Does Yoga Done To Women With Premenstrual Syndrome Affect Inflammation Parameters?

NCT ID: NCT04821232

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-09-01

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.

Conditions

Premenstrual Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

interventional

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.

Group Type: EXPERIMENTAL

yoga

Intervention Type: OTHER

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.

Routin control

Intervention Type: OTHER

Students will be checked on a routine basis

Control groups

No intervention will be applied to students in the control group.

Group Type: OTHER

Routin control

Intervention Type: OTHER

Students will be checked on a routine basis

Interventions

yoga

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.

Intervention Type: OTHER

Routin control

Students will be checked on a routine basis

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Halic University

OTHER

Sponsor Role: lead

Responsible Party

Aysu Yıldız Karaahmet

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aysu Yıldız Karaahmet, Phd.Student

Role: PRINCIPAL_INVESTIGATOR

Halic University

Fatma Sule Tanrıverdi, PhD student

Role: PRINCIPAL_INVESTIGATOR

Halic University

Murat Ekmez, Dr

Role: STUDY_DIRECTOR

Health Sciences University-Haseki Training and Research Hospital

Locations

Haseki Training and Research Hospital

Sultanbeyli, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Aysu Yıldız Karaahmet, PhD Student

Role: CONTACT

aysuyildiz@halic.edu.tr

05414679620

Fatma Sule Tanrıverdi, Phd.Student

Role: CONTACT

sulebilgic@halic.edu.tr

05413606482

Facility Contacts

Murat Ekmez, Dr.

Role: primary

05552114135

Other Identifiers

pmsyoga

Identifier Type: -

Identifier Source: org_study_id