HealthyPregnant WomenNCT06530108
The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes Towards Sexuality and Sexual Distress in Pregnant Women
A study testing PLISSIT model based sexual health education in people with Healthy and Pregnancy Related, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes towards Sexuality and Sexual Distress in Pregnant Women Purpose of the study: In the light of these data, the effect of sexual health education based on the PLISSIT model on sexual function, attitude towards sexuality and sexual… Read more about this study
- Who is it for?
- Ages 19 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pregnancy Related, Stress
- What is being tested?
- PLISSIT model based sexual health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2024to 1 Aug 2025
- 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 19 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
inclusion criteria: Volunteer to participate, 19 years of age and over, sexually active, at least primary school graduate, of Turkish origin, no communication problems, 14th-20th age, fluent in Turkish. Pregnant women in their 2nd week will be included in the study.
exclusion criteria: Pregnant women who are at serious risk during pregnancy, who are diagnosed with sexual dysfunction, who have mental problems that require treatment, and who use drugs that cause sexual dysfunction will not be included in the study Pregnant women who leave their information forms unfinished, experience loss, and want to leave the study will be excluded.
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Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa
Istanbul, 34320
About this study
The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes towards Sexuality and Sexual Distress in Pregnant Women
Purpose of the study: In the light of these data, the effect of sexual health education based on the PLISSIT model on sexual function, attitude towards sexuality and sexual distress in nulliparous pregnant women will be examined in a randomized controlled experimental study. It is thought that the data to be obtained will shed light on sexual health education and counseling practices for midwives working with pregnant women in their application areas.
Read the detailed description
The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes towards Sexuality and Sexual Distress in Pregnant Women
Method of the study: FSFI will be applied to pregnant women between 14-20 weeks of gestation who apply to Trakya University Health Research and Application Center Obstetrics Clinic, Polyclinic and Perinatology Clinic departments, and women with a score ≤ 26.55 as a result of the FSFI evaluation will be defined as having sexual dysfunction. Pregnant women will be randomized according to the last digit of their protocol number. Pregnant women divided into control and intervention groups will be given PLISSIT model-based sexual health education to the intervention group and a clinical procedure will be applied to the control group. The Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered simultaneously. Four weeks after the training, the FSFI application and the Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered again.
- Conditions
- Healthy, Pregnancy Related, Stress
- Being tested
- PLISSIT model based sexual health education
- Keywords
- sexual function, sexual attitude, sexual distress, midwife care, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLISSIT model based sexual health educationBehavioural
the PLISSIT model includes the steps of PLISSIT (P-Permission), LI-Limited Information, SS-Specific Suggestions, IT-Intensive Therapy. This model provides communication with the patient and Since it is a model that increases confidence and provides care interventions based on the patient's preference, it has the feature of guiding sexual education during pregnancy by establishing the bond between the pregnant woman and the midwife.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention Group | Experimental | PLISSIT model-based sexual health education will be provided to the intervention group, and the clinical procedure will be applied to the control group. The Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered simultaneously. Four weeks after the training, the FSFI application and the Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered again Receives: Behavioral: PLISSIT model based sexual health education |
| Kontrol Group | Placebo comparator | The clinical procedure will be applied to the control group Receives: Behavioral: PLISSIT model based sexual health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Function Level
Women with a score ≤ 26.55 as a result of the FSFI evaluation will be defined as having sexual dysfunction.
Measured: 12 Mounth
Secondary outcomes (2)
Attitude Towards Sexuality During Pregnancy
An increase in the Attitude Towards Sexuality During Pregnancy score indicates that attitudes towards sexuality during pregnancy are positive.
Measured: 12 mounth
Sexual Distres Level
KCDÖ-R consists of 13 items that evaluate different aspects of sexual distress in women and varies between 0-52 points. The scale is a five-point Likert type and is scored between 0-4 points (always=4, often=3, sometimes=2, rarely=1, never=0), and 11.5 and above is defined as sexual distress.
