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NCT Number: NCT06615258

The Effect of Breathing-based Pelvic Floor Muscle Training on Menstrual Symptoms, Pain and Quality of Life

Primary dysmenorrheic (PD) pain usually begins during adolescence, at menarche or shortly after (6-24 months), and has a clear and predictable temporal pattern. The pain typically radiates to the back and thighs and lasts for 8-72 hours. The pain is most severe on the first and/or second day of menstrual bleeding. Additionally, systemic symptoms such as nausea, vomiting, diarrhea, fatigue, and insomnia often accompany the pain. In secondary dysmenorrhea, it can result from a range of identifiable pathological conditions, including endometriosis, adenomyosis, fibroids, and pelvic inflammatory disease. Other gynecological symptoms such as intermenstrual bleeding and menorrhagia may also accompany it, depending on the underlying condition. Empirical treatment approaches have been reported as appropriate for patients with primary dysmenorrhea based on symptoms and physical examination results. Recent studies have indicated that during diaphragmatic breathing, all the muscles that make up the thoracic and abdominal walls should expand in a cylindrical manner in all directions through synchronized eccentric activity. Thus, a more effective result will occur with the concentric contraction and 360-degree expansion of the diaphragm during inspiration, which raises intra-abdominal pressure .

Within the framework of this information, the aim of this study is to examine the effects of respiration-based physiotherapy approaches on menstrual symptoms, pain, and quality of life in women with PD.

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Key information

Conditions

Dysmenorrhea Primary Agnosia Diaphragmatic Breathing Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Pelvic Floor Muscle Exercise Perceptual Disorders Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Izmir University of Economics

Izmir, İzmir, 35330, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18-35,
  • Voluntary participation,
  • Having a regular menstrual cycle (every 24-35 days) ,
  • Menstrual pain intensity of 3/10 or higher on the Visual Analog Scale during the initial assessment,
  • Pain radiating to the back, legs, lower abdominal, or suprapubic region during menstruation,
  • Restriction of daily living activities due to pain,
  • Requirement for medical intervention or self-medication to control the pain.

Exclusion criteria

  • History of pelvic pathology and/or surgery that could cause pain,
  • Neurological or psychological disorders,
  • Anovulation,
  • Other diseases that could affect chest expansion or the respiratory system (COPD, asthma, pneumonia, bronchiectasis, etc.),
  • Being pregnant, having a positive birth control status, or being less than 6 months postpartum,
  • Use of an intrauterine device,
  • History of childbirth or miscarriage. Individuals who miss two consecutive exercise sessions will be excluded from the study.

Treatment and study plan

Dynamic Neuromuscular Stabilization based breathing training and pelvic floor muscle training

Behavioral

DNS-based breathing exercises will be taught to the women in this group using tactile biofeedback. To create tactile stimulation, one of the hard sponges placed within a belt will be positioned anteriorly in the inguinal region, and the other posteriorly in the Grynfeltt-Lesshaft triangle region. Breathing training will be provided in 3 different positions: sitting, crawling, and happy baby pose.

Pelvic floor muscle training: PFME will consist of 2 parts: relaxation training for pelvic floor muscles and pelvic floor muscle exercises.

Pelvic floor muscles will be given relaxation training in 3 different relaxation positions (modified butterfly pose, child pose and deep squatting position) suggested by Çeliker Tosun et al. PFME will be taught by the physiotherapist in the side-lying with external coccyx palpation. PFME will be applied in the hook-lying position, sitting position and standing position.

Pelvic floor muscle training

Behavioral

Pelvic floor muscle training: PFME will consist of 2 parts: relaxation training for pelvic floor muscles and pelvic floor muscle exercises. Pelvic floor muscles will be given relaxation training in 3 different relaxation positions (modified butterfly pose, child pose and deep squatting position) suggested by Çeliker Tosun et al. PFME will be taught by the physiotherapist in the side-lying with external coccyx palpation. PFME will be applied in the hook-lying position, sitting position and standing position.

Primary outcomes

  1. Change of Menstruation Symptom Scale score

    Time frame: 4 weeks after the intervention

    Individuals menstrual pain and symptoms will be assessed with the Menstruation Symptom Scale. The Turkish validity and reliability of this scale was conducted by Güvenç et al. in 2014. The MSS is a five-point Likert-type scale consisting of twenty-two items. Participants are asked to give a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints' (Items 1-13), 'Menstrual Pain Symptoms' (Items 14-19) and 'Coping Methods' (Items 20-22). The highest score that can be obtained from the scale is 110, the lowest score is 22.

  2. Change in the McGill pain questionnaire score

    Time frame: 4 weeks after the intervention

    The McGill pain questionnaire will be used to assess the severity and quality of menstrual pain in individuals. This questionnaire consists of 11 words to determine the sensory aspect of pain and 4 words to determine the affective aspect, totaling 15 different words related to the quality of pain. In addition, the pain intensity felt at the time of measurement is measured with VAS, and the total pain intensity evaluated is measured with a 6-point Likert-type scale.

Secondary outcomes

  1. Change of Menstruation Symptom Scale score

    Time frame: 3 months after the intervention

    Individuals menstrual pain and symptoms will be assessed with the Menstruation Symptom Scale. The Turkish validity and reliability of this scale was conducted by Güvenç et al. in 2014. The MSS is a five-point Likert-type scale consisting of twenty-two items. Participants are asked to give a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints' (Items 1-13), 'Menstrual Pain Symptoms' (Items 14-19) and 'Coping Methods' (Items 20-22). The highest score that can be obtained from the scale is 110, the lowest score is 22.

  2. Change of Quality of Life score

    Time frame: 4 weeks after the intervention

    Short Form-36 is a 36-question self-assessment scale consisting of eight subscales. This scale consists of physical function (10 items), role limitations (physical (4 items) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items) and general health (5 items) subscales. Each subscale is scored between 0-100, with "0" indicating the lowest and "100" indicating the best quality of life level.

  3. Change in the McGill pain questionnaire score

    Time frame: 3 months after the intervention

    The McGill pain questionnaire will be used to assess the severity and quality of menstrual pain in individuals. This questionnaire consists of 11 words to determine the sensory aspect of pain and 4 words to determine the affective aspect, totaling 15 different words related to the quality of pain. In addition, the pain intensity felt at the time of measurement is measured with VAS, and the total pain intensity evaluated is measured with a 6-point Likert-type scale.

  4. Change of Quality of Life score

    Time frame: 3 months after the intervention

    Short Form-36 is a 36-question self-assessment scale consisting of eight subscales. This scale consists of physical function (10 items), role limitations (physical (4 items) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items) and general health (5 items) subscales. Each subscale is scored between 0-100, with "0" indicating the lowest and "100" indicating the best quality of life level.

Sponsors and collaborators

Lead sponsor

Izmir University of Economics

Other

Registry information

Official study title

Investigation of the Effect of Breathing-based Pelvic Floor Muscle Training on Menstrual Symptoms, Pain and Quality of Life in Women With Primary Dysmenorrhea: A Randomized-Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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