Pelvic floor muscle exercises and mindfulness for women with endometriosis-associated pelvic pain

INTERVENTION: 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 CONDITION: Endometriosis‐associated pelvic pain ; ; Endometriosis‐associated pelvic pain Musculoskeletal ‐ Other muscular and skeletal disorders Physical Medicine / Rehabilitation ‐ Physiotherapy Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders PRIMARY OUTCOME: 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.[ At the conclusion of the trial.] 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. [Last intervention session (week 8).] Feasibility outcome: adherence rate to the home program will be monitored through exercise diaries completed by the participants.[Last intervention session (week 8).] SECONDARY OUTCOME: 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. [Throughout the duration of the 8‐week intervention period until the final assessment timepoint (within 1 week of the final intervention session). ] Intervention acceptability will be assessed by five study‐specific questions. The questions will be rated on a 5‐point Likert scale.[This outcome will be collected post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention).] Intervention satisfaction will be assessed using seven‐point patient global impression of change.[This outcome will be collected post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention).] 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.”[T1: Pre‐intervention, baseline assessment ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention) ; ] 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”.[T1: Pre‐intervention, baseline assessment ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention) ; ] 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.”[T1: Pre‐intervention, baseline assessment ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention) ; ] 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.[Post‐intervention (within 3 months of the final intervention) ] 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).[T1: Pre‐intervention, baseline assessment ; T2: Immediately following the last intervention session (week 8) ; ] Pelvic floor muscle morphometry outcome: Anterior‐posterior diameter of the levator hiatus at rest and during PFM contraction measured by 3/4D TPUSI.[T1: Pre‐intervention, baseline assessment ; T2: Immediately following the last intervention session (week 8) ; ] Pelvic floor muscle morphometry outcome: Hiatal area at rest and during PFM contraction measured by 3/4D TPUSI.[T1: Pre‐intervention, baseline assessment ; T2: Immediately following the last intervention session (week 8) ; ] 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”.[T1: Pre‐intervention, baseline assessment ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention) ; ] 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”.[T1: Pre‐intervention, baseline assessment ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention) ; ] 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”[T1: Pre‐intervention, baseline assessment ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention) ; ] 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.[T1: Pre‐intervention, baseline assessment. ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention). ; ] 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” [T1: Pre‐intervention, baseline assessment ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention) ; ] 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” [T1: Pre‐intervention, baseline assessment ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention) ; ] 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” [T1: Pre‐intervention, baseline assessment ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention) ; ] 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” [T1: Pre‐intervention, baseline assessment ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention) ; ] 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” [T1: Pre‐intervention, baseline assessment ; T2: Post‐intervention as part of the final assessment questionnaire (within 1 week of final intervention) ; ] 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.