An interventional study of PLISSIT Model-Based Counseling in Female Sexual Dysfunction, sponsored by Al-Zaytoonah University of Jordan. Completed at 1 site in Jordan. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Al-Zaytoonah University of Jordan · Not applicable, Interventional, and Prevention
Hormonal contraceptives are widely used by women to prevent pregnancy. However, some women experience sexual problems, such as reduced sexual desire, difficulty becoming sexually aroused, inadequate lubrication, difficulty reaching orgasm, or pain during sexual activity. These problems may negatively affect women's psychological well-being and quality of life.
This randomized controlled trial aimed to evaluate whether counseling based on the PLISSIT model could improve sexual function and reduce psychological distress among women experiencing sexual dysfunction while using hormonal contraceptives.
A total of 374 eligible women were randomly assigned to two groups. The intervention group received structured counseling based on the PLISSIT model, which includes four levels: Permission, Limited Information, Specific Suggestions, and Intensive Therapy. The counseling was delivered through five interactive group sessions. The control group received routine care without the structured PLISSIT counseling intervention.
Sexual function was assessed using the Female Sexual Function Index (FSFI), while psychological distress was assessed using the Kessler Psychological Distress Scale (K10). Both outcomes were measured before the intervention and four weeks after the intervention.
The study sought to determine whether PLISSIT-based counseling could improve women's sexual function and reduce psychological distress compared with routine care. The findings may help inform the development of nursing counseling interventions that address women's sexual health and psychological well-being.
This study was a parallel-group randomized controlled trial conducted among women attending two maternal and child health centers in Shibin El Kom, Menoufia Governorate, Egypt, between June and November 2025.
The study included 374 women who were using hormonal contraceptive methods and reported sexual dysfunction at baseline. Eligible participants were randomly allocated in a 1:1 ratio to either an intervention group or a control group.
The intervention group received structured counseling based on the PLISSIT model, a framework for addressing sexual health concerns through four progressive levels:
The intervention was delivered through five interactive group counseling sessions, each lasting approximately one hour. The control group received routine maternal and child health services without the structured PLISSIT counseling program.
The primary outcome was sexual function, assessed using the Female Sexual Function Index (FSFI). The secondary outcome was psychological distress, assessed using the Kessler Psychological Distress Scale (K10).
Both outcomes were assessed at baseline and four weeks after the intervention. The study compared changes in sexual function and psychological distress between the intervention and control groups to evaluate the effectiveness of PLISSIT-based counseling.
The study was designed to assess whether structured, nurse-led psychosexual counseling could provide an effective approach to improving sexual health and psychological well-being among women using hormonal contraceptives.
Al-Zaytoonah University of Jordan is the lead sponsor of 31 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received routine maternal and child health care services
Participants and care providers were not blinded to group allocation because of the nature of the counseling intervention. Outcome assessors and the statistical analyst were blinded to participants' group assignments.
Behavioral: PLISSIT Model-Based Counseling
A structured behavioral counseling intervention based on the PLISSIT model (Permission, Limited Information, Specific Suggestions, and Intensive Therapy). The intervention consisted of five interactive group counseling sessions, each lasting approximately one hour. Sessions addressed sexual health concerns among women using hormonal contraceptives, provided information about sexual function, and offered specific recommendations to manage reported sexual difficulties. The intervention aimed to improve sexual function and reduce psychological distress.
Change in Female Sexual Function Index (FSFI) Total Score
Sexual function was assessed using the Female Sexual Function Index (FSFI), a 19-item questionnaire covering six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score was used to evaluate changes in sexual function following PLISSIT model-based counseling. Higher total scores indicate better sexual function.
Time frame: Baseline (before the intervention) and 4 weeks after the intervention.
Plan to share: Yes
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Nov 2025, 5 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Al-Zaytoonah University of Jordan