- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05348954
Determining the Effects of Sexual Health Education and Counseling Given to Women in the Postpartum Period Based on the EX-PLISSIT Model on Sexual Life
February 8, 2024 updated by: Nergiz Eryilmaz, Karamanoğlu Mehmetbey University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nergiz Eryilmaz, Master
- Phone Number: +905458848830
- Email: nergizeryilmaz@kmu.edu.tr
Study Contact Backup
- Name: Ayten Şentürk Erenel, Prof
Study Locations
-
-
Merkez
-
Karaman, Merkez, Turkey
- Recruiting
- Karaman Halk Sağlığı Müdürlüğü
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sexual dysfunction of women
|
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.
|
|
Experimental: Quality of sexual life
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EX-PLISSIT Model
Time Frame: EX-PLISSIT Model will be conducted to participants one weeks later after the first session
|
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
|
|
THE FEMALE SEXUAL DISTRESS SCALE-REVISED
Time Frame: They will get an sexual health education and then their sexual disstress will be measured 4 weeks later
|
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
|
|
SEXUAL QUALITY OF LIFE SCALE-FEMALE
Time Frame: They will get an sexual health education and then their sexual quality of life will be measured 4 weeks later
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2023
Primary Completion (Actual)
October 30, 2023
Study Completion (Estimated)
June 2, 2024
Study Registration Dates
First Submitted
February 14, 2022
First Submitted That Met QC Criteria
April 21, 2022
First Posted (Actual)
April 27, 2022
Study Record Updates
Last Update Posted (Actual)
February 12, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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