The Effect of Yoga on Sexual Function in Primiparous Pregnants

The Effect of Yoga on Sexual Function in Primiparous Pregnants: Single-Blind Randomized Controlled Study

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

Study Overview

• Status: Recruiting
• Conditions: Sexual Dysfunction; Pregnancy Related; Exercise
• Intervention / Treatment: Other: Yoga

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatma Şule Tanrıverdi, Msc; Phone Number: 5413606482; Email: sulebilgic@halic.edu.tr
• Study Contact Backup: Name: Aysu Karaahmet, MsC; Phone Number: 541 467 96 20; Email: aysuyildiz@halic.edu.tr

Study Locations

• Turkey
  • Istanbul
    • Sultangazı, Istanbul, Turkey
      • Recruiting
      • Haseki Hospital
      • Contact: Fatma Şule Tanrıverdi, PhD Student; Phone Number: 5413606482; Email: sulebilgic@halic.edu.tr
      • Contact: Aysu Yıldız Karaahmet, PhD Student; Phone Number: 5414679620; Email: aysuyildiz@halic.edu.tr
      • Principal Investigator: Aysu Yıldız Karaahmet, phd student
      • Sub-Investigator: Hüsniye Dinç Kaya, Asist. Prof.
      • Sub-Investigator: Tülay Yılmaz, Asist. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervantion; Pregnant Yoga	Other: Yoga; 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)
No Intervention: Control; The clinic will receive routine care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Halic University
• Collaborators: Istanbul University - Cerrahpasa (IUC)
• Investigators: Principal Investigator: Fatma Şule Tanrıverdi, MsC, Haseki Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2021
• Primary Completion (Anticipated): June 10, 2021
• Study Completion (Anticipated): October 10, 2021

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: pregnancy; yoga; Sexual function
• Other Study ID Numbers: Yoga on Sexual Function

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan 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.
• IPD Sharing Time Frame: January-June ( 6 monts)
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No