Premenstrual SyndromeNCT05998044
Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial
A study testing Pilates Based Exercises in people with Premenstrual Syndrome and Stress, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of Pilates Based Exercises on premenstrual symptom (PMS) symptoms, perceived stress level and pain intensity. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Stress
- What is being tested?
- Pilates Based Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 12 Oct 2023
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a woman between the ages of 18-35.
- Not having a condition that prevents exercise (not having orthopedic, cardiopulmonary, mental diseases, etc. that will prevent exercise).
- Not having given birth.
- Volunteer to participate in the study.
- Having a score above the mild level on the PMSS score.
- Normal menstrual cycle.
Who cannot join
- Having a condition that prevents you from exercising.
- Having a chronic disease.
- Being on any medication regularly.
- Being pregnant.
- Being in the menopausal period.
- Having a gynecological disease (endometriosis, ovarian cyst, pelvic infection, fibroid/uterine tumor etc.)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the effects of Pilates Based Exercises on premenstrual symptom (PMS) symptoms, perceived stress level and pain intensity.
Read the detailed description
The research is a quantitative study, and it is in the form of randomized controlled type research, one of the experimental research types. The sample of the study consisted of people who scored above the mild level according to the Premenstrual Syndrome Scale (PMSS) score and volunteered to participate in the study. Participants will be divided into 2 groups as experimental group and control group by randomization method. Sociodemographic Information Form, Premenstrual Syndrome Scale (PMSS), Perceived Stress Scale (PSS) and Mcgill Melzack Pain Scale (MPQ) will be administered to the participants. Pre- and post-intervention data were statistically analyzed and compared.
- Conditions
- Premenstrual Syndrome, Stress
- Being tested
- Pilates Based Exercises, control
- Keywords
- stress, Pilates Based Exercises
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates Based ExercisesOther
The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). The first four exercises were used for the warm-up period and the last four exercises were used for the stretching period. The exercises will be done as 1 set of 8 repetitions. The Hundred exercise will be increased to 10 sets of 10 reps every two weeks to 10 reps, 12 reps, and 14 reps, respectively. Participants will be asked to open the video recording each time they exercise and follow them to do the exercises.
Exercise Program:
- Arm Circles
- Toe Touch
- bridge
- Shoulder Bridge
- Chest Lift
- Hundred
- Roll Up
- Leg Circles
- Chris Cross
- Side Kick
- Side Leg Circles
- one leg kick
- double leg kick
- Swan
- Single leg Stretch
- Double leg Stretch
- saw
- Spine Stretch
controlOther
They will be asked not to participate in any regular exercise for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Before starting the study for the Control Group, the participants were informed about the research and their consent will be obtained. Afterwards, evaluation surveys will be applied. They will be asked not to participate in any regular exercise for 8 weeks. At the end of 8 weeks, re-evaluation surveys will be applied. Receives: Other: control |
| pilates group | Experimental | After people fill out the evaluation questionnaires, they will watch the video recording of pilates based exercises via the link sent to them via Google Drive, and they will be applied twice a week for 8 weeks. All exercises in the video recording will be explained in written, applied and verbal form by the physiotherapist, and they will be asked to practice. Every week, feedback will be received from people that they have done the exercises via their contact numbers. The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). Participants will be asked to open the video recording each time they exercise and follow them to do the exercises. At the end of 8 weeks, re-evaluation surveys will be applied. Receives: Other: Pilates Based Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Scale (PMSS)
PMSS is a 44-item five-point Likert-type scale (Never, Rarely, Sometimes, Often, and Continuous). As stated in the instruction at the beginning of the scale, after the item is read, marking is made by taking into account the scale on the right of the relevant item, according to the "being in the period one week before the period". In scoring the scale, "Never" option is evaluated as 1 point, "Very little" option as 2 points, "Sometimes" option as 3 points, "Often" option as 4 points and "Constantly" option as 5 points. the high score is 220. In addition, PMSS severity classes can be created according to the scores obtained from the scale. Accordingly, a score of 88 and above from the PMSS scale total indicates severe PMS symptoms, and a score below 88 indicates mild premenstrual syndrome symptoms.
Measured: 10 weeks
Perceived Stress Scale (PSS)
The perceived stress scale consists of 14 five-point Likert type items. The scale consists of "never (0), almost never" (1), "sometimes" (2), "often" (3) "very often" (4). In this 14-item form, items 4-5-6-7-9-10 and 13 are scored in reverse. The lowest and highest scores that the participant can obtain from this scale are 0 and 56, respectively. A high total score means a high Perceived Stress Level Scale. It can be said that the participants, whose score range is between 0-35, are in a positive stress level, can effectively cope with stress, and the coping mechanisms they use are also functional. It can be said that the methods used by the participants with a score range of 36-56 to cope with stress are not functional, and therefore they cannot cope with stress effectively.
