NCT06300112

Brief Summary

The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

March 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 2, 2024

Last Update Submit

March 10, 2024

Conditions

Keywords

MidwiferyPerceived StressSexual Quality of LifeSleepPregnancy

Outcome Measures

Primary Outcomes (2)

  • Perceived stress level

    This will be measured using "Perceived Stress Scale". The minimum score that can be obtained from the scale is "0", the maximum score is "32", and as the scale score increases, perceived stress level also increase.

    6 weeks

  • Sexual Quality of Life

    This will be measured using "Sexual Quality of Life Questionnaire-Female". The minimum score that can be obtained from the scale is "18", the maximum score is "108". The total score obtained from the scale must be converted to 100. As the scale score increases, perceived stress level also increase.

    6 weeks

Other Outcomes (1)

  • Sleep patterns

    6 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Yoga

Behavioral: YOGA

Control group

NO INTERVENTION

No Intervention

Interventions

YOGABEHAVIORAL

Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks.

Experimental group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnancy week between 24 and 34,
  • Able to read and write Turkish,
  • No communication problems,
  • Those who voluntarily agreed to participate in the research

You may not qualify if:

  • Those who have risky pregnancies,
  • Those with diagnosed psychiatric problems,
  • Participating in a different training program (meditation, relaxation, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University

Amasya, 05100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexuality

Interventions

Yoga

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Emine İbici Akça

    Amasya University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine İbici Akça, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized-controlled trial with pretest-posttest control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr. in the Amasya University Midwifery Department

Study Record Dates

First Submitted

March 2, 2024

First Posted

March 8, 2024

Study Start

March 15, 2024

Primary Completion

May 31, 2024

Study Completion

June 30, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations