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 designSingle-centre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn exploratory randomised controlled trial of guided self-help for women with chronic pelvic pain (CPP) in primary care
Study acronymSUPPORT
Study objectivesThis 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) studiedTopic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
InterventionThis 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 typeOther
Primary outcome measureReduction in pain and symptom severity, measured at 6 months and 12 months
Secondary outcome measures1. 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 date01/11/2010
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsPlanned sample size: 140
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/2010
Date of final enrolment31/12/2011

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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