Measured: 10 weeks
McGill Melzack Pain Questionnaire (MPQ)
MPQ consists of four parts. In the first part, the patient is asked to mark the location of the pain on the body chart and to indicate with the letter 'D' if the pain is deep and 'Y' on the body surface. In the second part, the patient is asked what he compares his pain to. There are 20 word groups with 2 to 6 descriptive words that describe pain in terms of sensory, perceptual and evaluation. The first 10 groups of words include the sensory dimension, the next 5 the perceptual dimension, the 16th group evaluation, and the last 4 groups of multifaceted words that indicate different aspects of pain. In the third part, the relationship of pain with time is asked. In addition, it is asked what reduces pain and what increases it. In the fourth chapter; The patient is asked questions to determine the severity of pain. Evaluation is made on a rating scale consisting of words describing the severity of pain.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Aug 2023
- Primary completion12 Oct 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies 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
- Pilates exercises will be given to the experimental group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Şeyma AYKUT, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998044
- Sponsor's protocol ID
- Uskudar66
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52.
PubMed 12725453Citil ET, Kaya N. Effect of pilates exercises on premenstrual syndrome symptoms: a quasi-experimental study. Complement Ther Med. 2021 Mar;57:102623. doi: 10.1016/j.ctim.2020.102623. Epub 2020 Nov 24.
PubMed 33246104El-Lithy A, El-Mazny A, Sabbour A, El-Deeb A. Effect of aerobic exercise on premenstrual symptoms, haematological and hormonal parameters in young women. J Obstet Gynaecol. 2015 May;35(4):389-92. doi: 10.3109/01443615.2014.960823. Epub 2014 Oct 3.
PubMed 25279689Di Lorenzo CE. Pilates: what is it? Should it be used in rehabilitation? Sports Health. 2011 Jul;3(4):352-61. doi: 10.1177/1941738111410285.
PubMed 23016028Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.
PubMed 22030232
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05998044
- Acronym / sponsor ID
- Uskudar66
- Conditions
- Premenstrual Syndrome, Stress
- Keywords
- stress, Pilates Based Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 18 Aug 2023 (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.
The aim of this study is to examine the effects of Pilates Based Exercises on premenstrual symptom (PMS) symptoms, perceived stress level and pain intensity.
Detailed description
The research is a quantitative study, and it is in the form of randomized controlled type research, one of the experimental research types. The sample of the study consisted of people who scored above the mild level according to the Premenstrual Syndrome Scale (PMSS) score and volunteered to participate in the study. Participants will be divided into 2 groups as experimental group and control group by randomization method. Sociodemographic Information Form, Premenstrual Syndrome Scale (PMSS), Perceived Stress Scale (PSS) and Mcgill Melzack Pain Scale (MPQ) will be administered to the participants. Pre- and post-intervention data were statistically analyzed and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilates exercises will be given to the experimental group
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: controlBefore starting the study for the Control Group, the participants were informed about the research and their consent will be obtained. Afterwards, evaluation surveys will be applied. They will be asked not to participate in any regular exercise for 8 weeks. At the end of 8 weeks, re-evaluation surveys will be applied. |
| pilates group | Experimental | Other: Pilates Based ExercisesAfter people fill out the evaluation questionnaires, they will watch the video recording of pilates based exercises via the link sent to them via Google Drive, and they will be applied twice a week for 8 weeks. All exercises in the video recording will be explained in written, applied and verbal form by the physiotherapist, and they will be asked to practice. Every week, feedback will be received from people that they have done the exercises via their contact numbers. The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). Participants will be asked to open the video recording each time they exercise and follow them to do the exercises. At the end of 8 weeks, re-evaluation surveys will be applied. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being a woman between the ages of 18-35.
- Not having a condition that prevents exercise (not having orthopedic, cardiopulmonary, mental diseases, etc. that will prevent exercise).
- Not having given birth.
- Volunteer to participate in the study.
- Having a score above the mild level on the PMSS score.
Key exclusion criteria (6 listed)
- Having a condition that prevents you from exercising.
- Having a chronic disease.
- Being on any medication regularly.
- Being pregnant.
- Being in the menopausal period.
