The Effect of Yoga on Sexual Function in Primiparous Preg... | NCT04764838

Studies
The Effect of Yoga on Sexual Function in Primiparous Pregnants

NCT04764838

Sponsor

Halic University

Status

Unknown status

Last Update Posted

Feb 21, 2021Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Pregnancy Related
Sexual Dysfunction
Exercise

Interventions

Yoga

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2021Actual

Primary Completion Date

Jun 10, 2021Estimated

Completion Date

Oct 10, 2021Estimated

First Submitted Date

Feb 18, 2021

First Submission Date that Met QC Criteria

Feb 18, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2021

Last Update Posted Date

Feb 21, 2021Actual

Name	Class
Istanbul University - Cerrahpasa	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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. The data of the research will be collected through the "Data Collection Form, Female Sexual Function Scale (FSFI)" and The Body Exposure During Sexual Activities Questionnaire (BESAQ), which are created by the researchers by scanning the literature. Research Volunteers who apply to SBU Haseki Training and Research Hospital Pregnancy Outpatient Clinic and meet the sample selection criteria will constitute the sample of the study. In order to determine the minimum sample size required for this study, the power analysis 80% power and α = 0.50 were calculated to include a total of 138 women with a minimum 69 sample size in each group. The intervention and control ratio is 1. However, considering the probability of loss, 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, and the data will be uploaded to the ISM SPSS 22.0 (Statistical Package for the Social Sciences) statistics program; Parametric (Anova and T test) and nonparametric (Mann-Whitney U Test, Kruskal Wallis, Chi Square) statistical methods will be used.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervantion	Experimental	Pregnant Yoga	Other: Yoga
Control	No Intervention	The clinic will receive routine care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Yoga	Other	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sexual function	FSFI(FEMALE SEXUAL FUNCTION INDEX)	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Body ımage	BESAQ (The Body Exposure during Sexual Activities Questionnaire)	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fatma Şule Tanrıverdi, MsC	Contact	5413606482		sulebilgic@halic.edu.tr
Aysu Karaahmet, MsC	Contact	541 467 96 20		aysuyildiz@halic.edu.tr

Overall Officials

Name	Affiliation	Role
Fatma Şule Tanrıverdi, MsC	Haseki Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haseki Hospital	Recruiting	Sultangazı	Istanbul		Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol

Time Frame

January-June ( 6 monts)

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012735	Sexual Dysfunction, Physiological
D009043	Motor Activity

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015013	Yoga

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

Masking Description

Will not be shared with other researchers and statisticians related to the intervention and control group.

Who Masked

InvestigatorOutcomes Assessor