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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

Primary Purpose

Sexuality, Nurse's Role, Postpartum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EX-PLISSIT MODEL
Sponsored by
Karamanoğlu Mehmetbey University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexuality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Sexual dysfunction of women

    Quality of sexual life

    Arm Description

    Sexual dysfunction of women

    Quality of sexual life

    Outcomes

    Primary Outcome Measures

    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.
    THE FEMALE SEXUAL DISTRESS SCALE-REVISED
    Measuring sex-related personal distress for women
    SEXUAL QUALITY OF LIFE SCALE-FEMALE
    This scale measures the quality of sex life.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2022
    Last Updated
    April 21, 2022
    Sponsor
    Karamanoğlu Mehmetbey University
    Collaborators
    Gazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05348954
    Brief Title
    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
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2, 2022 (Anticipated)
    Primary Completion Date
    September 2, 2022 (Anticipated)
    Study Completion Date
    June 2, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karamanoğlu Mehmetbey University
    Collaborators
    Gazi University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sexuality, Nurse's Role, Postpartum Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled experimental study
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sexual dysfunction of women
    Arm Type
    Experimental
    Arm Description
    Sexual dysfunction of women
    Arm Title
    Quality of sexual life
    Arm Type
    Experimental
    Arm Description
    Quality of sexual life
    Intervention Type
    Other
    Intervention Name(s)
    EX-PLISSIT MODEL
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    EX-PLISSIT Model
    Description
    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.
    Time Frame
    EX-PLISSIT Model will be conducted to participants one weeks later after the first session
    Title
    THE FEMALE SEXUAL DISTRESS SCALE-REVISED
    Description
    Measuring sex-related personal distress for women
    Time Frame
    They will get an sexual health education and then their sexual disstress will be measured 4 weeks later
    Title
    SEXUAL QUALITY OF LIFE SCALE-FEMALE
    Description
    This scale measures the quality of sex life.
    Time Frame
    They will get an sexual health education and then their sexual quality of life will be measured 4 weeks later

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    The population of the study will be composed of women who are registered to family health centers determined by randomization in Karaman city center and who are in the 10 weeks-6 months postpartum period.
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nergiz Eryilmaz, Master
    Phone
    +905458848830
    Email
    nergizeryilmaz@kmu.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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