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 ExercisesThe average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). The first four exercises were used for the warm-up period and the last four exercises were used for the stretching period. The exercises will be done as 1 set of 8 repetitions. The Hundred exercise will be increased to 10 sets of 10 reps every two weeks to 10 reps, 12 reps, and 14 reps, respectively. Participants will be asked to open the video recording each time they exercise and follow them to do the exercises. Exercise Program: * Arm Circles * Toe Touch * bridge * Shoulder Bridge * Chest Lift * Hundred * Roll Up * Leg Circles * Chris Cross * Side Kick * Side Leg Circles * one leg kick * double leg kick * Swan * Single leg Stretch * Double leg Stretch * saw * Spine Stretch | Other | pilates group |
| controlThey will be asked not to participate in any regular exercise for 8 weeks. | Other | control group |
Primary outcome
Premenstrual Syndrome Scale (PMSS)
Time frame: 10 weeks
PMSS is a 44-item five-point Likert-type scale (Never, Rarely, Sometimes, Often, and Continuous). As stated in the instruction at the beginning of the scale, after the item is read, marking is made by taking into account the scale on the right of the relevant item, according to the "being in the period one week before the period". In scoring the scale, "Never" option is evaluated as 1 point, "Very little" option as 2 points, "Sometimes" option as 3 points, "Often" option as 4 points and "Constantly" option as 5 points. the high score is 220. In addition, PMSS severity classes can be created according to the scores obtained from the scale. Accordingly, a score of 88 and above from the PMSS scale total indicates severe PMS symptoms, and a score below 88 indicates mild premenstrual syndrome symptoms.
Perceived Stress Scale (PSS)
Time frame: 10 weeks
The perceived stress scale consists of 14 five-point Likert type items. The scale consists of "never (0), almost never" (1), "sometimes" (2), "often" (3) "very often" (4). In this 14-item form, items 4-5-6-7-9-10 and 13 are scored in reverse. The lowest and highest scores that the participant can obtain from this scale are 0 and 56, respectively. A high total score means a high Perceived Stress Level Scale. It can be said that the participants, whose score range is between 0-35, are in a positive stress level, can effectively cope with stress, and the coping mechanisms they use are also functional. It can be said that the methods used by the participants with a score range of 36-56 to cope with stress are not functional, and therefore they cannot cope with stress effectively.
McGill Melzack Pain Questionnaire (MPQ)
Time frame: 10 weeks
MPQ consists of four parts. In the first part, the patient is asked to mark the location of the pain on the body chart and to indicate with the letter 'D' if the pain is deep and 'Y' on the body surface. In the second part, the patient is asked what he compares his pain to. There are 20 word groups with 2 to 6 descriptive words that describe pain in terms of sensory, perceptual and evaluation. The first 10 groups of words include the sensory dimension, the next 5 the perceptual dimension, the 16th group evaluation, and the last 4 groups of multifaceted words that indicate different aspects of pain. In the third part, the relationship of pain with time is asked. In addition, it is asked what reduces pain and what increases it. In the fourth chapter; The patient is asked questions to determine the severity of pain. Evaluation is made on a rating scale consisting of words describing the severity of pain.
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 13 Oct 2023.
- Background: PubMed 12725453Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52.
- Background: PubMed 33246104Citil ET, Kaya N. Effect of pilates exercises on premenstrual syndrome symptoms: a quasi-experimental study. Complement Ther Med. 2021 Mar;57:102623. doi: 10.1016/j.ctim.2020.102623. Epub 2020 Nov 24.
- Background: PubMed 25279689El-Lithy A, El-Mazny A, Sabbour A, El-Deeb A. Effect of aerobic exercise on premenstrual symptoms, haematological and hormonal parameters in young women. J Obstet Gynaecol. 2015 May;35(4):389-92. doi: 10.3109/01443615.2014.960823. Epub 2014 Oct 3.
- Background: PubMed 23016028Di Lorenzo CE. Pilates: what is it? Should it be used in rehabilitation? Sports Health. 2011 Jul;3(4):352-61. doi: 10.1177/1941738111410285.
- Background: PubMed 22030232Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.
- Individual participant dataSharing planned: No
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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.
Şeyma AYKUT study chair
Uskudar 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 Exercises in people with Premenstrual Syndrome and Stress, run by Uskudar 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 6 inclusion and 6 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 13 Oct 2023. 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?
Premenstrual Syndrome Scale (PMSS) (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05998044, which also lists 5 linked publications.
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 13 Oct 2023.