Female Sexual DysfunctionHormonalNCT07916441
PLISSIT Model Counseling on Sexual Function and Psychological Distress Among Hormonal Contraceptive Users
A study testing PLISSIT Model-Based Counseling in people with Female Sexual Dysfunction, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- PLISSIT Model-Based Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteJordan
- Study dates
- 4 Jun 2025to 7 Dec 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women using hormonal contraceptive methods.
- Women reporting sexual dysfunction at baseline, defined by an FSFI total score below 28.
- Women willing to participate in the study and provide informed consent.
Who cannot join
- Women who were not using hormonal contraceptive methods.
- Women without sexual dysfunction at baseline.
- Women with chronic physical or mental health conditions that could interfere with sexual function or participation in the counseling intervention.
- Women who participated in the pilot study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of PLISSIT Model Counseling on Sexual Function and Psychological Distress Among Hormonal Contraceptive Users in Egypt: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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:
- Permission: Encouraging women to express their sexual concerns in a supportive and confidential environment.
- Limited Information: Providing relevant information about sexual health, hormonal contraception, and factors that may affect sexual function.
- Specific Suggestions: Offering individualized recommendations and practical strategies to address reported sexual difficulties.
- Intensive Therapy: Identifying women who may require further specialized assessment or referral.
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.
- Conditions
- Female Sexual Dysfunction
- Being tested
- PLISSIT Model-Based Counseling
- Keywords
- PLISSIT Counseling Sexual Function Sexual Dysfunction Hormonal Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLISSIT Model-Based CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Participants received routine maternal and child health care services |
| PLISSIT Model Counseling | Experimental | 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. Receives: Behavioral: PLISSIT Model-Based Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before the intervention) and 4 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start4 Jun 2025
- Primary completion5 Nov 2025
- Study completion7 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm, parallel-group randomized controlled trial comparing PLISSIT model-based counseling with routine care among women using hormonal contraceptives who reported sexual dysfunction.
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Abdelfatah Shokr, Al-Zaytoonah University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916441
- Sponsor's protocol ID
- #990; Aug 16, 2023
- Acronym
- Hormonal
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of PLISSIT Model Counseling on Sexual Function and Psychological Distress Among Hormonal Contraceptive Users in Egypt: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07916441
- Acronym / sponsor ID
- Hormonal / #990; Aug 16, 2023
- Conditions
- Female Sexual Dysfunction
- Keywords
- PLISSIT Counseling Sexual Function Sexual Dysfunction Hormonal Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 7 Dec 2025 (actual)
- First posted
- 4 Nov 2026 (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.
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.
Detailed description
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:
- Permission: Encouraging women to express their sexual concerns in a supportive and confidential environment.
- Limited Information: Providing relevant information about sexual health, hormonal contraception, and factors that may affect sexual function.
- Specific Suggestions: Offering individualized recommendations and practical strategies to address reported sexual difficulties.
- Intensive Therapy: Identifying women who may require further specialized assessment or referral.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-arm, parallel-group randomized controlled trial comparing PLISSIT model-based counseling with routine care among women using hormonal contraceptives who reported sexual dysfunction.
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | –Participants received routine maternal and child health care services |
| PLISSIT Model Counseling | Experimental | Behavioral: PLISSIT Model-Based CounselingParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women using hormonal contraceptive methods.
- Women reporting sexual dysfunction at baseline, defined by an FSFI total score below 28.
- Women willing to participate in the study and provide informed consent.
Key exclusion criteria (4 listed)
- Women who were not using hormonal contraceptive methods.
- Women without sexual dysfunction at baseline.
- Women with chronic physical or mental health conditions that could interfere with sexual function or participation in the counseling intervention.
- Women who participated in the pilot study.
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 CounselingA 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. | Behavioural | PLISSIT Model Counseling |
Primary outcome
Change in Female Sexual Function Index (FSFI) Total Score
Time frame: Baseline (before the intervention) and 4 weeks after the intervention.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes
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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 Counseling in people with Female Sexual Dysfunction, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 4 Nov 2026. 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Female Sexual Function Index (FSFI) Total Score (time frame: Baseline (before the intervention) and 4 weeks after the intervention.). 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 4 Nov 2026.