NCT04695808

Brief Summary

Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the adoption of yoga practice without health risks by women and its implementation as a lifestyle may be effective in reducing the symptoms of menopause experienced by women. In line with this information, it is aimed to determine the effect of yoga training on menopausal symptoms. The research will be carried out with menopausal women between the ages of 40-60 in Famagusta region. Women will be divided into two groups as intervention and control. Personal information form and menopause rating scale will be used in the research. The intervention group will be given yoga practice two days a week for 10 weeks. Menopause rating scale will be applied to the intervention and control group before and after the research.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

1 month

First QC Date

December 28, 2020

Last Update Submit

May 26, 2022

Conditions

Menopause

Keywords

menopauseyogasymptoms

Outcome Measures

Primary Outcomes (1)

  • menopause rating scale

    It was developed in German by Schneider et al. In 1992 to measure the severity of menopausal symptoms and was adapted to English in 1996. MRT was adapted to Turkish by Gürkan in our country in 2005. There are "0 = None", "1 = Mild", "2 = Moderate", "3 = Severe" and "4 = Very severe" options for each item in the Likert-type scale consisting of 11 items including menopausal complaints. The total score of the scale is calculated based on the scores given for each item. The lowest score that can be obtained from the scale is 0, the highest score is 44.

    3 months

Study Arms (2)

intervention group

EXPERIMENTAL

Yoga practice will be done two days a week for 10 weeks.

Behavioral: yoga

control group

NO INTERVENTION

no intervention

Interventions

yogaBEHAVIORAL

Yoga practice will be done two days a week for 10 weeks.

intervention group

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen aged 40-60 who are in menopause
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willing to participate in research,
  • Can read and write in Turkish,
  • Open to communication,
  • Those who are between the ages of 40-60 and do not experience menstruation for at least one year, Do not use medication to treat menopausal symptoms,
  • No diagnosed musculoskeletal disease, no severe heart disease,
  • Not doing regular exercise and yoga,
  • Not surgically menopausal,
  • Women without psychiatric problems

You may not qualify if:

  • Refusing to participate in research,
  • Can't read and write Turkish,
  • Communication is not possible,
  • Those who are younger than 40 or older than 60 have experienced menstruation for at least one year
  • Using medication for the treatment of menopausal symptoms,
  • Those with a diagnosed musculoskeletal disease, severe heart disease,
  • Doing regular exercise and yoga,
  • Surgically menopausal, Women with psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 90, Cyprus

Location

Related Links

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior İnstructor

Study Record Dates

First Submitted

December 28, 2020

First Posted

January 5, 2021

Study Start

September 15, 2020

Primary Completion

October 15, 2020

Study Completion

November 29, 2020

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

CY(1)