Guided self-help for women with chronic pelvic pain (CPP) in primary care
ISRCTN | ISRCTN95540596 |
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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
Scientific
School of Nursing, Midwifery and Social Work
Oxford Road
Manchester
M13 9PL
United Kingdom
Phone | +44 161 275 7583 |
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diane.escott@manchester.ac.uk |
Study information
Study design | Single-centre randomised interventional treatment trial |
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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 |
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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
M13 9PL
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
School of Nursing, Midwifery and Social Work
Oxford Road
Manchester
M13 9PL
England
United Kingdom
Website | http://www.manchester.ac.uk/ |
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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 | |
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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