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Trial registered on ANZCTR


Registration number
ACTRN12622001393741
Ethics application status
Approved
Date submitted
7/10/2022
Date registered
31/10/2022
Date last updated
23/02/2024
Date data sharing statement initially provided
31/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pelvic floor muscle exercises and mindfulness for women with endometriosis-associated pelvic pain
Scientific title
Pelvic floor muscle exercises and mindfulness for women with endometriosis-associated pelvic pain: a pilot and feasibility study
Secondary ID [1] 308055 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis-associated pelvic pain 327747 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324818 324818 0 0
Physiotherapy
Reproductive Health and Childbirth 325056 325056 0 0
Other reproductive health and childbirth disorders
Musculoskeletal 325057 325057 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aim of this study is to evaluate the feasibility and acceptability of conducting a randomised controlled study that includes pelvic floor muscle (PFM) exercise and mindfulness delivered in a hybrid mode (face-to-face sessions and remote sessions) for women with endometriosis-associated pelvic pain.
The sessions will be conducted one-on-one. The research team will randomise participants to one of two PFM exercise protocols:
Arm1: PFM contraction plus relaxation exercise + mindfulness.
Arm 2: PFM relaxation exercise + mindfulness.

Arm1: women will receive eight weeks of PFM contraction plus relaxation exercises and mindfulness. Women will be asked to attend four face-to-face sessions at Monash University over a period of 8 weeks of supervised PFM exercise and four Zoom video- consultations to practise PFM exercises and mindfulness under the physiotherapist’s supervision and guidance. PFM exercises and mindfulness will be taught by the physiotherapy researcher (PhD student with training in PFM contraction and relaxation exercises and mindfulness) using a standardised protocol. Women will be asked to perform fast PFM contraction, PFM maximal contraction, and PFM endurance exercises. Each PFM contraction exercise will be followed by a PFM relaxation exercise. Therefore, the anticipated ratio of contraction to relaxation exercises is one contraction exercise to one relaxation exercise. The PFM exercise protocol will be progressed gradually through the addition of repetitions and alterations in exercise positions (supine, sitting, and standing). The progression will be based on a set time-based program (everybody does the same thing at the same time-point). However, individual rate of progression and response (i.e. individual ability to contract and hold PFM and the number of repetitions) will determine exact progression for each individual.
Mindfulness exercises will include breath awareness and body scan practice.

During the face-to-face treatment sessions, women will use a single-patient intravaginal probe connected to a surface electromyography (sEMG) biofeedback unit. The sEMG biofeedback unit will be used in clinic to educate participants in performing the correct PFM exercises (at weeks 1, 2, 5, and 8). At home, women will be asked to keep a diary to record PFM contraction plus relaxation exercises and the frequency of practice of mindfulness sessions throughout the eight weeks.

The estimated time for each supervised treatment session is 45 mins. The frequency of the sessions is 1x 45 mins session per week for 8 weeks.

All participants will be asked to perform the PFM contraction plus relaxation exercise + mindfulness protocol at home for the same frequency and duration as the in-clinic protocol. Participants will be asked to keep a diary to record PFM contraction plus relaxation exercises + mindfulness practice frequency throughout the eight weeks. The diary will be reviewed weekly by the physiotherapist. The exercise diary and session attendance checklists will be used as strategies to assess or monitor adherence to the intervention.
Intervention code [1] 324503 0
Rehabilitation
Intervention code [2] 324700 0
Treatment: Other
Comparator / control treatment
Arm 2 (Active control): PFM relaxation exercise + mindfulness.
Women will receive eight weeks of PFM relaxation exercise and mindfulness. Women will be asked to attend four face-to-face sessions at Monash University over a period of 8 weeks of supervised PFM relaxation exercise and mindfulness and four Zoom video-consultations to practice PFM relaxation exercise and mindfulness under the physiotherapist’s supervision and guidance. The sessions will be conducted one-on-one. PFM relaxation exercise and mindfulness will be taught by the physiotherapy researcher (PhD student with training in PFM relaxation exercises and mindfulness) using a standardised protocol.

The PFM exercise protocol will focus on breathing and relaxing PFM muscles (without PFM contraction). The PFM exercise protocol will be progressed gradually through the addition of repetitions and alterations in exercise positions (supine, sitting, and standing). The progression will be based on a set time-based program (everybody does the same thing at the same time-point). However, individual rate of progression and response (i.e., individual ability to relax PFM and the number of repetitions) will determine exact progression for each individual. Mindfulness exercises will be the same as those taught to the intervention group.

