Effects of Combined Pelvic Floor and Diaphragmatic Breathing Exercises on Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain intensity (Visual Analog Scale, VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. No participants, care providers, investigators, or outcome assessors are blinded to group assignments.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 1: Intervention group → Pelvic floor + diaphragmatic breathing exercises
Participants will perform a combined program of pelvic floor muscle exercises and diaphragmatic breathing exercises. The exercises will be conducted according to the study protocol, with sessions scheduled regularly over the intervention period. Both physical and psychological outcomes will be assessed before and after the menstrual period.
干预措施: Pelvic Floor + Breathing Exercises (Behavioral)
Arm 2: Control group: Diaphragmatic breathing exercises
Participants will perform only diaphragmatic breathing exercises according to the study protocol. Assessments of pain, menstrual symptoms, quality of life, sleep quality, and psychological measures will be conducted before and after the menstrual period.
干预措施: Diaphragmatic Breathing Exercises (Behavioral)
结局指标
主要结局
Pain intensity (Visual Analog Scale, VAS)
时间窗: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
Pain severity will be assessed using a 100-mm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will mark their perceived pain level, which will then be measured with a ruler to obtain a numerical value.
Pain Threshold (Pressure Algometer)
时间窗: 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 will be assessed at six anatomical points using a pressure algometer. Pressure is gradually increased until participants report pain. Two measurements per point are recorded, with the mean value calculated in lbs/cm².
Menstrual Symptoms (Menstrual Symptom Scale - MSS)
时间窗: 1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).
The severity of menstrual symptoms will be assessed using the Menstrual Symptom Scale (MSS), whose Turkish validity and reliability were established by Güvenç, Seven, and Akyüz (2014). The scale consists of 22 items, each rated on a 5-point Likert scale from 1 ("never") to 5 ("always"). Minimum possible total score: 22 points Maximum possible total score: 110 points
Premenstrual Symptoms (PMS Scale)
时间窗: One week before menstruation
Premenstrual symptoms will be assessed using the 44-item PMS Scale, covering nine subscales such as depressive mood, anxiety, fatigue, irritability, pain, sleep, and appetite changes. The total score of the scale is obtained by summing the scores from all subscales, ranging from 44 to 220 points. Higher scores indicate a greater severity of premenstrual syndrome (PMS) symptoms.
次要结局
- Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)(1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).)
- Quality of Life (SF-36)(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)(1-2 days before the onset of menstruation (pre-menstrual assessment) and 1-2 days after the end of menstruation (post-menstrual assessment).)
研究者
Irmak KARDEŞ
Graduate Student
Istanbul Gelisim University