Clinical trial NCT04821232: Does Yoga Done To Women With Premenstrual Syndrome Affect Inflammation Parameters?
Official title: Does Yoga Done To Women With Premenstrual Syndrome Affect Inflammation Parameters?: Single Blind, Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: Premenstrual Sendrom
yoga
midwifery student
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blind randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Standardized cross-sectional rating scales
timeFrame: Change from Baseline PMS scale at 2 months
measure: Standardized cross-sectional rating scales
timeFrame: Change from Baseline Beck Depression Inventory scale at 2 months
measure: Standardized cross-sectional rating scales
timeFrame: Change from VAS Inventory scale at 2 months
Secondary outcomes:
measure: effect on blood parameters
timeFrame: Change from CRP parameters at 2 months
measure: effect on blood parameters
timeFrame: Change from sedimentation parameters at 2 months
measure: effect on blood parameters
timeFrame: Change from progesterone parameters at 2 months
measure: effect on blood parameters
timeFrame: Change from estrogen parameters at 2 months
Other outcomes:
Locations:
city: Sultanbeyli
country: Turkey
facility: Haseki Training and Research Hospital
state: İstanbul
Study officials:
affiliation: Halic University
name: Aysu Yıldız Karaahmet, Phd.Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Halic University
name: Fatma Sule Tanrıverdi, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Sciences University-Haseki Training and Research Hospital
name: Murat Ekmez, Dr
role: STUDY_DIRECTOR
References: