- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06394726
Examining the Impact of Aerobic and Core Exercises on Primary Dysmenorrhea in High School Females (Dysmenorrhea)
Investigation of the Effects of Aerobic and Core Stabilization Exercises on Primary Dysmenorrhea in High School Female Students
Dysmenorrhea, derived from ancient Greek, translates to 'difficult monthly flow' and refers to painful cramps during menstruation, a common cause of pelvic pain. The pain, often in the lower abdomen, results from uterine pressure exceeding 60 mmHg. Symptoms include suprapubic pain, radiating discomfort, nausea, diarrhea, and headache, impacting quality of life. Etiology involves factors like age at menarche, heavy flow, lifestyle, and medical conditions.
Dysmenorrhea is categorized as primary (without underlying pathology) or secondary (due to conditions like endometriosis). Its prevalence is high in adolescence, affecting daily life, school, and health. Research aims to assess how aerobic and core exercises influence pain and quality of life in adolescent females (14-18 years). Participants are randomly assigned to study and control groups, exploring the potential benefits for health, well-being, and academic performance.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aycan Cakmak Reyhan, PhD
- Phone Number: +90 212 311 5338
- Email: aycan.cakmak@bilgi.edu.tr
Study Locations
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Istanbul, Turkey
- Recruiting
- Istanbul Bilgi University
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Contact:
- Aycan Reyhan, PhD
- Phone Number: +90 212 311 5338
- Email: aycan.cakmak@bilgi.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be nulliparous (have not given birth) and be between the ages of 14-18.
- Volunteer to participate.
- Have no active sexual life.
- Have a regular menstrual cycle.
- Report a pain intensity of 5 or above on the Visual Analog Scale (VAS).
- Have a Body Mass Index (BMI) between 19 and 24.9.
- Not have polycystic ovary syndrome or undergone any surgical operation related to female diseases.
- Not engage in regular exercise.
- Not have any chronic, systemic, neurological, or endocrinological diseases.
Exclusion Criteria:
- Participate in tele-rehabilitation and exercise diary for less than 3 days.
- Use an intrauterine device.
- Have taken pharmacological supplements in the last 3 months or during the study tracking period (due to reasons such as flu, COVID, etc.).
- Have any physical impediment restricting physical activity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aerobic Exercise Group
Aerobic Exercise Group For 3 months, participants will engage in a total of 150 minutes of exercise per week, either 30 minutes for 5 days a week or 50 minutes for 3 days a week.
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Aerobic and Core Stabilization Exercise Intervention
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Active Comparator: Core Stabilization Exercise Group
Core Stabilization Exercise Group for 3 months, 2 sets of exercises, each comprising 10 repetitions per set.
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Aerobic and Core Stabilization Exercise Intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: baseline and 12 weeks
|
VAS is a common tool for assessing subjective experiences like pain or mood intensity.
It consists of a 10-centimeter line with clear endpoints representing extreme sensations.
Participants mark a point on the line corresponding to their perception, such as "No Pain" to "Worst Pain Imaginable."
The distance from "No Pain" provides a quantitative measure.
Easy to administer and adaptable, VAS is widely used in clinical and research settings for various subjective states beyond pain, requiring no specialized training.
"In this scale, '0' corresponds to the best, and '10' to the worst
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baseline and 12 weeks
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Functional and Emotional functional and emotional measure of dysmenorrhea (FEMD)
Time Frame: baseline and 12 weeks
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"FEMD" stands for Functional and Emotional Measure of Dysmenorrhea.
Dysmenorrhea refers to painful menstruation, commonly known as menstrual cramps.
The FEMD is a tool or scale used to assess both the functional and emotional impacts of dysmenorrhea on individuals.
The functional aspect of the FEMD typically evaluates the severity of physical symptoms associated with dysmenorrhea, such as the intensity of pain, its duration, any associated symptoms like nausea or vomiting, and how these symptoms affect daily activities or functioning.
The scale consists of 14 items and 2 subscales.
Each item is scored on a scale from 1 to 5: (1) Not at all like my condition, (2) Not much like my condition, (3) Somewhat like and somewhat unlike my condition, (4) Much like my condition, (5) Very much like my condition.
There are no reverse items.
As scores increase on this scale, individuals' levels of functional and emotional impact from dysmenorrhea also increase."
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baseline and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SF-36 Short Form 36 Health Survey
Time Frame: baseline and 12 weeks
|
The S-F36 Health Survey is a widely used questionnaire for assessing health-related quality of life.
It measures 8 health concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations, and mental health.
These concepts are grouped into two dimensions: physical health and mental health.
Scoring is based on responses to each question in each subscale, typically ranging from 0 to 100.
Higher scores indicate better perceived physical functioning
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baseline and 12 weeks
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A dysmenorrhea monitoring form
Time Frame: baseline and 12 weeks
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A dysmenorrhea monitoring form typically includes various aspects related to menstrual pain and associated symptoms.
Here's an example of a dysmenorrhea monitoring form.
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baseline and 12 weeks
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Dysmenorrhea Impact Scale short form
Time Frame: baseline and 12 weeks
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The "Dismenorrhea Impact Scale" is a tool used to assess the functional and emotional symptoms associated with dysmenorrhea (menstrual pain).
This scale evaluates individuals' limitations in daily life activities and the emotional distress they experience due to menstrual pain.This scale serves as an important tool in determining the impact of menstrual pain on individuals' quality of life and in developing appropriate treatment strategies.The scale does not contain reverse items.
It is a five-point Likert scale, scored as follows: Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), Strongly Agree (5).
The first 8 items belong to the cognitive/emotional subscale, while the last 5 items fall within the physiological subscale.
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baseline and 12 weeks
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Menstrual Symptom Questionnaire
Time Frame: baseline and 12 weeks
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MAS is a tool used to assess individuals' attitudes towards menstruation.
It measures beliefs, feelings, and behaviors related to menstruation.
The scale typically consists of a series of statements or items, to which individuals respond based on their agreement or disagreement.Due to the difficulty in adapting the original 7-point Likert scale assessment form into Turkish, the Turkish version of the scale has been converted to a 5-point evaluation form ranging from 1 to 5 (1.
Strongly Disagree, 2. Disagree, 3. Neutral, 4. Agree, 5. Strongly Agree).
Higher average scores obtained from items, subgroups, or the entire scale indicate a "positive" attitude towards menstruation.
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baseline and 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aycan Cakmak Reyhan, PhD, Istanbul Bilgi University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- İstanbulBilgiiiU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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