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临床试验/NCT06860256
NCT06860256尚未招募不适用

Comparison of the Effects of Different Exercise Training Programs on Dysmenorrhea Symptoms, Sleep and Quality of Life in University Students with Primary Dysmenorrhea

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Sociodemographic information

研究概览

简要总结

Dysmenorrhea is severe lower abdominal pain in women during menstruation. The pain is usually cramping and can radiate to the thighs or lower spine. Lower abdominal pain may be accompanied by vomiting, headache, back pain, diarrhea, fatigue, etc. Depending on the pathophysiology, dysmenorrhea is classified into two types: primary and secondary. Primary dysmenorrhea (PD) is menstrual pain associated with normal ovulatory cycles in the absence of pelvic pathology and a clear physiologic etiology and is most commonly seen in adolescents and young adults. There are numerous studies on PD in the literature, but there is still a lack of studies on which of the non-pharmacologically recommended exercise and other methods is more effective on dysmenorrhea symptoms, sleep and quality of life for individuals with this problem. Different exercise intensities may affect PD symptoms through different mechanisms. Moderate to high intensity exercise may reduce pain by increasing anti-inflammatory cytokines, whereas less intense exercise, such as yoga, affects pain levels by decreasing cortisol levels. The lack of research on which exercise training is more effective in PD individuals was considered as a limitation. In the light of this information, the aim of the investigators study is to compare the effects of different training techniques on dysmenorrhea symptoms, sleep and quality of life in PD treatment and to present the preferability of these techniques based on evidence.

详细描述

Dysmenorrhea is severe lower abdominal pain in women during menstruation. The pain is usually cramping and can radiate to the thighs or lower spine. Lower abdominal pain may be accompanied by vomiting, headache, back pain, diarrhea, fatigue, etc. Depending on the pathophysiology, dysmenorrhea is classified into two types: primary and secondary. Primary dysmenorrhea (PD) is menstrual pain associated with normal ovulatory cycles in the absence of pelvic pathology and a clear physiologic etiology and is most common in adolescents and young adults. Secondary dysmenorrhea is menstrual pain associated with an identifiable disease (endometriosis, fibroids, adenomyosis, pelvic adhesions, polyps in the endometrium, pelvic inflammatory disease) or intrauterine contraceptive use. PD usually occurs only one or two years after menarche. Menstrual pain starts a few hours before or during menstruation and lasts for 2-3 days. The pain is most severe in the first 24-36 hours of menstruation.

According to the World Health Organization, 94% of girls aged 10-20 and 8.8% of women aged 19-41 suffer from menstrual cramps.It has been observed that dysmenorrhea can significantly reduce quality of life and cause absenteeism from school and work. There are different approaches to the treatment of PD. Pharmacologically, treatment is achieved through hormonal medications such as prostoglandin inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), prostoglandin inhibitors and birth control pills. Non-pharmacologically, alternative conservative treatment methods such as acupuncture and acupressure, biofeedback, heat therapies, transcutaneous electrical nerve stimulation (TENS), exercises and relaxation techniques are used because they are safe and easy to implement. PD exercise protocols include relaxation, strengthening, stretching, aerobic exercises, pelvic floor muscle strengthening exercises, yoga and pilates. Studies have shown that long-term aerobic exercises, stretching exercises and yoga relieve the symptoms of dysmenorrhea and reduce the severity of pain, but it is not known which treatment option is more effective.The investigators study will be planned as a randomized controlled trial. PD is a disease group with a high incidence especially in the 18-25 age group. Hormonal pharmacologic treatments are generally used in these patients. Although these treatments reduce symptoms, they may lead to serious contraindications in the future. In the investigators study, we aim to present the effects of Basic Body Awareness Therapy, High Intensity Interval Training, Classical exercise training and lifestyle recommendations on parameters such as dysmenorrhea symptoms, sleep and quality of life.

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
Single (Participant)

盲法说明

We aim to present the effects of Basic Body Awareness Therapy, High Intensity Interval Training and Classical exercise training and lifestyle recommendations on parameters such as dysmenorrhea symptoms, sleep and quality of life.

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

  • •Nulliparous female university students aged 18-25 years who volunteered to participate in the study, met the criteria specified in the PD Consensus Guidelines and were diagnosed with PD by a gynecologist
  • •Individuals with a body mass index (BMI) between 18-35
  • •Individuals with a regular menstrual cycle (28 ± 7 days)
  • •Individuals with menstrual pain Visual Analog Scale (VAS) score of 4 cm or higher for the last 6 months

排除标准

  • •Gastrointestinal, urogynecologic, autoimmune, psychiatric, neurological diseases or other chronic pain syndromes
  • •Having given birth and/or being pregnant
  • •Intrauterine device users
  • •Pelvic surgery patients
  • •Taking oral contraceptives or medication, including antidepressants, for at least 6 months before the study
  • •Those with a pathological history or ultrasonography result indicating secondary dysmenorrhea
  • •Those who use alternative treatment methods and exercise regularly
  • •Serious traumatic life events that occurred in the three months prior to the start of the study
  • •Communication problems that may interfere with the implementation of assessments and/or treatment program

