An interventional study of yoga and Routin control in Premenstrual Syndrome, sponsored by Halic University. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-29.
Sponsored by Halic University · Not applicable, Interventional, and Supportive care
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 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.
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This study's planned enrollment of 36 is below the median of 50 across 6,517 interventional studies indexed under Syndrome.
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Exclusion Criteria:
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.
Other: yoga · Other: Routin control
No intervention will be applied to students in the control group.
Other: Routin control
Content 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.
Students will be checked on a routine basis
Standardized cross-sectional rating scales
premenstrual syndrome scale
Time frame: Change from Baseline PMS scale at 2 months
Standardized cross-sectional rating scales
Beck Depression Inventory
Time frame: Change from Baseline Beck Depression Inventory scale at 2 months
Standardized cross-sectional rating scales
VISUAL ANALOG SCALE(VAS)
Time frame: Change from VAS Inventory scale at 2 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from estrogen parameters at 2 months
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
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Halic University