Guided self-help for women with chronic pelvic pain (CPP) in primary care

ISRCTN	ISRCTN95540596
DOI	https://doi.org/10.1186/ISRCTN95540596
Secondary identifying numbers	8336

Submission date: 21/10/2010
Registration date: 21/10/2010
Last edited: 11/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

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 Diane Escott
Scientific

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

Phone	+44 161 275 7583
Email	diane.escott@manchester.ac.uk

Study information

Study design	Single-centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	An exploratory randomised controlled trial of guided self-help for women with chronic pelvic pain (CPP) in primary care
Study acronym	SUPPORT
Study objectives	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(s)	Northwest 2 Liverpool Central REC, 04/05/2010, ref: 10/H1005/24
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2010
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned sample size: 140
Key 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
Key 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
Date of first enrolment	01/11/2010
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Nursing, Midwifery and Social Work

Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

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

Website	http://www.manchester.ac.uk/
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Government

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

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

Editorial Notes

11/05/2017: No publications found in PubMed, verifying study status with principal investigator