Different Exercise Training Programs in University Students with Primary Dysmenorrhea

NCT06860256 | Not Yet Recruiting

• 1 other identifier: HasanKU-FTR-GTG-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Primary Dysmenorrhea

Keywords

primary dysmenorrhea; exercises

Outcome Measures

Primary Outcomes (4)

• Sociodemographic information

  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.

  Two months

• Menstrual Symptom Scale

  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.

  Two months

• The Menstrual Attitude Questionnaire

  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.

  Two months

• Evaluation of Quality of Life Short Form-12

  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

  Two months

Secondary Outcomes (9)

• 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

Study Arms (3)

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.

Other: Basic Body Awareness Therapy

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.

Other: High Intensity Interval Training

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.

Other: Classic Exercise and Lifestyle Tips

Interventions

Basic Body Awareness Therapy 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.

Basic Body Awareness Therapy

High Intensity Interval Training 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.

High Intensity Interval Training (HIIT)

Classic Exercise and Lifestyle Tips 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.

Classical Exercise (CE) and Lifestyle Recommendations (LSS)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Kilis 7 Aralık University

Kilis, Province, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Gizem Tas Gecit, doctoral thesis student

CONTACT

+905060293027; fztgizem91@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Exercise intervention in three groups

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 6, 2025
• Study Start: February 25, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 25, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 30 years

Locations

TU (1)