Different Exercise Training Programs in University Students with Primary Dysmenorrhea

NCT ID: NCT06860256

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2025-10-25

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.

Conditions

Exercise; Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Basic Body Awareness Therapy

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.

Group Type: ACTIVE_COMPARATOR

Basic Body Awareness Therapy

Intervention Type: OTHER

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 patient 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.

High Intensity Interval Training (HIIT)

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.

Group Type: ACTIVE_COMPARATOR

High Intensity Interval Training

Intervention Type: OTHER

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 done to prevent injuries and negativities. Although the application varies according to the patient, YŞİA is applied 2 days a week, 15-30 minutes, in processes ranging between 2-12 weeks.

Classical Exercise (CE) and Lifestyle Recommendations (LSS)

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.

Group Type: ACTIVE_COMPARATOR

Classic Exercise and Lifestyle Tips

Intervention Type: OTHER

Classical Exercise (CE) and Lifestyle Recommendations (LSR), Classical exercises used in PD include abdominal, pelvic floor muscles, hip flexors, whole body stretching. Non-pharmaceutical strategies for pain management in LRS 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, hot showers, various heat applications such as thermal seed bags, electric blankets, and drinking hot herbal teas such as chamomile tea.

Interventions

Basic Body Awareness Therapy

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 patient 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.

Intervention Type: OTHER

High Intensity Interval Training

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 done to prevent injuries and negativities. Although the application varies according to the patient, YŞİA is applied 2 days a week, 15-30 minutes, in processes ranging between 2-12 weeks.

Intervention Type: OTHER

Classic Exercise and Lifestyle Tips

Classical Exercise (CE) and Lifestyle Recommendations (LSR), Classical exercises used in PD include abdominal, pelvic floor muscles, hip flexors, whole body stretching. Non-pharmaceutical strategies for pain management in LRS 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, hot showers, various heat applications such as thermal seed bags, electric blankets, and drinking hot herbal teas such as chamomile tea.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hasan Kalyoncu University

OTHER

Sponsor Role: lead

Responsible Party

Gizem Tas Gecit

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kilis 7 Aralık University

Kilis, Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Gizem Tas Gecit, doctoral thesis student

Role: CONTACT

fztgizem91@gmail.com

+905060293027

Facility Contacts

Gizem Tas Gecit, lecturer

Role: primary

gizem.tasgecit@kilis.edu.tr

+90348 814 26 66

Other Identifiers

HasanKU-FTR-GTG-01

Identifier Type: -

Identifier Source: org_study_id