During the face-to-face treatment sessions, women will use a single-patient intravaginal probe connected to a surface electromyography (sEMG) biofeedback unit. The sEMG biofeedback unit will be used in clinic to educate participants in performing the correct PFM exercise (at weeks 1, 2, 5, and 8). At home, women will be asked to keep a diary to record PFM relaxation exercise and the frequency of practice mindfulness sessions throughout the eight weeks.

The estimated time for each supervised treatment session is 45 mins. The frequency of the sessions is 1x 45 mins session per week for 8 weeks.

All participants will be asked to perform the PFM relaxation exercise + mindfulness protocol at home for the same frequency and duration as the in-clinic protocol. Participants will be asked to keep a diary to record PFM relaxation exercises + mindfulness practice frequency throughout the eight weeks. The diary will be reviewed weekly by the physiotherapist. The exercise diary and session attendance checklists will be used as strategies to assess or monitor adherence to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 332639 0
Feasibility outcome: a retention rate will be calculated as the proportion of participants who complete all 8 weeks of intervention. This will be assessed by an attendance checklist.
Timepoint [1] 332639 0
Last intervention session (week 8).
Primary outcome [2] 332659 0
Feasibility outcome: a recruitment rate will be calculated as the number of participants who are eligible and provide consent for randomisation out of those who express interest in the trial. This will be assessed by study screening and enrolment logs.
Timepoint [2] 332659 0
At the conclusion of the trial.
Primary outcome [3] 332660 0
Feasibility outcome: adherence rate to the home program will be monitored through exercise diaries completed by the participants.
Timepoint [3] 332660 0
Last intervention session (week 8).
Secondary outcome [1] 414172 0
Feasibility outcome: details of any adverse events that occur will be documented by the physiotherapy researcher as they arise. Examples of possible adverse events that could occur are pain or discomfort during or after performing PFM exercises. Any adverse events reported by participants during or after the intervention session will be recorded by the research team.
Timepoint [1] 414172 0
Throughout the duration of the 8-week intervention period until the final assessment timepoint (within 1 week of the final intervention session).
Secondary outcome [2] 414292 0
Intervention acceptability will be assessed by five study-specific questions. The questions will be rated on a 5-point Likert scale.
Timepoint [2] 414292 0
This outcome will be collected post-intervention as part of the final assessment questionnaire (within 1 week of final intervention).
Secondary outcome [3] 414293 0
Intervention satisfaction will be assessed using seven-point patient global impression of change.
Timepoint [3] 414293 0
This outcome will be collected post-intervention as part of the final assessment questionnaire (within 1 week of final intervention).
Secondary outcome [4] 414294 0
The most bothersome pelvic pain symptom. Participants will be asked to select the most bothersome pain symptom: pelvic pain in general (any pain that occurs in the lowest part of the abdomen), pelvic pain during period, pelvic pain during intercourse, pelvic pain with bowel movement, or pelvic pain with urination.
Timepoint [4] 414294 0
T1: Pre-intervention, baseline assessment.
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention).
Secondary outcome [5] 415272 0
The presence and intensity of pelvic pain in general (any pain that occurs in the lowest part of the abdomen). Participants will be asked to rate their pelvic pain intensity on an 11-point numerical rating scale (NRS) ranging from 0 “no pain” to 10 “worst pain imaginable”
Timepoint [5] 415272 0
T1: Pre-intervention, baseline assessment
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention)
Secondary outcome [6] 415273 0
The presence and intensity of pelvic pain during period (dysmenorrhea). Participants will be asked to rate their pelvic pain intensity on an 11-point numerical rating scale (NRS) ranging from 0 “no pain” to 10 “worst pain imaginable”
Timepoint [6] 415273 0
T1: Pre-intervention, baseline assessment
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention)
Secondary outcome [7] 415274 0
The presence and intensity of pelvic pain during intercourse (dyspareunia). Participants will be asked to rate their pelvic pain intensity on an 11-point numerical rating scale (NRS) ranging from 0 “no pain” to 10 “worst pain imaginable”
