SexualityNCT05348954
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
A study testing EX-PLISSIT MODEL in people with Sexuality and Nurse's Role, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexuality, Nurse's Role, Postpartum Disorder
- What is being tested?
- EX-PLISSIT MODEL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2023to 2 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Having a spouse/partner
- Having a smartphone or computer with a camera
- Being at least literate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ayten Şentürk Erenel, Prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karaman Halk Sağlığı Müdürlüğü
Karaman, Merkez
About this study
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.
- Conditions
- Sexuality, Nurse's Role, Postpartum Disorder
- Being tested
- EX-PLISSIT MODEL
- Medical subject headings
- Sexuality, Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Sexual dysfunction of women | Experimental | Sexual dysfunction of women Receives: Other: EX-PLISSIT MODEL |
| Quality of sexual life | Experimental | Quality of sexual life Receives: Other: EX-PLISSIT MODEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: They will get an sexual health education and then their sexual quality of life will be measured 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start5 May 2023
- Primary completion30 Oct 2023
- Study completion2 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SexualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Nergiz Eryilmaz, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348954
- Sponsor's protocol ID
- study1
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05348954
- Acronym / sponsor ID
- study1
- Conditions
- Sexuality, Nurse's Role, Postpartum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 5 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 2 Jun 2024 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Sexual dysfunction of women | Experimental | Other: EX-PLISSIT MODELSexual dysfunction of women |
| Quality of sexual life | Experimental | Other: EX-PLISSIT MODELQuality of sexual life |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EX-PLISSIT MODELThe 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. | Other | Quality of sexual life, Sexual dysfunction of women |
Primary outcome
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayten Şentürk Erenel, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EX-PLISSIT MODEL in people with Sexuality and Nurse's Role, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nergiz Eryilmaz, Master (+905458848830, nergizeryilmaz@kmu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EX-PLISSIT Model (time frame: EX-PLISSIT Model will be conducted to participants one weeks later after the first session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.