ClinicalTrials.gg
RecruitingNCT05348954Updated Feb 12, 2024

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

An interventional study of EX-PLISSIT MODEL in Sexuality, Nurse's Role and Postpartum Disorder, sponsored by Karamanoğlu Mehmetbey University. Recruiting at 1 site in Turkey. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-12.

Sponsored by Karamanoğlu Mehmetbey University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Sexuality
  • Nurse's Role
  • Postpartum Disorder
03

In context

Sexuality

130 studies on the registry are indexed under Sexuality; 26 are open to participants now.

This study's planned enrollment of 88 is above the median of 75 across 79 interventional studies indexed under Sexuality.

Browse Sexuality studies →

Lead sponsor

Karamanoğlu Mehmetbey University is the lead sponsor of 69 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    Sexual dysfunction of women

    Sexual dysfunction of women

    Other: EX-PLISSIT MODEL

  • Experimental
    Quality of sexual life

    Quality of sexual life

    Other: EX-PLISSIT MODEL

Interventions

  • OtherEX-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: EX-PLISSIT Model will be conducted to participants one weeks later after the first session

  2. THE FEMALE SEXUAL DISTRESS SCALE-REVISED

    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

  3. SEXUAL QUALITY OF LIFE SCALE-FEMALE

    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

07

Study locations

1 of 1 sites recruiting
  • Karaman Halk Sağlığı Müdürlüğü
    Karaman, Merkez, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in Oct 2023, 5 months.

Of 54 non-industry interventional studies with no phase under Sexuality, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 32. This study's 5 months is below that.

Counting every sponsor, half of 54 studies reached it within 12 months; a quarter within 6 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2022
First posted
Apr 27, 2022
StartActual
May 5, 2023
Primary completionActual
Oct 30, 2023
CompletionEst.
Jun 2, 2024
Last update
Feb 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05348954
Lead sponsor
Karamanoğlu Mehmetbey University
Collaborators
Gazi University
Responsible party
Nergiz Eryilmaz (Principal Investigator, Karamanoğlu Mehmetbey University) — Principal investigator
First posted
Apr 27, 2022
Start date
May 5, 2023
Primary completion
Oct 30, 2023
Completion
Jun 2, 2024 (estimated)
Last update
Feb 12, 2024

Study contacts

Nergiz Eryilmaz, Master
Contact
nergizeryilmaz@kmu.edu.tr
+905458848830
Ayten Şentürk Erenel, Prof
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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