NCT04764838

Brief Summary

This study was planned as a single blind randomized controlled type in order to examine the effect of yoga on sexual function in primipara pregnant women.150 pregnant women will be randomized.The data will be interviewed online with pregnant women and online yoga training will be held for the intervention group

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

February 18, 2021

Last Update Submit

February 18, 2021

Conditions

Keywords

pregnancySexual functionyoga

Outcome Measures

Primary Outcomes (1)

  • sexual function

    FSFI(FEMALE SEXUAL FUNCTION INDEX)

    4 weeks

Secondary Outcomes (1)

  • Body ımage

    4 weeks

Study Arms (2)

Intervantion

EXPERIMENTAL

Pregnant Yoga

Other: Yoga

Control

NO INTERVENTION

The clinic will receive routine care

Interventions

YogaOTHER

Breath Awareness Training (5 minutes) Asanas (20 minutes) * Bending sideways in Mountain Stance * Standing Pelvic Shaking Warrior Stance II Squatting and malasana (wreath pose) Breath awareness in lotus pose (sitting) Cane pose Fixed Butterfly / Angel Pose * Sitting wide in Angel Pose Cat Pose Tiger Breath Mudra and meditation (10 minutes)

Intervantion

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-35,
  • In primiparous pregnant women (18-26 weeks),
  • Female Sexual Function Scale (FSFI) score\> 22.7,
  • Volunteering to participate in research,
  • To speak Turkish.

You may not qualify if:

  • Having a disability that makes it difficult for the pregnant woman to do yoga asanas,
  • have done yoga Subtraction criterion Not attending the trainings regularly,
  • Not attending at least 5 of the trainings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Hospital

Sultangazı, Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalMotor Activity

Interventions

Yoga

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Fatma Şule Tanrıverdi, MsC

    Haseki Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Şule Tanrıverdi, MsC

CONTACT

Aysu Karaahmet, MsC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Will not be shared with other researchers and statisticians related to the intervention and control group.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Randomized controlled single blind
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 21, 2021

Study Start

January 10, 2021

Primary Completion

June 10, 2021

Study Completion

October 10, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

This study was planned as a single blind randomized controlled type in order to examine the effect of yoga on sexual function in primipara pregnant women.150 women were randomized. Pregnant women in the intervention group are applied online yoga, and pregnant women in the control group receive clinical routine care.

Shared Documents
STUDY PROTOCOL
Time Frame
January-June ( 6 monts)

Locations