Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001101370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
5/08/2026
Date registered
Help: Date registered
7/09/2026
Date last updated
Help: Date last updated
9/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
7/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Shared Medical Appointments for Women Living with Endometriosis: a Feasibility Study
Scientific title
Shared Medical Appointments for Women Living with Endometriosis: a Feasibility Study
Additional trial identifiers [1] 318078 0
Nil
Universal Trial Number (UTN)
Trial acronym
SMA-Endo
Related trial records

Health condition
Health condition(s) studied:
Endometriosis 343104 0
Condition category
Condition code
Reproductive Health and Childbirth 339197 339197 0 0
Other reproductive health and childbirth disorders
Alternative and Complementary Medicine 339198 339198 0 0
Other alternative and complementary medicine
Physical Medicine / Rehabilitation 339199 339199 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is a programmed Shared Medical Appointment program (SMA) at the WSIH Myhealth Integrative Medical Centre at Westmead. The SMAs will include 8-10 participants. It involves six pSMAs (90-120 minutes), delivered face to face to a group of patients by a clinician (general practitioner (GP)) and a facilitator (a degree-qualifed naturopathic practitioner). The individual GP consultations will occur within the group program format. Both practitioners will be trained in SMA facilitation through the Australasian Society of Lifestyle Medicine.
The SMA program is based on that piloted by Gardiner et al. (1) and Gerontakis et al. (2) for individuals currently living with endometriosis and consists of six 90 minute programmed Shared Medical Appointments. The content of the program will be reviewed and modified by a steering committee prior to the start of the program. Educational content will include: overall understanding of endometriosis , pain management and importance of lifestyle modifications; healthy eating for endometriosis; sleep quality; and supporting psychological wellbeing. Short home practice activities, for example a 15 min daily yoga routine to reduce chronic pain will be planned for each session. Educational materials will be provided where application eg a video of yoga practice. Adherence to daily activities will be monitored via a checklist at the start of each session.
The schedule for the SMA is as follows:

Introduction and warm-up (facilitator only) 5 minutes
Individual GP consultations 50-60 minutes
Structured educational session (facilitator and allied health professional) 30 minutes
Home practice review and reflection 5 minutes

1. Gardiner, P., M. Luo, S. D'Amico, K. Gergen-Barnett, L. F. White, R. Saper, S. Mitchell and J. M. Liebschutz (2019). "Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial." PLoS One 14(12): e0225540.
2. Gerontakos, S., Steel, A., & Wardle, J. (2025). Naturopathic Medicine for Endometriosis (NatME). Results of a pilot study. https://doi.org/10.21203/rs.3.rs-7396031/v1

Intervention code [1] 334960 0
Prevention
Intervention code [2] 334965 0
Lifestyle
Intervention code [3] 335122 0
Treatment: Other
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346438 0
Recruitment rate
Timepoint [1] 346438 0
Baseline - after recruitment is complete
Primary outcome [2] 346439 0
Adherence rate
Timepoint [2] 346439 0
13 weeks post-first SMA
Primary outcome [3] 346610 0
Retention rate
Timepoint [3] 346610 0
13 weeks post first SMA
Secondary outcome [1] 465844 0
Pelvic pain severity
Timepoint [1] 465844 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [2] 465845 0
Pelvic pain frequency
Timepoint [2] 465845 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [3] 465846 0
Most impactful symptom
Timepoint [3] 465846 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [4] 465847 0
Fatigue
Timepoint [4] 465847 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [5] 465848 0
Analgesic usage
Timepoint [5] 465848 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [6] 465849 0
Absenteeism/presenteeism
Timepoint [6] 465849 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [7] 466710 0
Dysuria severity
Timepoint [7] 466710 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [8] 466711 0
Severity of dyschezia
Timepoint [8] 466711 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [9] 466712 0
Health-related quality of life
Timepoint [9] 466712 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [10] 466713 0
Health-related quality of life
Timepoint [10] 466713 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [11] 466985 0
Severity of dyspareunia
Timepoint [11] 466985 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [12] 466986 0
Frequency of dyspareunia
Timepoint [12] 466986 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [13] 466987 0
Acceptability of intervention
Timepoint [13] 466987 0
13 weeks post first SMA
Secondary outcome [14] 466988 0
Safety
Timepoint [14] 466988 0
13 weeks post first SMA
Secondary outcome [15] 467315 0
Frequency of dysuria
Timepoint [15] 467315 0
Baseline compared to 13 weeks post first SMA
Secondary outcome [16] 467316 0
Frequency of dyschezia
Timepoint [16] 467316 0
Baseline compared to 13 weeks post first SMA

Eligibility
Key inclusion criteria
Aged 18 years or above
A confirmed diagnosis of endometriosis, either via surgery (laparoscopy) or imaging (ultrasound/MRI)
Living in Western Sydney
Able to read and understand English and provide written informed.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Any medical, psychological, or social condition that, in the opinion of the investigators, would make participation unsafe or place undue burden on the participant.
Trying to conceive or currently pregnant.
Unable to attend SMAs at Western Sydney Integrative Health (WSIH) Myhealth Medical Centre

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
SMAs typically involve 8-10 patients per group. We will include 10 participants allowing for two dropouts. The sample size is appropriate for feasibility testing and signal detection.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
8/09/2026
Actual
8/09/2026
Date of last participant enrolment
Anticipated
8/09/2026
Actual
8/09/2026
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
10
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322638 0
Charities/Societies/Foundations
Name [1] 322638 0
Jacka Foundation of Natural Therapies
Country [1] 322638 0
Australia
Primary sponsor type
University
Name
NICM Health Research Institute, University of Western Sydney
Address
Country
Australia
Secondary sponsor category [1] 325566 0
None
Name [1] 325566 0
Address [1] 325566 0
Country [1] 325566 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321096 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 321096 0
Ethics committee country [1] 321096 0
Australia
Date submitted for ethics approval [1] 321096 0
Approval date [1] 321096 0
22/07/2026
Ethics approval number [1] 321096 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152650 0
Dr Alison Maunder
Address 152650 0
NICM Health Research Institute, 158 Hawkesbury Rd, Westmead NSW 2145
Country 152650 0
Australia
Phone 152650 0
+61 2 9685 4749
Fax 152650 0
Email 152650 0
[email protected]
Contact person for public queries
Name 152651 0
Alison Maunder
Address 152651 0
NICM Health Research Institute, 158 Hawkesbury Rd, Westmead NSW 2145
Country 152651 0
Australia
Phone 152651 0
+61 2 9685 4749
Fax 152651 0
Email 152651 0
[email protected]
Contact person for scientific queries
Name 152652 0
Alison Maunder
Address 152652 0
NICM Health Research Institute, 158 Hawkesbury Rd, Westmead NSW 2145
Country 152652 0
Australia
Phone 152652 0
+61 2 9685 4749
Fax 152652 0
Email 152652 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.