Primary DysmenorrheaNCT06518525
The Effects Of Pilates-Based Tele-Exercise In Primary Dysmenorrhea
A study testing pilates-based tele-exercises in people with Primary Dysmenorrhea, run by Derya Azim at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators will aim to investigate the effects of Pilates-based tele-exercise on the physical and mental health of women with primary dysmenorrhea. The study will include 22 volunteers diagnosed with primary dysmenorrhea. Participants will be randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- pilates-based tele-exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between 18-30 years old,
- Diagnosed with primary dysmenorrhea during an ultrasound examination,
- Having a PD pain score of 4-7 cm on the Visual Analog Scale (VAS),
- Being able to attend Pilates sessions twice a week,
- Not engaging in regular exercise,
- Having a regular menstrual cycle (30-35 days) and a bleeding duration of 3-10 days,
Who cannot join
- Being pregnant,
- Having serious comorbidities (neurological, cardiovascular, and musculoskeletal disorders),
- Not willing to participate in the study,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma Onyedi Eylul University
Balıkesir, Bandırma
About this study
Official title: The Effects Of Pilates-Based Tele-Exercise On Physical And Mental Health In Primary Dysmenorrhea
In this study, the investigators will aim to investigate the effects of Pilates-based tele-exercise on the physical and mental health of women with primary dysmenorrhea. The study will include 22 volunteers diagnosed with primary dysmenorrhea. Participants will be randomly divided into two groups. The first group will undergo Pilates-based tele-exercises (6 weeks/2 days/50 minutes) (PTTE, n=11). The second group will be a non-intervention control group (CG, n=11). Pain severity will be assessed using the Visual Analog Scale (VAS), and menstrual information will be evaluated using the Menstrual Symptom Questionnaire (MSQ), Menstrual Attitude Questionnaire (MAQ), and Functional and Emotional Dysmenorrhea Scale (FEDS). Quality of life will be assessed using the Nottingham Health Profile (NHP).
Read the detailed description
In this study, the investigators will aim to investigate the effects of Pilates-based tele-exercise on the physical and mental health of women with primary dysmenorrhea. The study will include 22 volunteers diagnosed with primary dysmenorrhea. Participants will be randomly divided into two groups. The first group will undergo Pilates-based tele-exercises (6 weeks/2 days/50 minutes) (PTTE, n=11). The second group will be a non-intervention control group (CG, n=11). Pain severity will be assessed using the Visual Analog Scale (VAS), and menstrual information will be evaluated using the Menstrual Symptom Questionnaire (MSQ), Menstrual Attitude Questionnaire (MAQ), and Functional and Emotional Dysmenorrhea Scale (FEDS). Quality of life will be assessed using the Nottingham Health Profile (NHP).Inclusion criteria were determined as follows: being between 18-30 years old, diagnosed with primary dysmenorrhea during an ultrasound examination, having a PD pain score of 4-7 cm on the Visual Analog Scale (VAS), being able to attend Pilates sessions twice a week, not engaging in regular exercise, and having a regular menstrual cycle (30-35 days) and bleeding duration (3-10 days). Exclusion criteria included being pregnant, having serious comorbidities (neurological, cardiovascular, and musculoskeletal disorders), and not willing to participate in the study. Volunteers who agree to participate in the study will sign an informed consent form, after which they will be given the necessary information about the scales used in the assessment. The scales will be filled out by the participants based on their previous menstrual experiences. After the assessment, Pilates-based tele-rehabilitation exercises will be applied for 6 weeks. At the end of the 6 weeks, assessments will be repeated in both groups. The scales applied to both groups before and after the study will be uploaded to the Google Forms database and sent to the participants.
- Conditions
- Primary Dysmenorrhea
- Being tested
- pilates-based tele-exercises
- Keywords
- Primary Dysmenorrhea, Menstruation, Pain, Tele-Exercise, pilates
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pilates-based tele-exercisesOther
pilates-based tele-exercises
| Study group | Role | What they receive |
|---|---|---|
| pilates-based tele-exercises | Experimental | Participants in the primary dysmenorrhea study group will be given a general introduction to Pilates-based tele-exercises, and they will be taught five essential elements that they should continuously practice during the exercise process. These elements will be control, breathing, fluidity, precision, and centering. They will be instructed on how to activate the core muscles, including the transverse abdominis, pelvic floor, and multifidus muscles, through isometric contractions while exhaling (centering). The exercises will be conducted over 6 weeks, twice a week, with each session lasting 50 minutes. The exercises, predetermined by the researcher, will be performed under the supervision of a physiotherapist. Each session will be structured into warm-up exercises, main exercises, and cool-down exercises. . Receives: Other: pilates-based tele-exercises |
| control group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sure, here is the English translation: Visual Analog Scale
The Visual Analog Scale (VAS) was used to assess pain in the study. The VAS is a horizontal or vertical line that is 10 cm in length. At the beginning of the line, the phrase "no pain" is placed, and at the end, "unbearable pain" is written. Participants are asked to mark the point on the line that corresponds to the severity of the pain they experience. The distance between the point where the VAS value is the lowest and the point where the patient marked is measured, and the numerical value corresponding to the pain severity is recorded
Measured: Baseline and 6 weeks later
Nottingham Health Profile
The Nottingham Health Profile (NHP) is a quality of life assessment questionnaire developed in 1987 to determine the degree to which individuals' perceived health problems affect their daily activities. The Turkish version of the scale was developed and psychometrically evaluated by Küçükdeveci et al. The NHP consists of six sub-dimensions: pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), physical activity (8 items), and energy (3 items). The questionnaire is answered with 'yes' or 'no'. Each section of the questionnaire is calculated separately; the sub-dimension score is obtained by summing the 'yes' responses to the items in each sub-dimension and dividing by the number of items in that sub-dimension, then multiplying by 100. Each sub-dimension scores between 0 and 100, with higher scores indicating lower quality of life
Measured: Baseline and 6 weeks later
Menstrual Symptom Questionnaire
he Menstrual Symptom Questionnaire (MSQ) was developed in English by Chesney and Tasto in 1975 to assess pain and other symptoms associated with menstruation. The Turkish validity and reliability were completed by Güvenç et al. in 2014. The scale consists of 24 items in total, in a 5-point Likert-type format. It includes three sub-dimensions: 'Negative Effects/Somatic Complaints' (13 items), 'Pain Symptoms' (6 items), and 'Coping Methods' (3 items). Participants are asked to rate the symptoms they experience during menstruation as 1 (never), 2 (rarely), 3 (sometimes), 4 (often), and 5 (always). The score for each sub-dimension is calculated as the average of the total points of the items in that sub-dimension. The total score of the MSQ is calculated by averaging the total points of all scale items; higher scores indicate greater severity of menstrual symptoms.
Measured: Baseline and 6 weeks later
Menstrual Attitude Questionnaire
The Menstrual Attitude Questionnaire (MAQ) was developed by Brooks-Gunn and Ruble in 1980, and its validity and reliability in Turkey were established by Kulakaç et al. in 2008. The Turkish version of the MAQ consists of 33 items and five sub-scales in a Likert-type format. These sub-scales are 'Menstruation as a debilitating event' (12 items), 'Menstruation as a bothersome event' (6 items), 'Menstruation as a natural event' (5 items), 'Anticipation and prediction of menstruation' (5 items), and 'Denial of menstruation effects' (7 items). Participants are asked to select one of the following options for each question: 1. Strongly disagree, 2. Disagree, 3. Neutral, 4. Agree, and 5. Strongly agree. Higher average scores from the items, sub-dimensions, or the entire scale indicate a more positive attitude towards menstruation.
Measured: Baseline and 6 weeks later
Functional and Emotional Dysmenorrhea Scale
The Functional and Emotional Dysmenorrhea Scale (FEDS) is used to measure functional and emotional health in dysmenorrhea. It was developed by Li et al. in 2012, and its Turkish validity and reliability were established by Gün in 2014. The FEDS consists of 14 items in total, with two sub-dimensions: functional dysmenorrhea and emotional dysmenorrhea. Participants are asked to choose the option that best describes their condition for each item: 1. Does not resemble my condition at all, 2. Does not quite resemble my condition, 3. Both resembles and does not resemble my condition, 4. Somewhat resembles my condition, 5. Very much resembles my condition. Higher scores indicate greater functional and emotional impact from dysmenorrhea.
Measured: Baseline and 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Aug 2024
- Primary completion30 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derya Azim
- Sponsor type
- University, hospital or other
- Collaborators
- Okan University
- Responsible party
- Sponsor-investigator, Derya Azim, Bandırma Onyedi Eylül University
- Investigators
- Emine Atıcı, Principal investigator, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518525
- Sponsor's protocol ID
- B.30.2.AYD.0.00.00
- Status last verified
- Feb 2025
- First submitted
- 19 Jul 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available for use by other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Pilates-Based Tele-Exercise On Physical And Mental Health In Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06518525
- Acronym / sponsor ID
- B.30.2.AYD.0.00.00
- Conditions
- Primary Dysmenorrhea
- Keywords
- Primary Dysmenorrhea, Menstruation, Pain, Tele-Exercise, pilates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Derya AzimUniversity, hospital or other
- Collaborators
- Okan University
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 24 Jul 2024 (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.
In this study, the investigators will aim to investigate the effects of Pilates-based tele-exercise on the physical and mental health of women with primary dysmenorrhea. The study will include 22 volunteers diagnosed with primary dysmenorrhea. Participants will be randomly divided into two groups. The first group will undergo Pilates-based tele-exercises (6 weeks/2 days/50 minutes) (PTTE, n=11). The second group will be a non-intervention control group (CG, n=11). Pain severity will be assessed using the Visual Analog Scale (VAS), and menstrual information will be evaluated using the Menstrual Symptom Questionnaire (MSQ), Menstrual Attitude Questionnaire (MAQ), and Functional and Emotional Dysmenorrhea Scale (FEDS). Quality of life will be assessed using the Nottingham Health Profile (NHP).
Detailed description
In this study, the investigators will aim to investigate the effects of Pilates-based tele-exercise on the physical and mental health of women with primary dysmenorrhea. The study will include 22 volunteers diagnosed with primary dysmenorrhea. Participants will be randomly divided into two groups. The first group will undergo Pilates-based tele-exercises (6 weeks/2 days/50 minutes) (PTTE, n=11). The second group will be a non-intervention control group (CG, n=11). Pain severity will be assessed using the Visual Analog Scale (VAS), and menstrual information will be evaluated using the Menstrual Symptom Questionnaire (MSQ), Menstrual Attitude Questionnaire (MAQ), and Functional and Emotional Dysmenorrhea Scale (FEDS). Quality of life will be assessed using the Nottingham Health Profile (NHP).Inclusion criteria were determined as follows: being between 18-30 years old, diagnosed with primary dysmenorrhea during an ultrasound examination, having a PD pain score of 4-7 cm on the Visual Analog Scale (VAS), being able to attend Pilates sessions twice a week, not engaging in regular exercise, and having a regular menstrual cycle (30-35 days) and bleeding duration (3-10 days). Exclusion criteria included being pregnant, having serious comorbidities (neurological, cardiovascular, and musculoskeletal disorders), and not willing to participate in the study. Volunteers who agree to participate in the study will sign an informed consent form, after which they will be given the necessary information about the scales used in the assessment. The scales will be filled out by the participants based on their previous menstrual experiences. After the assessment, Pilates-based tele-rehabilitation exercises will be applied for 6 weeks. At the end of the 6 weeks, assessments will be repeated in both groups. The scales applied to both groups before and after the study will be uploaded to the Google Forms database and sent to the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pilates-based tele-exercises | Experimental | Other: pilates-based tele-exercisesParticipants in the primary dysmenorrhea study group will be given a general introduction to Pilates-based tele-exercises, and they will be taught five essential elements that they should continuously practice during the exercise process. These elements will be control, breathing, fluidity, precision, and centering. They will be instructed on how to activate the core muscles, including the transverse abdominis, pelvic floor, and multifidus muscles, through isometric contractions while exhaling (centering). The exercises will be conducted over 6 weeks, twice a week, with each session lasting 50 minutes. The exercises, predetermined by the researcher, will be performed under the supervision of a physiotherapist. Each session will be structured into warm-up exercises, main exercises, and cool-down exercises. . |
| control group | No intervention | –control group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being between 18-30 years old,
- Diagnosed with primary dysmenorrhea during an ultrasound examination,
- Having a PD pain score of 4-7 cm on the Visual Analog Scale (VAS),
- Being able to attend Pilates sessions twice a week,
- Not engaging in regular exercise,
Key exclusion criteria (3 listed)
- Being pregnant,
- Having serious comorbidities (neurological, cardiovascular, and musculoskeletal disorders),
- Not willing to participate in 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 |
|---|---|---|
| pilates-based tele-exercisespilates-based tele-exercises | Other | pilates-based tele-exercises |
Primary outcome
Sure, here is the English translation: Visual Analog Scale
Time frame: Baseline and 6 weeks later
The Visual Analog Scale (VAS) was used to assess pain in the study. The VAS is a horizontal or vertical line that is 10 cm in length. At the beginning of the line, the phrase "no pain" is placed, and at the end, "unbearable pain" is written. Participants are asked to mark the point on the line that corresponds to the severity of the pain they experience. The distance between the point where the VAS value is the lowest and the point where the patient marked is measured, and the numerical value corresponding to the pain severity is recorded
Nottingham Health Profile
Time frame: Baseline and 6 weeks later
The Nottingham Health Profile (NHP) is a quality of life assessment questionnaire developed in 1987 to determine the degree to which individuals' perceived health problems affect their daily activities. The Turkish version of the scale was developed and psychometrically evaluated by Küçükdeveci et al. The NHP consists of six sub-dimensions: pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), physical activity (8 items), and energy (3 items). The questionnaire is answered with 'yes' or 'no'. Each section of the questionnaire is calculated separately; the sub-dimension score is obtained by summing the 'yes' responses to the items in each sub-dimension and dividing by the number of items in that sub-dimension, then multiplying by 100. Each sub-dimension scores between 0 and 100, with higher scores indicating lower quality of life
Menstrual Symptom Questionnaire
Time frame: Baseline and 6 weeks later
he Menstrual Symptom Questionnaire (MSQ) was developed in English by Chesney and Tasto in 1975 to assess pain and other symptoms associated with menstruation. The Turkish validity and reliability were completed by Güvenç et al. in 2014. The scale consists of 24 items in total, in a 5-point Likert-type format. It includes three sub-dimensions: 'Negative Effects/Somatic Complaints' (13 items), 'Pain Symptoms' (6 items), and 'Coping Methods' (3 items). Participants are asked to rate the symptoms they experience during menstruation as 1 (never), 2 (rarely), 3 (sometimes), 4 (often), and 5 (always). The score for each sub-dimension is calculated as the average of the total points of the items in that sub-dimension. The total score of the MSQ is calculated by averaging the total points of all scale items; higher scores indicate greater severity of menstrual symptoms.
Menstrual Attitude Questionnaire
Time frame: Baseline and 6 weeks later
The Menstrual Attitude Questionnaire (MAQ) was developed by Brooks-Gunn and Ruble in 1980, and its validity and reliability in Turkey were established by Kulakaç et al. in 2008. The Turkish version of the MAQ consists of 33 items and five sub-scales in a Likert-type format. These sub-scales are 'Menstruation as a debilitating event' (12 items), 'Menstruation as a bothersome event' (6 items), 'Menstruation as a natural event' (5 items), 'Anticipation and prediction of menstruation' (5 items), and 'Denial of menstruation effects' (7 items). Participants are asked to select one of the following options for each question: 1. Strongly disagree, 2. Disagree, 3. Neutral, 4. Agree, and 5. Strongly agree. Higher average scores from the items, sub-dimensions, or the entire scale indicate a more positive attitude towards menstruation.
Functional and Emotional Dysmenorrhea Scale
Time frame: Baseline and 6 weeks later
The Functional and Emotional Dysmenorrhea Scale (FEDS) is used to measure functional and emotional health in dysmenorrhea. It was developed by Li et al. in 2012, and its Turkish validity and reliability were established by Gün in 2014. The FEDS consists of 14 items in total, with two sub-dimensions: functional dysmenorrhea and emotional dysmenorrhea. Participants are asked to choose the option that best describes their condition for each item: 1. Does not resemble my condition at all, 2. Does not quite resemble my condition, 3. Both resembles and does not resemble my condition, 4. Somewhat resembles my condition, 5. Very much resembles my condition. Higher scores indicate greater functional and emotional impact from dysmenorrhea.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available for use by other researchers.
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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. This study is not recruiting at the moment.
Emine Atıcı principal investigator
Okan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pilates-based tele-exercises in people with Primary Dysmenorrhea, run by Derya Azim 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 26 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sure, here is the English translation: Visual Analog Scale (time frame: Baseline and 6 weeks later). The study lists 5 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 26 Feb 2025.