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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05348954
Other study ID # study1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 5, 2023
Est. completion date June 2, 2024

Study information

Verified date February 2024
Source Karamanoglu Mehmetbey University
Contact Nergiz Eryilmaz, Master
Phone +905458848830
Email nergizeryilmaz@kmu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study will be to determine the effect of the sexual health education and counseling program, which is given to women in the postpartum period based on the Ex-PLISSIT model, on women's sexual life, including sexual function, sexual distress and sexual life quality.


Description:

The study is a multicenter, parallel randomized controlled experimental study with block randomization.For the determination of the working groups, the researcher; will give general information about the research to women who have applied to the family health center and meet the inclusion criteria in the postpartum period of 10 weeks-6 months and agree to participate, and will receive their written and verbal consent for participation.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date June 2, 2024
Est. primary completion date October 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Being primiparous - Having given birth at 38-42 weeks of gestation, - Having a single birth, - Not experiencing any postpartum complications - The time elapsed from birth is between 10 weeks and 6 months - Being sexually active - Having a spouse/partner - Having a smartphone or computer with a camera - Being at least literate Exclusion Criteria: - A previous sexual function of the woman herself or her husband. - Having a chronic disease that she expresses herself (such as cardiovascular disease, hypertension, etc.) - Having a health problem that requires the baby to be hospitalized - Having received sexual education/counselling - Spouse or self-diagnosed mental problem - Having a diagnosis that will affect sexual function or body image, such as mastectomy

Study Design


Intervention

Other:
EX-PLISSIT MODEL
The content of the program will include information about the anatomy and physiology of the male-female reproductive system, sexuality and sexual cycle physiology, factors affecting sexuality, postpartum changes, hormonal changes, breastfeeding and their effects on sexuality, and methods of contraception.

Locations

Country Name City State
Turkey Karaman Halk Sagligi Müdürlügü Karaman Merkez

Sponsors (2)

Lead Sponsor Collaborator
Karamanoglu Mehmetbey University Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary EX-PLISSIT Model The content of the program will include information about the anatomy and physiology of the male-female reproductive system, sexuality and sexual cycle physiology, factors affecting sexuality, postpartum changes, hormonal changes, breastfeeding and their effects on sexuality, and methods of contraception. EX-PLISSIT Model will be conducted to participants one weeks later after the first session
Primary THE FEMALE SEXUAL DISTRESS SCALE-REVISED Measuring sex-related personal distress for women They will get an sexual health education and then their sexual disstress will be measured 4 weeks later
Primary SEXUAL QUALITY OF LIFE SCALE-FEMALE This scale measures the quality of sex life. They will get an sexual health education and then their sexual quality of life will be measured 4 weeks later
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