Premenstrual SyndromeNCT04821232
Does Yoga Done To Women With Premenstrual Syndrome Affect Inflammation Parameters?
A study testing yoga in people with Premenstrual Syndrome, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
The menstrual cycle is one of the most important signs of a functioning reproductive system in women, but sometimes this cycle is associated with signs and symptoms that cause physical and psychological problems for women. 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
- What is being tested?
- yoga
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Sep 2021
- 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 in the age range of 18-35
- To be of reproductive age,
- Not giving birth before, Healthy women with regular menstrual periods (those who have bleeding between menstrual cycles for 3-8 days for 21-35 days),
- To be an undergraduate student,
- AcOG PMS criteria (according to ACOG diagnostic criteria; women with at least one premenstrual syndrome and symptoms in at least three consecutive cycles)
Who cannot join
- Having a regular yoga history for 3 months before and during the workout;
- Having a chronic disease (Endocrine, DM, Heart diseases, psychiatric illness) Oral contraceptive use
- To have a physical problem that prevents him from doing yoga asanas
- Over cyst and PICOS
- Get a score lower than 110 from the total scale score according to the PMS scale score
- Over 10 in Beck Depression Inventory, Students with a history of gynecological surgery were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Sultanbeyli, Istanbul
Murat Ekmez, Dr., 05552114135
About this study
Official title: Does Yoga Done To Women With Premenstrual Syndrome Affect Inflammation Parameters?: Single Blind, Randomized Controlled Trials
The menstrual cycle is one of the most important signs of a functioning reproductive system in women, but sometimes this cycle is associated with signs and symptoms that cause physical and psychological problems for women.
Considering the high prevalence of PMS among women and the complications of this syndrome on work performance, social and interpersonal relationships and family, and its role in limiting education, social and economic progress in society, 8 weeks of online yoga exercises given online to female students were helpful in reducing PMS symptoms The aim was to evaluate the efficacy and effect on inflammation parameters. The study was planned as an interventional, single-blind, randomized controlled study. The sample size of this study was calculated based on the latest research available on the effect of exercise on PMS (Kamalifard et al.2017). A power analysis was performed in student PMS scores between exercise and control groups and to expect a difference of 80% strength and α = 0.50 and 30%. 80% power (1 - ß) minimum 18 students for each group, total 36 students will be included in the sample.
Read the detailed description
The menstrual cycle is one of the most important signs of a functioning reproductive system in women, but sometimes this cycle is associated with signs and symptoms that cause physical and psychological problems for women.
Considering the high prevalence of PMS among women and the complications of this syndrome on work performance, social and interpersonal relationships and family, and its role in limiting education, social and economic progress in society, 8 weeks of online yoga exercises given online to female students were helpful in reducing PMS symptoms The aim was to evaluate the efficacy and effect on inflammation parameters. The study was planned as an interventional, single-blind, randomized controlled study. The sample size of this study was calculated based on the latest research available on the effect of exercise on PMS (Kamalifard et al.2017). A power analysis was performed in student PMS scores between exercise and control groups and to expect a difference of 80% strength and α = 0.50 and 30%. 80% power (1 - ß) minimum 18 students for each group, total 36 students will be included in the sample.
The researcher will provide brief information about the scope of the research by interviewing the students who meet the case selection criteria online. Verbal and written consents of the "Informed Consent Form" will be obtained (written consents will be sent to the researcher online). Female students who accepted to participate in the study were given the "Data Collection Form" (see Annex: 1), "Beck Depression Inventory" (APPENDIX: 2), Visual Pain Scale (VAS) (see APPENDIX: 3) and PMS for 3 cycles. Scale (see Annex: 4) will be applied using the online data collection method. Students who meet the sample selection criteria will be randomly allocated to the intervention and control group by the method of computer-assisted randomization (www.randomizer.org). In order to ensure blindness, randomization and random distribution of the participants to the groups will be done by a researcher and will not be shared with other researchers. and Body Mass Index will be calculated. CRP, Procalcitonin, sedimentation, Interleukin (IL) -2, IL-4, IL-6, IL-10, IL-12, and interferon from all participants on the day of the highest VAS score (the day when symptoms peak) and the day when symptoms were highest. (IFN gamma), TNF alpha and PMS scale will be taken. Students in the intervention group will be given a total of 120 minutes out of 40 minutes, and 24 sessions of yoga for 8 weeks, 3 days a week. The researcher who will make yoga with each student will be sent videos on the online platform, including a yoga presentation and a full yoga session with the students after a yoga session. The students were asked to do yoga 3 times a week in accordance with the video and the researcher will be called twice a week to get information about the process.
- Conditions
- Premenstrual Syndrome
- Being tested
- yoga, Routin control
- Keywords
- Premenstrual Sendrom, yoga, midwifery student
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaOther
Content of education;
- Breath Awareness Training (10 minutes) Students will be checked on a routine basis
- Asanas (20 minutes) I. Don't bend sideways in Mountain Pose ii. Warrior Pose iii. Bridge Pose iv. Happy Baby Pose
- Fixed Butterfly / Angel Pose vi. Wide sitting in Angel Pose vii. Cat Pose Tiger Breath viii. Cow-downward dog, ix. Plank x. Cobra c. Mudra and meditation (10 minutes) will be practiced.
