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

Primary Purpose

Premenstrual Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
yoga
Routin control
Sponsored by
Halic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premenstrual Syndrome focused on measuring Premenstrual Sendrom, yoga, midwifery student

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Haseki Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

interventional

Control groups

Arm Description

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; Breath Awareness Training (10 minutes) 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.

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

Outcomes

Primary Outcome Measures

Standardized cross-sectional rating scales
premenstrual syndrome scale
Standardized cross-sectional rating scales
Beck Depression Inventory
Standardized cross-sectional rating scales
VISUAL ANALOG SCALE(VAS)

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
February 11, 2021
Last Updated
March 26, 2021
Sponsor
Halic University
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1. Study Identification

Unique Protocol Identification Number
NCT04821232
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Halic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Premenstrual Sendrom, yoga, midwifery student

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single blind randomized controlled trial
Masking
Outcomes Assessor
Masking Description
The research data had blinded the statistician.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interventional
Arm Type
Experimental
Arm Description
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; Breath Awareness Training (10 minutes) 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.
Arm Title
Control groups
Arm Type
Other
Arm Description
No intervention will be applied to students in the control group.
Intervention Type
Other
Intervention Name(s)
yoga
Intervention Description
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 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
Intervention Name(s)
Routin control
Intervention Description
Students will be checked on a routine basis
Primary Outcome Measure Information:
Title
Standardized cross-sectional rating scales
Description
premenstrual syndrome scale
Time Frame
Change from Baseline PMS scale at 2 months
Title
Standardized cross-sectional rating scales
Description
Beck Depression Inventory
Time Frame
Change from Baseline Beck Depression Inventory scale at 2 months
Title
Standardized cross-sectional rating scales
Description
VISUAL ANALOG SCALE(VAS)
Time Frame
Change from VAS Inventory scale at 2 months
Secondary Outcome Measure Information:
Title
effect on blood parameters
Description
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
Title
effect on blood parameters
Description
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
Title
effect on blood parameters
Description
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
Title
effect on blood parameters
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Premestrual sendrom
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aysu Yıldız Karaahmet, PhD Student
Phone
05414679620
Email
aysuyildiz@halic.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Sule Tanrıverdi, Phd.Student
Phone
05413606482
Email
sulebilgic@halic.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysu Yıldız Karaahmet, Phd.Student
Organizational Affiliation
Halic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatma Sule Tanrıverdi, PhD student
Organizational Affiliation
Halic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Murat Ekmez, Dr
Organizational Affiliation
Health Sciences University-Haseki Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haseki Training and Research Hospital
City
Sultanbeyli
State/Province
İstanbul
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murat Ekmez, Dr.
Phone
05552114135

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
until data is collected

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

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