PostmenopauseNCT05448079
The Effect of Sexual Counseling Given According to the PLISSIT Model on FSFI, MAS and SQOL-F of Postmenopausal Women
A study testing Sexual counseling according to the PLISSIT model, randomized pretest-posttest in people with Postmenopause and Sexual Function, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized pretest-posttest study to examine the effect of sexual counseling based on the PLISSIT model on post-menopausal women's sexual functions, marital adjustment and quality of sexual life. Read more about this study
- Who is it for?
- Ages 42 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause, Sexual Function, Marital Relationship
- What is being tested?
- Sexual counseling according to the PLISSIT model, randomized pretest-posttest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2020to 26 Feb 2021
- 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 42 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being in the first year of postmenopause,
- Living with spouse/partner,
- Having an active sex life,
- Being able to speak, understand and read Turkish,
- Entering menopause naturally,
- Living within the borders of Ankara province,
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- Not having menopause at an early or late age (over 40 years and under 55 years old),
- Not taking hormone replacement therapy,
- Not using herbal treatment for menopause (containing estrogen),
- Not having a type of cancer that may affect sexual function,
- Not receiving chemotherapy / radiotherapy,
- No health problems (Hypertension, Diabetes, Cardiovascular disease, Urinary incontinence),
- Not having a mental illness and/or not using drugs (antipsychotic drugs, Spironolactone, etc.),
- Not being diagnosed with COVID in the last month,
- Not having a sexual dysfunction diagnosis / treatment history in himself or his partner,
- Not getting sexual health counseling before.
Who cannot join
- Receiving sexual health counseling from another consultant during the working period,
- Desiring to leave the research at any stage of the research,
- Failure to attend at least one of the sexual health counseling sessions,
- Not participating in the post-test,
- Getting a diagnosis of COVID.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sexual Counseling Given According to the PLISSIT Model on Sexual Functions, Marital Adjustment and Quality of Sexual Life of Postmenopausal Women
This study was conducted as a randomized pretest-posttest study to examine the effect of sexual counseling based on the PLISSIT model on post-menopausal women's sexual functions, marital adjustment and quality of sexual life. Sixty women (Experimental=30, Control=30) that applied to the menopause policlinic of a Women Diseases Training and Research Hospital were included in the study. Two women dropped out later, so the study was completed with 58 (Experimental=29, Control=29) women. Firstly, women were separated into two groups according to the cut-point of (26,55) in The Female Sexual Function Index (FSFI) (those who score 26,6 and above or 26,5 and below) and then these two groups were divided into intervention and control groups randomly. Data were collected with Descriptive Questions Form, Menopause Symptom Evaluation Scale (MRS), FSFI, Marital adjustment Scale (MAS) and Sexual Quality of Life Questionnaire Scale - Female Version (SQOL-F) between September 07, 2020 and March 26, 2021. The intervention group was given sexual counselling, prepared in line with the PLISSIT model, for three weeks, once a week and lasting approximately one hour. The effect of the counseling was tested twelve weeks after counseling was completed. Women in the control group were also interviewed twice concurrent with the intervention group; once when the counseling began and once during the last assessment. Women in the control group filled some data forms. After the study was completed, the counseling was also given to women who wanted it, in the control group. Frequency and percentage values, descriptive statistics, Fisher's Exact Test, Pearson Chi Square, t tests, for non-normally distributed data Mann Whitney U test and the Wilcoxon test were used for data analysis.
Keywords: Post-menopausal period, sexual counseling, PLISSIT model, nursing care
Read the detailed description
Akbay-Kısa, A. S., The effect of sexual counseling given according to the PLISSIT model on sexual functions, marital adjustment and quality of sexual life of postmenopausal women. Hacettepe University Graduate School Health Sciences, Obstetrics and Gynecological Nursing Programme, Doctorate Thesis, Ankara, 2021. This study was conducted as a randomized pretest-posttest study to examine the effect of sexual counseling based on the PLISSIT model on post-menopausal women's sexual functions, marital adjustment and quality of sexual life. Sixty women (Experimental=30, Control=30) that applied to the menopause policlinic of a Women Diseases Training and Research Hospital were included in the study. Two women dropped out later, so the study was completed with 58 (Experimental=29, Control=29) women. Firstly, women were separated into two groups according to the cut-point of (26,55) in The Female Sexual Function Index (those who score 26,6 and above or 26,5 and below) and then these two groups were divided into intervention and control groups randomly. Data were collected with Descriptive Questions Form, The Female Sexual Function Index, Marital adjustment Scale and Sexual Quality of Life Questionnaire Scale - Female Version between September 07, 2020 and March 26, 2021. Women were asked to fill the demographic questions form and survey forms based on their own self-evaluations while they were accompanied by the researcher. The intervention group was given sexual counselling, prepared in line with the PLISSIT model, for three weeks, once a week and lasting approximately one hour. The effect of the counseling was tested twelve weeks after counseling was completed. Women in the control group were also interviewed twice concurrent with the intervention group; once when the counseling began and once during the last assessment. During those interviews, women in the control group filled some data forms. After the study was completed, the counseling was also given to women who wanted it, in the control group. Frequency and percentage values, descriptive statistics, Fisher's Exact Test, Pearson Chi Square, t tests, for non-normally distributed data Mann Whitney U test and the Wilcoxon test were used for data analysis.