Routin controlOther
Students will be checked on a routine basis
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | Students in the intervention group will be given a total of 120 minutes out of 40 minutes, and 24 sessions of yoga for 8 weeks, 3 days a week. The researcher who will make yoga with each student will be sent videos on the online platform, including a yoga introduction and a full yoga session with the students after a yoga session. The students were asked to do yoga 3 times a week in accordance with the video and the researcher will be called twice a week to get information about the process. Content of education;
1. Breath Awareness Training (10 minutes)
2. Asanas (20 minutes) I. Don't bend sideways in Mountain Pose ii. Warrior Pose iii. Bridge Pose iv. Happy Baby Pose
v. Fixed Butterfly / Angel Pose vi. Wide sitting in Angel Pose vii. Cat Pose Tiger Breath viii. Cow-downward dog, ix. Plank x. Cobra c. Mudra and meditation (10 minutes) will be practiced. Receives: Other: yoga; Other: Routin control |
| Control groups | Other | No intervention will be applied to students in the control group. Receives: Other: Routin control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized cross-sectional rating scales
premenstrual syndrome scale
Measured: Change from Baseline PMS scale at 2 months
Standardized cross-sectional rating scales
Beck Depression Inventory
Measured: Change from Baseline Beck Depression Inventory scale at 2 months
Standardized cross-sectional rating scales
VISUAL ANALOG SCALE(VAS)
Measured: Change from VAS Inventory scale at 2 months
Secondary outcomes (4)
effect on blood parameters
CRP,from all participants on the day the highest score on VAS was obtained (the day when symptoms peak) and the day when symptoms were highest
Measured: Change from CRP parameters at 2 months
effect on blood parameters
sedimentation,from all participants on the day the highest score on VAS was obtained (the day when symptoms peak) and the day when symptoms were highest
Measured: Change from sedimentation parameters at 2 months
effect on blood parameters
progesterone from all participants on the day the highest score on VAS was obtained (the day when symptoms peak) and the day when symptoms were highest
Measured: Change from progesterone parameters at 2 months
effect on blood parameters
estrogen from all participants on the day the highest score on VAS was obtained (the day when symptoms peak) and the day when symptoms were highest
Measured: Change from estrogen parameters at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysu Yıldız Karaahmet, Halic University
- Investigators
- Aysu Yıldız Karaahmet, Phd.Student, Principal investigator, Halic UniversityFatma Sule Tanrıverdi, PhD student, Principal investigator, Halic UniversityMurat Ekmez, Dr, Study director, Health Sciences University-Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821232
- Sponsor's protocol ID
- pmsyoga
- Status last verified
- Mar 2021
- First submitted
- 11 Feb 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Yoga Done To Women With Premenstrual Syndrome Affect Inflammation Parameters?: Single Blind, Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT04821232
- Acronym / sponsor ID
- pmsyoga
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Sendrom, yoga, midwifery student
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 29 Mar 2021 (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 menstrual cycle is one of the most important signs of a functioning reproductive system in women, but sometimes this cycle is associated with signs and symptoms that cause physical and psychological problems for women.
Considering the high prevalence of PMS among women and the complications of this syndrome on work performance, social and interpersonal relationships and family, and its role in limiting education, social and economic progress in society, 8 weeks of online yoga exercises given online to female students were helpful in reducing PMS symptoms The aim was to evaluate the efficacy and effect on inflammation parameters. The study was planned as an interventional, single-blind, randomized controlled study. The sample size of this study was calculated based on the latest research available on the effect of exercise on PMS (Kamalifard et al.2017). A power analysis was performed in student PMS scores between exercise and control groups and to expect a difference of 80% strength and α = 0.50 and 30%. 80% power (1 - ß) minimum 18 students for each group, total 36 students will be included in the sample.
Detailed description
The menstrual cycle is one of the most important signs of a functioning reproductive system in women, but sometimes this cycle is associated with signs and symptoms that cause physical and psychological problems for women.
Considering the high prevalence of PMS among women and the complications of this syndrome on work performance, social and interpersonal relationships and family, and its role in limiting education, social and economic progress in society, 8 weeks of online yoga exercises given online to female students were helpful in reducing PMS symptoms The aim was to evaluate the efficacy and effect on inflammation parameters. The study was planned as an interventional, single-blind, randomized controlled study. The sample size of this study was calculated based on the latest research available on the effect of exercise on PMS (Kamalifard et al.2017). A power analysis was performed in student PMS scores between exercise and control groups and to expect a difference of 80% strength and α = 0.50 and 30%. 80% power (1 - ß) minimum 18 students for each group, total 36 students will be included in the sample.