研究组 & 干预措施

Basic Body Awareness Therapy

Active Comparator

Basic Body Awareness Therapy (TBFT) is a physiotherapy modality that focuses on improving the health and well-being of patients with mental health problems and/or psychosomatic and chronic pain, long-term musculoskeletal and neurological disorders. In TBFT sessions, physiotherapists improve the patient's contact with "self" by focusing on basic movement principles while performing simple daily movements such as lying, sitting, standing, walking, use of sound and massage. Mental awareness, postural balance and free breathing are considered key elements. The pparticipants is invited to explore and integrate flow, rhythm and intentionality in coordinated movements in relation to time, space and energy. TBFT is practiced 2 days a week, 60 minutes, 5-12 weeks, depending on the patient.

干预措施: Basic Body Awareness Therapy (Other)

High Intensity Interval Training (HIIT)

Active Comparator

High Intensity Interval Training (HIT) is a protocol filled with exercises that challenge the body and increase the heart rate, unlike normal cardio methods. The most commonly used of these protocols is the Tabata protocol. The Tabata protocol involves the re-synthesis of ATP through anaerobic and aerobic processes during high intensity exercises lasting more than a few seconds. Tabata can be done on a running track, in nature, in water, in a gym or with training aids such as stationary bicycles, jump ropes, sandbags, etc. HWCA improves metabolic functions and cardiovascular system. Recent studies have shown that High intensity interval training improves adaptation, health and performance parameters in athletes and individuals with a normal lifestyle (sedentary).Tabata exercise protocol is an 8 repetition training program with 20 seconds of work and 10 seconds of rest. Warm-up and cool-down exercises of 5 minutes each should be performed to prevent injuries and negativities.

干预措施: High Intensity Interval Training (Other)

Classical Exercise (CE) and Lifestyle Recommendations (LSS)

Active Comparator

Classical Exercise (CE) and Lifestyle Recommendations (LSS), classical exercises used in PD include abdominal, pelvic floor muscles, hip flexors, and whole body stretches (13).Non-pharmaceutical strategies for pain management in LSS include adopting relaxation (rest, warm-up, massage, music, etc.), antalgic positions, and distraction techniques. Common techniques that facilitate relaxation and thus reduce pain include physical rest, various heat applications such as hot showers, thermal seed packs, electric blankets, and drinking warm herbal teas such as chamomile tea.

干预措施: Classic Exercise and Lifestyle Tips (Other)

结局指标

主要结局

Sociodemographic information

时间窗: Two months

Sociodemographic information, physical and other medical information about the individuals' age, weight and height will be combined to report BMI in kg/m\^2 and general information about menstrual symptoms and cycles were recorded.

Menstrual Symptom Scale

时间窗: Two months

The scale consists of 22 items and is five-point Likert type. Items 1-13 belong to "Negative effects/somatic complaints" subdimension, items 14-19 belong to "Menstrual pain symptoms" sub-dimension and items 20-22 belong to "Coping methods" subdimension. The Menstrual Symptom Scale score is calculated by averaging the total score of the items in the scale. Participants are asked to assign a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. An increase in the mean score indicates an increase in the severity of menstrual symptoms. The scale has three subdimensions. The score obtained from the subscales is calculated by averaging the total score of the items in the subscales. An increase in the mean score for the sub-dimensions indicates an increase in the severity of menstruation.

The Menstrual Attitude Questionnaire

时间窗: Two months

The Menstrual Attitude Questionnaire, is in Likert format and is rated on a scale from 1 to 7. The reliability coefficient of the original scale ranges from 0.95 to 0.97. In the Menstrual Attitude Questionnaire, higher average scores from the items, subgroups, or the overall scale indicate a "positive" attitude towards menstruation.

Evaluation of Quality of Life Short Form-12

时间窗: Two months

Evaluation of Quality of Life Short Form-12: This questionnaire was used to evaluate quality of life, which includes 12 questions about eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. Scoring uses the RAND system from zero to 100. The score of each domain is obtained by aggregating the question scores in every domain and dividing the resulting number by the number of questions in the same domain. A higher score indicates better quality of life.The validity and reliability of the questionnaire are approved

次要结局

  • Information About Menstruation(Two months)
  • Short-form McGill Pain Questionnaire(Two months)
  • Pittsburgh Sleep Quality Index(Two months)
  • Epworth Sleepiness Scale(Two months)
  • The Stroop Test Çapa Form(Two months)
  • Perceived Stress Scale-10(Two months)
  • State - Trait Anxiety Inventory-STAI(Two months)
  • Heart Rate Varıabılıty Measurement To Assess Stress Level Wıth Apple Watch(Two months)
  • Academic Stress Scale(Two months)

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gizem Tas Gecit

PhD student

Hasan Kalyoncu University

研究点 (1)

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