None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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.