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Pelvic Pain Connect study: a co-designed pre-pilot study to evaluate an interdisciplinary model of care for women with pelvic pain in a regional setting

Royal Women’s Hospital – Northeast Health Wangaratta Pelvic Pain Connect study: a co-designed pre-pilot study to evaluate an interdisciplinary model of care for women with pelvic pain in a regional setting.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000369325
Enrollment
6
Registered
2026-03-24
Start date
2026-03-30
Completion date
2026-06-30
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Pelvic pain is common, affecting about one in four women, typically starting in their teenage and young adult lives, critical times while they are studying, entering the workforce, developing relationships and considering a family, with pain continuing right up to menopause and beyond. The burden on the individual affects their physical and mental health, in turn affecting their work, study and relationships. Women living outside metropolitan areas usually experience significant barriers to access the specialised and interdisciplinary care they need. This study will design, deliver and evaluate an evidence-based interdisciplinary model of care to women living in a regional Victorian area. This small-scale study will assist the regional health service develop a sustainable and effective model of care that fits their local resources and context. The hypothesis is that an interdisciplinary model of care for pelvic pain will be feasible in a regional health service (NHW), when supported by specialised services from the RWH, a “hub and spoke model of care”.

Interventions

A multi/interdisciplinary model of care for chronic pelvic pain. Multi/interdisciplinary care for chronic pelvic pain is best practice, as recommended by a recent systematic review from our team and international clinical practice guidelines. In this study, we will test the feasibility of an interdisciplinary model of care, based on the model of care in current practice at Royal Women's Hospital (RWH), in a regional setting, Northeast Health Wangaratta (NHW). The intervention will be provided

A multi/interdisciplinary model of care for chronic pelvic pain. Multi/interdisciplinary care for chronic pelvic pain is best practice, as recommended by a recent systematic review from our team and international clinical practice guidelines. In this study, we will test the feasibility of an interdisciplinary model of care, based on the model of care in current practice at Royal Women's Hospital (RWH), in a regional setting, Northeast Health Wangaratta (NHW). The intervention will be provided by a team of clinicians representing different disciplines who work in pelvic pain clinics at RWH and NHW. This study will be conducted in three phases: Phase 1 will co-design the model of care; Phase 2 will deliver the model of care; Phase 3 will evaluate the feasibility of the model of care. Phase 1: -A co-design process; will involve team/stakeholder meetings, identification of needs of local service, resource sharing, mentoring of clinical skills and confidence gaps. We will have representation from 1 – 2 community-dwelling women with lived experience of pelvic pain (+/- diagnosis of endometriosis) in the co-design process. -We expect 4 – 6 NHW staff participants will participate. Clinicians who provide (or intend to provide) care in an interdisciplinary model of care (general practitioners, gynaecologists, nurses, physiotherapists, psychologists, dietitian) and administrative staff associated with the service will be invited. -The co-design process will be informed by an Australian experience-based co-design framework and the UK Medical Research Council framework for developing and evaluating complex interventions. - The frequency and duration of involvement: anticipated to be three 1 hour workshops delivered over a period of 3 weeks, email communications, development of a web-based portal with resources, - Phase 1 will occur prior to the intervention phase. It is anticipated to occur over a 4 week period. e.g. if Phase 1 starts in April 2026, Phase 2 would commence in May 2026. Phase 2: -Delivery of model of care to eligible NHW patients, expected to be 3 – 6 in the time frame of the study. These NHW patient participants with CPP will be referred to and eligible to enter the RWH clinical program. The exact clinical program delivered will be determined by the results of Phase 1, the co-design process. We expect a hybrid model of care will be developed, with a mix of face-to-face and telehealth consultations, with the option of on-site at NHW, and a hybrid of clinician care, with a mix of RWH-only, NHW-only and RWH-NHW co-consultation being delivered. We will start with a proposal of a model of care similar to the existing program delivered at RWH, but expect the co-design process may introduce some changes. The elements of model of care may be similar to the following TIDieR checklist: Brief Name: Interdisciplinary model of care for women with pelvic pain in a regional setting Why: Multi/interdisciplinary care for chronic pelvic pain is best practice, as recommended by a recent systematic review and international clinical practice guidelines . All patients, whether metropolitan or regional, deserve access to recommended best practice. What - Materials: RWH patient educational website (URL not available for public access) and education of regional clinicians informed by the co-design phase but likely to include resources and 1:1 mentoring. What - Procedures: 1. Introductory Nurse Phone Call (includes education about the program and access to online Early Intervention Pelvic Pain clinic portal resources [videos and written information]). 2. Clinical Care (Up to 2 pain specialist appointments, 4 physiotherapy appointments, 4 psychology appointments, 4 dietetics appointments and 3 phone calls with a nurse). - Pain specialist management may include medical assessment/investigation, referral to relevant medical specialties and allied health, education and pharmacological management. - Nursing management may include education and care-coordination. - Physiotherapy management may include pain science education, pelvic floor muscle exercises, bladder/bowel advice, relaxation strategies, breathing exercises, use of electrotherapy, lifestyle modification to avoid aggravating activities and pain flare-up self-management plan. - Psychology may include cognitive behavioural pain management, instruction in mindfulness, strategies to address psychological, social and relationship distress. - Dietetics may include education and dietary modifications, specific diet plans to treat gut symptoms. Who: A team of clinicians representing different disciplines who work in pelvic pain clinics at Royal Women's Hospital (RWH) and Northeast Health Wangaratta (NHW). This includes clinical disciplines of pain medicine specialist, pain nurse, physiotherapist, psychologist and dietitian. How: Face-to-face or via telehealth, 1-2 clinicians : 1 patient Where: Either in-person at Northeast Health Wangaratta (private consultation room), or via telehealth (HealthDirect platform). When and How Much: The program is delivered over a 4-6-month period of time. Introductory nurse phone call takes 20-30 minutes. Each appointment is up to 45 minutes long. Appointments are flexible but are typically scheduled fortnightly or monthly, depending on individual treatment plan. Nurse follow-up phone calls will occur periodically to check on patient progress. Tailoring: Individualised based on discipline specific assessment of patient needs. Modifications: NA How Well - Planned: Fidelity of delivery - EMR audit Fidelity of receipt and enactment - Semi-structured interviews. How Well - Actual: NA Phase 3: -Evaluation of model of care: All participants from phase 2 will be invited to complete the pre- and post-program evaluation surveys. The evaluation will focus on the outcomes of feasibility, acceptability, satisfaction, fidelity, health service usage and clinical outcomes. - All participants (patients and staff) will be invited to participate in a post-program interview to explore their experiences of the program. This will be conducted in a separate qualitative study from the program evaluation quantitative survey. - Interview details: Semi-structured interviews (approximately 1 hour in duration) will be conducted by a member of the research team experienced in the conduct of semi-structured interviews exploring patient and staff experiences of health services. Microsoft TEAMS platform will be used for patient and staff interviews. Interpreters will be used during the interview for NESB patient participants. Interviews will be audio-recorded and transcribed verbatim.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

-The health service: a regional public health service (NHW) that does not currently provide an interdisciplinary service with clinicians specialised in pelvic pain -The patient participants: NHW patients who present to the gynaecology clinic for treatment of chronic pelvic pain or endometriosis -The staff participants: NHW staff involved in the design, delivery and evaluation of the model of care

Exclusion criteria

Patients: -Patient-participants who have previously received an interdisciplinary model of care including pain physician, clinical nurse consultant, physiotherapy, psychology or dietetic services Staff: -No exclusions apply.

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 4, 2026