ExerciseNCT06860256
Different Exercise Training Programs in University Students with Primary Dysmenorrhea
A study testing Basic Body Awareness Therapy, High Intensity Interval Training and Classic Exercise and Lifestyle Tips in people with Exercise and Primary Dysmenorrhea, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Exercise, Primary Dysmenorrhea
- What is being tested?
- Basic Body Awareness Therapy, High Intensity Interval Training and Classic Exercise and Lifestyle Tips
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2025to 25 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kilis 7 Aralık University
Kilis, Province
Gizem Tas Gecit, lecturer, +90348 814 26 66, gizem.tasgecit@kilis.edu.tr
About this study
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
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.
Read the 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
- Being tested
- Basic Body Awareness Therapy, High Intensity Interval Training, Classic Exercise and Lifestyle Tips
- Keywords
- primary dysmenorrhea, exercises
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Body Awareness TherapyOther
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 TrainingOther
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.
Classic Exercise and Lifestyle TipsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Classic Exercise and Lifestyle Tips |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Two months
Secondary outcomes (9)
Information About Menstruation
To determine characteristics related to menstruation,if use of medication during menstruation, including the name, dose, amount, and timing of the medication. Additionally, individuals were assessed for the presence and severity of systemic symptoms related to menstruation.The severity of these symptoms was rated as follows: 0: None, 1: Mild, 2: Moderate, 3: Severe. This evaluation was conducted on the first day of the 1st, 2nd, and 3rd menstruation cycles.
Measured: Two months
Short-form McGill Pain Questionnaire
A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Measured: Two months
Pittsburgh Sleep Quality Index
The PSQI evaluates sleep quality and disturbances over a one-month period and consists of seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The score of each component ranges 0-3 and the global score is the sum of scores for these seven components with a range of 0-21. The global score of more than 5 indicates poor sleep quality. Developers have suggested that a global PSQI score > 5 yields a diagnostic sensitivity of 89.6% and a specificity of 86.5% in distinguishing patients with sleep problems from healthy controls in their validation study.
Measured: Two months
Epworth Sleepiness Scale
The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. The questionnaire takes no more than 2 or 3 minutes to answer.
Measured: Two months
The Stroop Test Çapa Form
The Stroop Test is commonly used to evaluate executive functions such as selective attention and resistance to interference. The Stroop Test Çapa Form consists of three sub-sections: Stroop A, Stroop B, and Stroop C. The test involves two stimulus cards.On the first card, there are boxes in red, green, and blue colors. In the Stroop A section, the individual is asked to name the colors of the boxes as quickly as possible, following a left-to-right sequence.The second stimulus card contains the words "red," "green," and "blue" written in red, green, and blue ink colors, but the ink color and the word meaning are mismatched (e.g., the word "red" written in blue ink, the word "green" written in red ink).In the Stroop B section, the individual is asked to read the color names on this second card as quickly as possible.In the Stroop C section, instead of reading the words, the individual is instructed to name the ink color of the words as quickly as possible. During this task, the individu
Measured: Two months
State - Trait Anxiety Inventory-STAI
The STAI state scale isscored on four levels of anxiety intensity from1 ¼ 'not at all' to 4 ¼ 'very much' and with a sumscore between 20 and 80. It is usually administeredas a self-completion questionnaire. The 20 items aredivided into two groups: ten items are formed torecord the presence of anxiety symptoms and theother ten items are scored to record the absence ofanxiety symptoms.
Measured: Two months
Heart Rate Varıabılıty Measurement To Assess Stress Level Wıth Apple Watch
For Apple Watch users 18 and older, HRV is automatically recorded with Apple Watch (in most countries). However, you need to head to the Health app on iPhone to look at the data.Open the Health app on iPhone, tap the Browse tab in the bottom right corner, now choose Heart > Heart Rate Variability,At the top, you can change the HRV data view by day. HRV is measured manually with the Apple Watch while resting and always at the same time.
Measured: Two months
Perceived Stress Scale-10
The ASQ-10 scale a total of 10 items, the PSS-10 was created to measure the level of stress perceived by the individual in situations encountered in life. On a five-point Likert-type scale, participants rate each item from "Never (0)" to "Very often (4)". Items with positive statements (items 4,5,7,8) are reverse scored. A high score on the ASQ-10 scale, whose total score ranges between 0 and 40, indicates that the person's stress perception is high. The ASQ-10 scale was adapted into Turkish by Eskin et al.
Measured: Two months
Academic Stress Scale
The 27-item scale aims to measure the general academic stress levels of university students. It consists of four sub-dimensions: difficulties in the classroom, difficulties outside the classroom, difficulties in interacting with the university and difficulties in managing different areas. The first six items of the scale belong to the difficulties in the classroom sub-dimension. The next eight items of the scale (items 7-14) belong to the difficulties outside the classroom sub-dimension. The other eight items of the scale (items 15-22) belong to the difficulties in interacting with the university sub-dimension. The last five items of the scale (items 23-27) belong to the difficulties in managing different domains sub-dimension.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start25 Feb 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion25 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exercise intervention in three groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Tas Gecit, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860256
- Sponsor's protocol ID
- HasanKU-FTR-GTG-01
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I want my work to be published on international platforms.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06860256
- Acronym / sponsor ID
- HasanKU-FTR-GTG-01
- Conditions
- Exercise, Primary Dysmenorrhea
- Keywords
- primary dysmenorrhea, exercises
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 25 Feb 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 25 Oct 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Exercise intervention in three groups
| Arm | Type | Receives |
|---|---|---|
| Basic Body Awareness Therapy | Active comparator | Other: Basic Body Awareness TherapyBasic 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. |
| High Intensity Interval Training (HIIT) | Active comparator | Other: High Intensity Interval TrainingHigh 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. |
| Classical Exercise (CE) and Lifestyle Recommendations (LSS) | Active comparator | Other: Classic Exercise and Lifestyle TipsClassical 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Body Awareness TherapyIn 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. | Other | Basic Body Awareness Therapy |
| High Intensity Interval TrainingTabata 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. | Other | High Intensity Interval Training (HIIT) |
| Classic Exercise and Lifestyle TipsClassical 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. | Other | Classical Exercise (CE) and Lifestyle Recommendations (LSS) |
Primary outcome
Sociodemographic information
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
9 secondary outcomes
Information About Menstruation
Time frame: Two months
Short-form McGill Pain Questionnaire
Time frame: Two months
Pittsburgh Sleep Quality Index
Time frame: Two months
Epworth Sleepiness Scale
Time frame: Two months
The Stroop Test Çapa Form
Time frame: Two months
State - Trait Anxiety Inventory-STAI
Time frame: Two months
Heart Rate Varıabılıty Measurement To Assess Stress Level Wıth Apple Watch
Time frame: Two months
Perceived Stress Scale-10
Time frame: Two months
Academic Stress Scale
Time frame: Two months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Yes. I want my work to be published on international platforms.
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Obesity, Overweight
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Body Awareness Therapy, High Intensity Interval Training and Classic Exercise and Lifestyle Tips in people with Exercise and Primary Dysmenorrhea, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gizem Tas Gecit, doctoral thesis student (+905060293027, fztgizem91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic information (time frame: Two months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.