: 10/H1005/24

Study design

Single-centre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

This is a pilot trial of an evidence-based self-care guide for women with CPP that will be facilitated by their GP.

The guide contains information about chronic pelvic pain, what it is, how it presents, possible causes, and potential treatment and management strategies. Assessment, investigations and common diagnoses are explained. A specific section of the guide addresses the possibility that no diagnosis will be found to account for the woman's pain. The guide provides advice on pain management, lifestyle and social factors and coping with psychological distress. The guide uses positive language and encourages partnership between the woman and her GP.

Delivery of the intervention:
Group 1: women in Group 1 will receive the self-help guide from their GP. The GP will facilitate the guide in a consultation, focussing on issues which the patient identifies as priority areas.
Group 2: patients allocated to Group 2 will continue to receive their routine care as defined by their GP.

Assessments - timing and administration:
Women who consent to participate in the trial will have data collected on entry to the trial, at 6 months and 1 year later. Initial data collection (baseline and 6 months) will be conducted pre- and post-delivery of the guide. Questionnaires will be administered by post with telephone support (if required) from the Trial Coordinator. Data collection at 1 year will assess longer term outcomes.

Study entry:
Single randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Reduction in pain and symptom severity, measured at 6 months and 12 months

Secondary outcome measures

1. Health-related quality of life, measured at 6 months and 12 months
2. Psychological wellbeing (anxiety and depression), measured at 6 months and 12 months
3. Self-efficacy, measured at 6 months and 12 months
4. Sexual relationships, measured at 6 months and 12 months
5. Use of healthcare services, measured at 6 months and 12 months
6. Work life, measured at 6 months and 12 months

Overall trial start date

01/11/2010

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and above, female
2. Pelvic pain greater than 3 months duration
3. Pain not necessarily related to menstrual cycle or sexual activity
4. Has a common diagnosis which falls under the umbrella of CPP
5. Has a symptom profile attributed to CPP, in the absence of a diagnosis

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned sample size: 140

Participant exclusion criteria

1. Pregnancy or within 12 months of delivery
2. Serious underlying pathology
3. Insufficient English to engage in self-help
4. Participation in other pain management research

Recruitment start date

01/11/2010

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Nursing, Midwifery and Social Work
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

School of Nursing
Midwifery and Social Work
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-0408-16192)

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

Publication citations

Additional files

Editorial Notes