Clinical trial NCT06860256: Different Exercise Training Programs in University Students with Primary Dysmenorrhea
Official title: Comparison of the Effects of Different Exercise Training Programs on Dysmenorrhea Symptoms, Sleep and Quality of Life in University Students with Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exercise
Primary Dysmenorrhea
Keywords: primary dysmenorrhea
exercises
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Exercise intervention in three groups
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sociodemographic information
timeFrame: Two months
measure: Menstrual Symptom Scale
timeFrame: Two months
measure: The Menstrual Attitude Questionnaire
timeFrame: Two months
measure: Evaluation of Quality of Life Short Form-12
timeFrame: Two months
Secondary outcomes:
measure: Information About Menstruation
timeFrame: Two months
measure: Short-form McGill Pain Questionnaire
timeFrame: Two months
measure: Pittsburgh Sleep Quality Index
timeFrame: Two months
measure: Epworth Sleepiness Scale
timeFrame: Two months
measure: The Stroop Test Çapa Form
timeFrame: Two months
measure: State - Trait Anxiety Inventory-STAI
timeFrame: Two months
measure: Heart Rate Varıabılıty Measurement To Assess Stress Level Wıth Apple Watch
timeFrame: Two months
measure: Perceived Stress Scale-10
timeFrame: Two months
measure: Academic Stress Scale
timeFrame: Two months
Other outcomes:
Locations:
city: Kilis
country: Turkey
facility: Kilis 7 Aralık University
state: Province
Study officials:
References: