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
+44 161 275 7583
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 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 trial start date
01/11/2010
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list