NCT05348954

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

May 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

February 14, 2022

Last Update Submit

February 8, 2024

Conditions

SexualityNurse's RolePostpartum Disorder

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Sexual dysfunction of women

EXPERIMENTAL

Sexual dysfunction of women

Other: EX-PLISSIT MODEL

Quality of sexual life

EXPERIMENTAL

Quality of sexual life

Other: EX-PLISSIT MODEL

Interventions

EX-PLISSIT MODELOTHER

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.

Quality of sexual lifeSexual dysfunction of women

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe 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.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Halk Sağlığı Müdürlüğü

Karaman, Merkez, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

SexualityPuerperal Disorders

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Nergiz Eryilmaz, Master

CONTACT

+905458848830nergizeryilmaz@kmu.edu.tr

Ayten Şentürk Erenel, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2022

First Posted

April 27, 2022

Study Start

May 5, 2023

Primary Completion

October 30, 2023

Study Completion

June 2, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)