Pelvic Floor and Diaphragmatic Breathing Exercises for Primary Dysmenorrhea

Официальное название

Effects of Combined Pelvic Floor and Diaphragmatic Breathing Exercises on Primary Dysmenorrhea

Обзор

This study investigates whether combining pelvic floor muscle exercises with diaphragmatic breathing exercises can reduce menstrual pain in women with primary dysmenorrhea. Forty participants will be randomly assigned to two groups: one performing both exercises, and the other performing only diaphragmatic breathing. The study will measure pain, menstrual symptoms, quality of life, and psychological well-being before and after the intervention.

Подробное описание

This interventional study aims to investigate the combined effects of pelvic floor muscle exercises and diaphragmatic breathing exercises on primary dysmenorrhea in women. The study is designed based on a biopsychosocial model to explore both physical and psychological outcomes of the intervention.

A total of 40 participants will be recruited and randomly assigned to two groups. The intervention group will perform a program combining pelvic floor and diaphragmatic breathing exercises, while the control group will perform only diaphragmatic breathing exercises. The exercise program will be conducted over a specified period, with sessions scheduled regularly according to the study protocol.

Assessments will be conducted twice: prior to and after the menstrual period. Pain intensity will be evaluated using the Visual Analog Scale (VAS), and pain threshold will be measured with a pressure algometer. Menstrual and premenstrual symptoms, quality of life, sleep quality, and psychological status, including depression, anxiety, and stress levels, will be assessed using validated scales such as the PMS Scale, SF-36, DASS-21, and PUKI.

This study is expected to provide scientific evidence for physiotherapy interventions in women's health and offer an alternative non-pharmacological approach for managing primary dysmenorrhea. By addressing both physical and psychological aspects, the exercise program may reduce pain, improve quality of life, and enhance overall well-being in participants.

Вмешательства

• Поведенческое Pelvic Floor + Breathing Exercises
  Participants will perform both pelvic floor and diaphragmatic breathing exercises according to the study protocol. Assessments will focus on pain, quality of life, and psychological measures.
• Поведенческое Diaphragmatic Breathing Exercises
  Participants will perform only diaphragmatic breathing exercises. Assessments will be conducted in the same manner.

Первичные конечные точки

• Pain intensity (Visual Analog Scale, VAS) [Срок оценки: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).]
• Pain Threshold (Pressure Algometer) [Срок оценки: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).]
• Menstrual Symptoms (Menstrual Symptom Scale - MSS) [Срок оценки: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).]
• Premenstrual Symptoms (PMS Scale) [Срок оценки: One week before menstruation]

Вторичные конечные точки (3)

• Quality of Life (SF-36) [Срок оценки: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).]
• Sleep Quality (Pittsburgh Sleep Quality Index - PSQI) [Срок оценки: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).]
• Depression, Anxiety, and Stress (DASS-21) [Срок оценки: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).]

Критерии участия

Критерии включения

• Aged 18 years or older
• Diagnosed with primary dysmenorrhea (PD)
• Having regular menstrual cycles for the past 6 months
• Willing to participate in the study

Критерии исключения

• Diagnosis of secondary dysmenorrhea
• Irregular menstrual cycles (less than 21 days or more than 35 days)
• History of childbirth or previous pregnancy
• Currently pregnant
• Presence of any neurological, systemic, or psychiatric chronic disease
• Regular use of medications in the past 6 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Gelişim University — Istanbul

Публикации

• Dixon JS, Bird HA. Reproducibility along a 10 cm vertical visual analogue scale. Ann Rheum Dis. 1981 Feb;40(1):87-9. doi: 10.1136/ard.40.1.87. PMID 7469530
• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PMID 2748771
• Brown TA, Chorpita BF, Korotitsch W, Barlow DH. Psychometric properties of the Depression Anxiety Stress Scales (DASS) in clinical samples. Behav Res Ther. 1997 Jan;35(1):79-89. doi: 10.1016/s0005-7967(96)00068-x. PMID 9009048
• ACOG Committee Opinion No. 760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018 Dec;132(6):e249-e258. doi: 10.1097/AOG.0000000000002978. PMID 30461694

Идентификаторы

NCT: NCT07263516 · IstanbulGelisimU-FTR-IK-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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