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

NCT04821232 | Unknown

• 1 other identifier: pmsyoga
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Keywords

Premenstrual Sendrom; yoga; midwifery student

Outcome Measures

Primary Outcomes (3)

• Standardized cross-sectional rating scales

  premenstrual syndrome scale

  Change from Baseline PMS scale at 2 months

• Standardized cross-sectional rating scales

  Beck Depression Inventory

  Change from Baseline Beck Depression Inventory scale at 2 months

• Standardized cross-sectional rating scales

  VISUAL ANALOG SCALE(VAS)

  Change from VAS Inventory scale at 2 months

Secondary Outcomes (4)

• effect on blood parameters

  Change from CRP parameters at 2 months

• effect on blood parameters

  Change from sedimentation parameters at 2 months

• effect on blood parameters

  Change from progesterone parameters at 2 months

• effect on blood parameters

  Change from estrogen parameters at 2 months

Study Arms (2)

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.

Other: yoga; Other: Routin control

Control groups

OTHER

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

Other: Routin control

Interventions

yoga 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.

interventional

Routin control OTHER

Students will be checked on a routine basis

Control groups; interventional

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Premestrual sendrom
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Haseki Training and Research Hospital

Sultanbeyli, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Yoga

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Aysu Yıldız Karaahmet, Phd.Student

  Halic University

  PRINCIPAL INVESTIGATOR

• Fatma Sule Tanrıverdi, PhD student

  Halic University

  PRINCIPAL INVESTIGATOR

• Murat Ekmez, Dr

  Health Sciences University-Haseki Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Aysu Yıldız Karaahmet, PhD Student

CONTACT

05414679620; aysuyildiz@halic.edu.tr

Fatma Sule Tanrıverdi, Phd.Student

CONTACT

05413606482; sulebilgic@halic.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research data had blinded the statistician.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single blind randomized controlled trial

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: March 29, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: until data is collected

Locations

TU (1)