PLISSIT ModelNCT05260697
The Effect of Sexual Counseling Based on PLISSIT Model to Women Undergoing Open Heart Surgery on Sexual Function and Sexual Quality of Life
A study testing sexual counselling with plissit model in people with PLISSIT Model and Sexual Counselling, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study is about sexual counseling after cardiac surgery; It can contribute to the counseling planning of nurses and other health professionals regarding sexual problems that may occur after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PLISSIT Model, Sexual Counselling
- What is being tested?
- sexual counselling with plissit model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Nov 2020to 1 Apr 2022
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the research
- Being a woman
- Being over 18 years old
- Willingness to undergo open heart surgery
- Euroscore score ≤ 6 (low mortality risk due to cardiac surgery)
- Being sexually active
Show all 10Show fewer
- Absence of sexual health problems in the spouse
- Ability to communicate verbally and be literate
- Women without neurological or psychiatric disorders
- Knowing Turkish
Who cannot join
- Unwillingness to participate in the research
- Euroscore score >6 (high risk of mortality)
- Not being sexually active
- Having a diagnosed sexual health problem in the spouse
- Women with neurological and psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Merve TUNCER
Istanbul
Merve TUNCER, 0537 504 8017, mervecaglar90@hotmail.com
About this study
This study is about sexual counseling after cardiac surgery; It can contribute to the counseling planning of nurses and other health professionals regarding sexual problems that may occur after surgery. Increasing the quality of life in the rehabilitation process after cardiac surgery and facilitating adaptation to life after surgery; but not enough.
- Conditions
- PLISSIT Model, Sexual Counselling
- Being tested
- sexual counselling with plissit model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sexual counselling with plissit modelOther
sexual counselling
| Study group | Role | What they receive |
|---|---|---|
| Sexual Counselling Group | Experimental | Sexual Counselling with PLISSIT model Receives: Other: sexual counselling with plissit model |
| Control Group | No intervention | no intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
'Female Sexual Function Index' scores will increase after sexual counseling based on the PLISSIT model will be given to individuals who will undergo open heart surgery.
Measured: 1 year
After the sexual counseling based on the PLISSIT model to be given to the individuals who will undergo open heart surgery, the scores of the "Sexual Quality of Life Scale-Female Form" will increase.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start16 Nov 2020
- Primary completion30 Dec 2021
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PLISSIT ModelStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Tuncer, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260697
- Sponsor's protocol ID
- 13022260-302.14.05
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tuncer M, Yesiltepe Oskay U. Effect of sexual counseling on sexual function and sexual quality of life for women undergoing open heart surgery: a pilot randomized controlled trial. J Sex Med. 2023 Jun 28;20(7):1010-1017. doi: 10.1093/jsxmed/qdad065.
PubMed 37246308
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Counseling Based on PLISSIT Model to Women Undergoing Open Heart Surgery on Sexual Function and Sexual Quality of Life
- ClinicalTrials.gov ID
- NCT05260697
- Acronym / sponsor ID
- 13022260-302.14.05
- Conditions
- PLISSIT Model, Sexual Counselling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 2 Mar 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.
This study is about sexual counseling after cardiac surgery; It can contribute to the counseling planning of nurses and other health professionals regarding sexual problems that may occur after surgery. Increasing the quality of life in the rehabilitation process after cardiac surgery and facilitating adaptation to life after surgery; but not enough.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sexual Counselling Group | Experimental | Other: sexual counselling with plissit modelSexual Counselling with PLISSIT model |
| Control Group | No intervention | –no intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Volunteering to participate in the research
- Being a woman
- Being over 18 years old
- Willingness to undergo open heart surgery
- Euroscore score ≤ 6 (low mortality risk due to cardiac surgery)
Key exclusion criteria (5 listed)
- Unwillingness to participate in the research
- Euroscore score >6 (high risk of mortality)
- Not being sexually active
- Having a diagnosed sexual health problem in the spouse
- Women with neurological and psychiatric disorders
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 |
|---|---|---|
| sexual counselling with plissit modelsexual counselling | Other | Sexual Counselling Group |
Primary outcome
'Female Sexual Function Index' scores will increase after sexual counseling based on the PLISSIT model will be given to individuals who will undergo open heart surgery.
Time frame: 1 year
After the sexual counseling based on the PLISSIT model to be given to the individuals who will undergo open heart surgery, the scores of the "Sexual Quality of Life Scale-Female Form" will increase.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 37246308Tuncer M, Yesiltepe Oskay U. Effect of sexual counseling on sexual function and sexual quality of life for women undergoing open heart surgery: a pilot randomized controlled trial. J Sex Med. 2023 Jun 28;20(7):1010-1017. doi: 10.1093/jsxmed/qdad065.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sexual counselling with plissit model in people with PLISSIT Model and Sexual Counselling, 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?
The sponsor lists 10 inclusion and 5 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 2 Mar 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
'Female Sexual Function Index' scores will increase after sexual counseling based on the PLISSIT model will be given to individuals who will undergo open heart surgery. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260697, which also lists 1 linked publication.
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 2 Mar 2022.