Timepoint [7] 415274 0
T1: Pre-intervention, baseline assessment
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention)
Secondary outcome [8] 415275 0
The presence and intensity of pelvic pain with bowel movement (dyschezia). Participants will be asked to rate their pelvic pain intensity on an 11-point numerical rating scale (NRS) ranging from 0 “no pain” to 10 “worst pain imaginable”
Timepoint [8] 415275 0
T1: Pre-intervention, baseline assessment
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention)
Secondary outcome [9] 415276 0
The presence and intensity of pelvic pain with urination (dysuria). Participants will be asked to rate their pelvic pain intensity on an 11-point numerical rating scale (NRS) ranging from 0 “no pain” to 10 “worst pain imaginable”
Timepoint [9] 415276 0
T1: Pre-intervention, baseline assessment
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention)
Secondary outcome [10] 415277 0
Pelvic pain frequency using a question “Approximately how often did you have this pain for in the last 3 months?”. Participants will be asked to complete the question using a Likert scale with the end points “Less than one day a month” and “Every day”.
Timepoint [10] 415277 0
T1: Pre-intervention, baseline assessment
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention)
Secondary outcome [11] 415278 0
Pelvic pain-related interference using a question “To what extent has your pain interfered with your normal social activities in the last 3 months?”: participants will be asked to rate the pain-related interference using a Likert scale ranging from 0 “not at all” to “not applicable”
Timepoint [11] 415278 0
T1: Pre-intervention, baseline assessment
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention)
Secondary outcome [12] 415279 0
Pelvic pain affect (experience) using a question “When you had pelvic pain in the last 3 months, what did it feel like?” Participants will be asked to complete the question using a Likert scale with the end points “none” to “Severe”.
Timepoint [12] 415279 0
T1: Pre-intervention, baseline assessment
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention)
Secondary outcome [13] 415280 0
Pain catastrophizing will be measured with the Pain Catastrophizing Scale (PCS). Participants will be asked to complete a PCS based on their pelvic pain using a Likert scale with the end points “not at all” and “all the time.”
Timepoint [13] 415280 0
T1: Pre-intervention, baseline assessment
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention)
Secondary outcome [14] 415281 0
Pain-related fear using the short version of the Pain Anxiety Symptoms Scale (PASS). Participants will be asked to rate 20 assertions based on the feelings when pelvic pain is present using a Likert scale ranging from 0“never” to 5 “always.”
Timepoint [14] 415281 0
T1: Pre-intervention, baseline assessment
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention)
Secondary outcome [15] 415282 0
Pain self-efficacy questionnaire (PSEQ). Participants will be asked to complete the PSEQ using a Likert scale ranging from 0“not at all confident” to 6“Completely confident”.
Timepoint [15] 415282 0
T1: Pre-intervention, baseline assessment
T2: Post-intervention as part of the final assessment questionnaire (within 1 week of final intervention)
Secondary outcome [16] 415283 0
Pelvic floor muscle morphometry outcome: Anorectal angle at rest and during PFM contraction measured by three- and four-dimensional transperineal ultrasound imaging (3/4D TPUSI).
Timepoint [16] 415283 0
T1: Pre-intervention, baseline assessment
T2: Immediately following the last intervention session (week 8)
Secondary outcome [17] 415285 0
Pelvic floor muscle morphometry outcome: Hiatal area at rest and during PFM contraction measured by 3/4D TPUSI.
Timepoint [17] 415285 0
T1: Pre-intervention, baseline assessment
T2: Immediately following the last intervention session (week 8)
Secondary outcome [18] 415286 0
Pelvic floor muscle morphometry outcome: Anterior-posterior diameter of the levator hiatus at rest and during PFM contraction measured by 3/4D TPUSI.
Timepoint [18] 415286 0
T1: Pre-intervention, baseline assessment
T2: Immediately following the last intervention session (week 8)
Secondary outcome [19] 415287 0
Participants' experiences and intervention acceptability will be assessed by one-on-one semi-structured interviews with participants via video conference (Zoom). The interview will be conducted by a member of the research team. The interview questions will be modified from the Theoretical Framework of Acceptability.
Timepoint [19] 415287 0
Post-intervention (within 3 months of the final intervention)

