Prime Institute of Health Sciences, Islamabad
Islamabad, Punjab Province, 44000, Pakistan
NCT Number: NCT07754305
The research investigating the effects of Diaphragm-Pelvic Floor Synergy (DPFS) training targets primary dysmenorrhea in university-aged females. This randomized controlled trial evaluates how restoring the functional "piston" relationship between the diaphragm and pelvic floor can alleviate menstrual pain and enhance quality of life. By implementing an eight-week progressive exercise protocol, the study compares DPFS training against standard symptomatic care like TENS and heat therapy. Using the WALIDD scale and WHOQOL-BREF, the research aims to establish a non-pharmacological, evidence-based physiotherapy intervention that reduces medication reliance and academic absenteeism in South Asian clinical settings.
Trial opening soon.
Get Notified18 year–24 year
Female
Interventional
Not applicable
Islamabad, Punjab Province, 44000, Pakistan
The research investigates the functional relationship between the thoracic diaphragm and pelvic floor muscles, often described as a "piston" mechanism, and its role in managing primary dysmenorrhea. In healthy individuals, these muscle groups contract and relax in coordination to regulate intra-abdominal pressure and provide core stability. However, young females with primary dysmenorrhea frequently experience disrupted synergy due to shallow breathing and increased pelvic tension, which exacerbates the intensity of menstrual cramps and negatively impacts their physical and psychological well-being. To address this, a randomized controlled trial will be conducted at the Prime Institute of Health Sciences, involving 64 participants aged 18 to 25. The study compares a structured eight-week Diaphragm-Pelvic Floor Synergy (DPFS) training program against standard symptomatic care, such as TENS and heat therapy. The intervention group will perform specific exercises three times per week, progressing from supine to standing positions to challenge the core muscles under varying gravitational loads. This progression aims to recalibrate the respiratory-pelvic coordination and improve neuromuscular control.
Outcomes are measured using the WALIDD scale for pain severity and the WHOQOL-BREF for quality of life assessments. By focusing on the physiological root of core instability rather than just temporary symptom suppression, the study aims to establish an evidence-based physiotherapy protocol. This approach offers a sustainable, non-pharmacological alternative for managing menstrual pain, ultimately seeking to reduce academic absenteeism and long-term reliance on analgesics among young women in South Asian clinical settings.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention is a supervised 8-week program consisting of 3 sessions per week. It focuses on the functional coordination of the thoracic diaphragm and pelvic floor muscles to regulate intra-abdominal pressure. The protocol involves a "piston" technique where participants perform a 4-second slow inhalation (allowing the pelvic floor to relax and descend) followed by a 6-second pursed-lip exhalation (actively contracting and elevating the pelvic floor). The training is progressive, advancing every two weeks through four postural levels: supine, sitting, quadruped, and standing.
This arm receives established clinical treatments for menstrual pain. During the first three days of the menstrual cycle, participants receive 30 minutes of High-Frequency Transcutaneous Electrical Nerve Stimulation (TENS) at 100 Hz and 20 minutes of moist heat therapy. On non-menstrual days, they participate in supervised Progressive Muscle Relaxation (PMR) sessions three times per week to manage general muscle tension and stress.
Time frame: Baseline (Pre-intervention), 8 weeks (Immediate post-intervention), and 3 months (Follow-up).
The WALIDD scale is a validated multi-dimensional tool used to assess the severity of primary dysmenorrhea. It evaluates five specific areas: work interference, anatomical location of pain, pain intensity, duration of symptoms, and the clinical grade of dysmenorrhea. Scores range from 0 to 12, where 1-4 indicates mild, 5-7 moderate, and 8-12 severe pain.
Time frame: Baseline (Pre-intervention), 8 weeks (Immediate post-intervention), and 3 months (Follow-up).
This is a 26-item questionnaire used to assess quality of life across four major domains: physical health, psychological health, social relationships, and environment. It measures how the intervention impacts the participants' overall well-being and daily functioning. Each item is rated on a 5-point Likert scale.
Contact information is provided by the study sponsor or research team.
Rida Zafar, WHPT
CONTACT
Summra Andleeb, MSOMPT
CONTACT
Riphah International University
Other
Effects of Diaphragm-Pelvic Floor Synergy Training on Pain and Quality of Life in Young Females With Primary Dysmenorrhea.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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