Effects of a Combined Home-Based Exercise Program on Menstrual Pain, Dual-Task Gait Performance, and Neurophysiological Outcomes in Primary Dysmenorrhoea: A Randomised Controlled Trial Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Sharjah
- Enrollment
- 86
Study Overview
Brief Summary
What is this study about? Dysmenorrhea, commonly known as painful period, is a common gynecological symptom experienced by several women of reproductive age. This particular type of pain arises during the menstrual cycle, often negatively impacting the quality of life and ability to successfully carry out daily activities and academic or work performance. This is study will involve physiotherapy treatment in the form of a home-based exercise program for those experiencing dysmenorrhea. The purpose of this study is to determine how effective this exercise intervention is by assessing the pain score, menstrual symptoms, gait performance and cognitive-motor control.
Detailed Description
What will the participant have to do if they take part? They will be asked to come to the University of Sharjah so the investigators can get some measurements. The participant will be asked to fill a form with the basic information about themselves, including as name, age, occupation, height, weight and contact details. They will also be asked about their menstrual pain score on VAS pain scale and to complete a questionnaire about their menstrual symptoms and lifestyle (such as physical activity, sleep, diet etc.). The physiotherapist will then give them a demonstration of the exercises they need to do during this 8-week program. The participant will be required to follow a video recording of the exercises to complete 3 sessions each week, for about 30 minutes. Necessary follow-up will take place each week. They will be given an exercise diary to keep track of when they do these sessions and for how long. On completion of all sessions after 8 weeks, the assessment previously done will be repeated.
What is the criteria for being selected? They study includes females, aged between 18 and 25, who experience dysmenorrhea.
Possible risks of taking part? There are no risks from this study. All the information will be confidential and when the study is finished, they will be destroyed.
Are there any possible benefits? There is expected benefit of the exercises on decreasing menstrual pain and symptoms.
Does the participant have to take part in this study? No. Participation is completely voluntary. If the participant does not wish to consent, they can refuse. If they wish to take part and then change their mind later, they can withdraw from the study any time.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-25 years
- •meet the diagnostic criteria for PD as outlined in the Primary Dysmenorrhea Consensus Guidelines - first onset of menstrual pain 6-24 months after menarche, pain lasting 8-72h in a cycle, and the most severe pain on the 1st or 2nd day of menstruation
- •having a regular menstrual cycle (28 ± 7 days)
- •menstrual pain intensity ≥4 cm on VAS in the previous 6 months
- •absence of any known medical condition
Exclusion Criteria
- •history of pelvic surgery
- •history and/or findings of secondary dysmenorrhea
- •history of mental or physical diseases
- •history of joint, motion, muscle, or bone diseases which reduce the abilities to exercise
- •being a professional athlete
- •taking analgesic or non-pharmacological agents other than NSAID for menstrual pain
- •used an intrauterine device or oral contraceptive pill
- •metal implants, including pacemaker
- •history of non-normal brain activity, including seizures
Arms & Interventions
Intervention group
Intervention: Home-exercise program (Other)
Control group
Waitlist control group
Investigators
Zaina Ahmed
Graduate TA - PhD, Physiotherapy
University of Sharjah