Eligibility
Key inclusion criteria
1) Women are between 18-45 years of age; 2) have or have had in the past, a diagnosis of endometriosis confirmed by laparoscopy or imaging; 3) nulliparous or have not been pregnant beyond 12 weeks; 4) are pre-menopausal; 5) have a mean score of at least 4 out of 10 on the numeric rating scale (NRS) for pelvic pain intensity (any of the following symptoms: pelvic pain in general, dysmenorrhea, dyspareunia, dyschezia, or dysuria), cyclic or non-cyclic; 6) have had pelvic pain for a minimum of three months; 7) have a good home internet connection and device with capability of operating zoom software, and a webcam; and 8) have sufficient English language skills to participate.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously received physiotherapy treatment for endometriosis (more than two sessions within the previous two years), a history of major gynaecological surgery (except if the surgery was for endometriosis), neurological disorders, active vaginal infection, and intellectual/mental impairments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A researcher from the supervisory team who will not be involved in either participant recruitment or administration of outcome measures will manage this concealed randomisation list and assign participants into groups. The randomisation schedule will be stored on a password-protected website at Monash University and group allocation will be revealed by this same researcher after baseline assessment has been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur before the start of the interventions in a 1:1 ratio. Randomisation will be stratified by centre using random permuted blocks (size, 4-6) from a computer-generated list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
A pilot and feasibility study
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative data analysis:
Descriptive statistics including frequencies and percentages, means and standard deviations, or median and inter-quartile range (IQR) will be used to summarise participants’ sociodemographic characteristics and clinical information. Feasibility outcomes will be evaluated using descriptive statistics. Data will be assessed for normality using the Shapiro-Wilk test. Differences in clinical outcomes will be assessed using linear mixed effects models that include fixed-effect terms for baseline measures and treatment group and a random subject term. Explanatory variables that will be included as covariates in the model include age, BMI, pelvic pain intensity, the presence of pelvic pain symptoms, and endometriosis stages). All analyses will be tested with a significance level of p<0.05 using SPSS 20.0 software (IBM Corp, Armonk, NY).

Qualitative analysis:
Data will be analysed using descriptive thematic analysis. Interview transcripts will be read by the researcher to familiarise herself with the data and sorting the data. Transcripts then will be coded to identify similar themes with text indexed into topics, each identified with a short descriptor. To demonstrate the credibility and confirmability of the emergent themes and patterns, coding will also be performed by a second researcher. Results will be compared, and differences will be discussed until a consensus is reached. Themes and sub-themes will be presented with exemplary quotes from interviews to demonstrate the transferability of the results.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/01/2023
Actual
6/03/2023
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
56
Accrual to date
45
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23229 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 38597 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 312310 0
University
Name [1] 312310 0
Monash University
Country [1] 312310 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Moorooduc Hwy, Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 313865 0
None
Name [1] 313865 0
Nil
Address [1] 313865 0
Nil
Country [1] 313865 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311679 0
Human Research Ethics Committee-Monash Health
Ethics committee address [1] 311679 0
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 311679 0
Australia
Date submitted for ethics approval [1] 311679 0
23/08/2022
Approval date [1] 311679 0
17/02/2023
Ethics approval number [1] 311679 0

Summary
Brief summary
The primary aim of this study is to evaluate the feasibility and acceptability of conducting a randomised controlled study that includes pelvic floor muscle (PFM) exercise and mindfulness delivered in a hybrid mode (four face-to-face sessions and four remote sessions) for women with endometriosis associated pelvic pain. In addition, we will measure the changes in PFM dimensions before and after the eight weeks of the treatment protocol. We aim to recruit 56 participants with a confirmed diagnosis of endometriosis from health services or via social media. Participants will be asked to complete online questionnaires and undergo ultrasound assessments before and after eight weeks of PFM exercises and mindfulness. All participants will also be invited to participate in an interview after the completion of the eight weeks of the treatment protocol to talk about their experience and the acceptability of the pelvic floor exercises and mindfulness interventions. We will recruit a purposive sample of women for this interview.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121970 0
Dr Sze-Ee Soh
Address 121970 0
Department of Physiotherapy
School of Primary and Allied Health Care
Monash University
Moorooduc Hwy, Frankston VIC 3199
Country 121970 0
Australia
Phone 121970 0
+61 3 990 44122
Fax 121970 0
Email 121970 0
[email protected]
Contact person for public queries
Name 121971 0
Shaza Kadah
Address 121971 0
Department of Physiotherapy
School of Primary and Allied Health Care
Monash University
Moorooduc Hwy, Frankston VIC 3199
Country 121971 0
Australia
Phone 121971 0
+61 0410137702
Fax 121971 0
Email 121971 0
[email protected]
Contact person for scientific queries
Name 121972 0
Shaza Kadah
Address 121972 0
Department of Physiotherapy
School of Primary and Allied Health Care
Monash University
Moorooduc Hwy, Frankston VIC 3199
Country 121972 0
Australia
Phone 121972 0
+61 0410137702
Fax 121972 0
Email 121972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.