Measured: 12 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start18 May 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research will be conducted using randomized controlled, experimental type and single-blindresearch methods. For this purpose, after the data are collected, they will be coded as A and Bgroups, so the researcher who will make the research statistics will analyze the data withoutknowing the study and control groups. Randomization method will be used to determine thegroups. For this, the patients who meet the study criteria and volunteer will be assigned to thegroups using the randomization program 'Random Allocation Software 2.0' according to the orderof hospitalization.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Demirezen, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530108
- Sponsor's protocol ID
- E-74555795-199-990466 17.05.24
- Other IDs
- 17.05.2024-990466
- Acronym
- Pregnant Women
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes Towards Sexuality and Sexual Distress in Pregnant Women
- ClinicalTrials.gov ID
- NCT06530108
- Acronym / sponsor ID
- Pregnant Women / E-74555795-199-990466 17.05.24
- Conditions
- Healthy, Pregnancy Related, Stress
- Keywords
- sexual function, sexual attitude, sexual distress, midwife care, education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 18 May 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 31 Jul 2024 (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 Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes towards Sexuality and Sexual Distress in Pregnant Women
Purpose of the study: In the light of these data, the effect of sexual health education based on the PLISSIT model on sexual function, attitude towards sexuality and sexual distress in nulliparous pregnant women will be examined in a randomized controlled experimental study. It is thought that the data to be obtained will shed light on sexual health education and counseling practices for midwives working with pregnant women in their application areas.
Detailed description
The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes towards Sexuality and Sexual Distress in Pregnant Women
Method of the study: FSFI will be applied to pregnant women between 14-20 weeks of gestation who apply to Trakya University Health Research and Application Center Obstetrics Clinic, Polyclinic and Perinatology Clinic departments, and women with a score ≤ 26.55 as a result of the FSFI evaluation will be defined as having sexual dysfunction. Pregnant women will be randomized according to the last digit of their protocol number. Pregnant women divided into control and intervention groups will be given PLISSIT model-based sexual health education to the intervention group and a clinical procedure will be applied to the control group. The Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered simultaneously. Four weeks after the training, the FSFI application and the Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered again.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research will be conducted using randomized controlled, experimental type and single-blindresearch methods. For this purpose, after the data are collected, they will be coded as A and Bgroups, so the researcher who will make the research statistics will analyze the data withoutknowing the study and control groups. Randomization method will be used to determine thegroups. For this, the patients who meet the study criteria and volunteer will be assigned to thegroups using the randomization program 'Random Allocation Software 2.0' according to the orderof hospitalization.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group | Experimental | Behavioral: PLISSIT model based sexual health educationPLISSIT model-based sexual health education will be provided to the intervention group, and the clinical procedure will be applied to the control group. The Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered simultaneously. Four weeks after the training, the FSFI application and the Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered again |
| Kontrol Group | Placebo comparator | Behavioral: PLISSIT model based sexual health educationThe clinical procedure will be applied to the control group |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| PLISSIT model based sexual health educationthe PLISSIT model includes the steps of PLISSIT (P-Permission), LI-Limited Information, SS-Specific Suggestions, IT-Intensive Therapy. This model provides communication with the patient and Since it is a model that increases confidence and provides care interventions based on the patient's preference, it has the feature of guiding sexual education during pregnancy by establishing the bond between the pregnant woman and the midwife. | Behavioural | Experimental: Intervention Group, Kontrol Group |
Primary outcome
Sexual Function Level
Time frame: 12 Mounth
Women with a score ≤ 26.55 as a result of the FSFI evaluation will be defined as having sexual dysfunction.
2 secondary outcomes
Attitude Towards Sexuality During Pregnancy
Time frame: 12 mounth
Sexual Distres Level
Time frame: 12 mounth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLISSIT model based sexual health education in people with Healthy and Pregnancy Related, run by Istanbul University - Cerrahpasa 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?
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 31 Jul 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Function Level (time frame: 12 Mounth). 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 31 Jul 2024.