The researcher will provide brief information about the scope of the research by interviewing the students who meet the case selection criteria online. Verbal and written consents of the "Informed Consent Form" will be obtained (written consents will be sent to the researcher online). Female students who accepted to participate in the study were given the "Data Collection Form" (see Annex: 1), "Beck Depression Inventory" (APPENDIX: 2), Visual Pain Scale (VAS) (see APPENDIX: 3) and PMS for 3 cycles. Scale (see Annex: 4) will be applied using the online data collection method. Students who meet the sample selection criteria will be randomly allocated to the intervention and control group by the method of computer-assisted randomization (www.randomizer.org). In order to ensure blindness, randomization and random distribution of the participants to the groups will be done by a researcher and will not be shared with other researchers. and Body Mass Index will be calculated. CRP, Procalcitonin, sedimentation, Interleukin (IL) -2, IL-4, IL-6, IL-10, IL-12, and interferon from all participants on the day of the highest VAS score (the day when symptoms peak) and the day when symptoms were highest. (IFN gamma), TNF alpha and PMS scale will be taken. Students in the intervention group will be given a total of 120 minutes out of 40 minutes, and 24 sessions of yoga for 8 weeks, 3 days a week. The researcher who will make yoga with each student will be sent videos on the online platform, including a yoga presentation and a full yoga session with the students after a yoga session. The students were asked to do yoga 3 times a week in accordance with the video and the researcher will be called twice a week to get information about the process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Other: yoga, Other: Routin controlStudents in the intervention group will be given a total of 120 minutes out of 40 minutes, and 24 sessions of yoga for 8 weeks, 3 days a week. The researcher who will make yoga with each student will be sent videos on the online platform, including a yoga introduction and a full yoga session with the students after a yoga session. The students were asked to do yoga 3 times a week in accordance with the video and the researcher will be called twice a week to get information about the process. Content of education; 1. Breath Awareness Training (10 minutes) 2. Asanas (20 minutes) I. Don't bend sideways in Mountain Pose ii. Warrior Pose iii. Bridge Pose iv. Happy Baby Pose v. Fixed Butterfly / Angel Pose vi. Wide sitting in Angel Pose vii. Cat Pose Tiger Breath viii. Cow-downward dog, ix. Plank x. Cobra c. Mudra and meditation (10 minutes) will be practiced. |
| Control groups | Other | Other: Routin controlNo intervention will be applied to students in the control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being in the age range of 18-35
- To be of reproductive age,
- Not giving birth before, Healthy women with regular menstrual periods (those who have bleeding between menstrual cycles for 3-8 days for 21-35 days),
- To be an undergraduate student,
- AcOG PMS criteria (according to ACOG diagnostic criteria; women with at least one premenstrual syndrome and symptoms in at least three consecutive cycles)
Key exclusion criteria (6 listed)
- Having a regular yoga history for 3 months before and during the workout;
- Having a chronic disease (Endocrine, DM, Heart diseases, psychiatric illness) Oral contraceptive use
- To have a physical problem that prevents him from doing yoga asanas
- Over cyst and PICOS
- Get a score lower than 110 from the total scale score according to the PMS scale score
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 |
|---|---|---|
| yogaContent of education; 1. Breath Awareness Training (10 minutes) Students will be checked on a routine basis 2. Asanas (20 minutes) I. Don't bend sideways in Mountain Pose ii. Warrior Pose iii. Bridge Pose iv. Happy Baby Pose v. Fixed Butterfly / Angel Pose vi. Wide sitting in Angel Pose vii. Cat Pose Tiger Breath viii. Cow-downward dog, ix. Plank x. Cobra c. Mudra and meditation (10 minutes) will be practiced. | Other | interventional |
| Routin controlStudents will be checked on a routine basis | Other | Control groups, interventional |
Primary outcome
Standardized cross-sectional rating scales
Time frame: Change from Baseline PMS scale at 2 months
premenstrual syndrome scale
Standardized cross-sectional rating scales
Time frame: Change from Baseline Beck Depression Inventory scale at 2 months
Beck Depression Inventory
Standardized cross-sectional rating scales
Time frame: Change from VAS Inventory scale at 2 months
VISUAL ANALOG SCALE(VAS)
4 secondary outcomes
effect on blood parameters
Time frame: Change from CRP parameters at 2 months
effect on blood parameters
Time frame: Change from sedimentation parameters at 2 months
effect on blood parameters
Time frame: Change from progesterone parameters at 2 months
effect on blood parameters
Time frame: Change from estrogen parameters at 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: Yes
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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.
Aysu Yıldız Karaahmet, Phd.Student principal investigator
Halic University
Fatma Sule Tanrıverdi, PhD student principal investigator
Halic University
Murat Ekmez, Dr study director
Health Sciences University-Haseki Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga in people with Premenstrual Syndrome, run by Halic 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 5 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: status not confirmed, as of the sponsor's last update on 29 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysu Yıldız Karaahmet, PhD Student (05414679620, aysuyildiz@halic.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized cross-sectional rating scales (time frame: Change from Baseline PMS scale at 2 months). 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?
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 29 Mar 2021.