Keywords: Post-menopausal period, sexual counseling, PLISSIT model, nursing care
- Conditions
- Postmenopause, Sexual Function, Marital Relationship
- Being tested
- Sexual counseling according to the PLISSIT model, randomized pretest-posttest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual counseling according to the PLISSIT model, randomized pretest-posttestOther
experimental and control ,a randomized pretest-posttest study to examine
| Study group | Role | What they receive |
|---|---|---|
| Sexual counseling intervention group according to the PLISSIT model | Experimental | Sexual counseling according to the PLISSIT model, randomized pretest-posttest Receives: Other: Sexual counseling according to the PLISSIT model, randomized pretest-posttest |
| control | Experimental | Non-counseling group Receives: Other: Sexual counseling according to the PLISSIT model, randomized pretest-posttest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index
Rosen et al [2000] developed this scale. It includes 19 items. Responses to some items range from 0 to 5 while others range from 1 to 5. The scores are summed up to create single Female Sexual Function Index score that ranges from 2 to 36. Higher scores mean better sexual functions.
Measured: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
Marital Adjustment Subscale
It was developed by Locke and Wallace (1959) and consists of 15 items. The validity and reliability for Turkish translation was conducted by Kışlak-Tutarel (1999). The response range for the items are as the following: Item 1 = 0-6 points, Item 2 to 9 = 0-5 points, Items 10, 12, and 14 = 0-2 points, Items 11 and 13 = 0-3 points, and Item 15 = 0-2 points. The scale minimum value is 0 and maximum value is 58. Higher scores mean better marital adjustment.
Measured: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
The Sexual Quality Of Life-Female
It was developed by Symonds et al (2005) and consists of 18 items. Items are scored from 0 to 5. The scale minimum value is 0 and maximum value is 90. Higher scores mean better sexual quality in a women's life.
Measured: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
Menopause Rating Scale
It was developed by Schneider et al (1992) The Turkish validity and reliability study was carried by Gürkan (2005). The scale has a minimum value of 0 and a maximum value of 44. Higher scores mean more symptoms in menopause.
Measured: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start28 Sep 2020
- Primary completion26 Dec 2020
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample was divided into intervention and control groups sexual counseling based on the PLISSIT model
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Sevim AKBAY KISA, Suleyman Demirel University
- Investigators
- Gülten HÜ Koç, asst. prof., Study director, Hacettepe UniversityBerna EH Dilbaz, professor, Study chair, Etlik Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448079
- Sponsor's protocol ID
- SuleymanDUAyşeAKBAYKISA-001
- Status last verified
- Jul 2022
- First submitted
- 24 May 2022
- Last updated
- 7 Jul 2022
- Results posted
- 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 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Counseling Given According to the PLISSIT Model on Sexual Functions, Marital Adjustment and Quality of Sexual Life of Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05448079
- Acronym / sponsor ID
- SuleymanDUAyşeAKBAYKISA-001
- Conditions
- Postmenopause, Sexual Function, Marital Relationship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 26 Dec 2020 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 7 Jul 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 was conducted as a randomized pretest-posttest study to examine the effect of sexual counseling based on the PLISSIT model on post-menopausal women's sexual functions, marital adjustment and quality of sexual life. Sixty women (Experimental=30, Control=30) that applied to the menopause policlinic of a Women Diseases Training and Research Hospital were included in the study. Two women dropped out later, so the study was completed with 58 (Experimental=29, Control=29) women. Firstly, women were separated into two groups according to the cut-point of (26,55) in The Female Sexual Function Index (FSFI) (those who score 26,6 and above or 26,5 and below) and then these two groups were divided into intervention and control groups randomly. Data were collected with Descriptive Questions Form, Menopause Symptom Evaluation Scale (MRS), FSFI, Marital adjustment Scale (MAS) and Sexual Quality of Life Questionnaire Scale - Female Version (SQOL-F) between September 07, 2020 and March 26, 2021. The intervention group was given sexual counselling, prepared in line with the PLISSIT model, for three weeks, once a week and lasting approximately one hour. The effect of the counseling was tested twelve weeks after counseling was completed. Women in the control group were also interviewed twice concurrent with the intervention group; once when the counseling began and once during the last assessment. Women in the control group filled some data forms. After the study was completed, the counseling was also given to women who wanted it, in the control group. Frequency and percentage values, descriptive statistics, Fisher's Exact Test, Pearson Chi Square, t tests, for non-normally distributed data Mann Whitney U test and the Wilcoxon test were used for data analysis.
Keywords: Post-menopausal period, sexual counseling, PLISSIT model, nursing care
Detailed description
Akbay-Kısa, A. S., The effect of sexual counseling given according to the PLISSIT model on sexual functions, marital adjustment and quality of sexual life of postmenopausal women. Hacettepe University Graduate School Health Sciences, Obstetrics and Gynecological Nursing Programme, Doctorate Thesis, Ankara, 2021. This study was conducted as a randomized pretest-posttest study to examine the effect of sexual counseling based on the PLISSIT model on post-menopausal women's sexual functions, marital adjustment and quality of sexual life. Sixty women (Experimental=30, Control=30) that applied to the menopause policlinic of a Women Diseases Training and Research Hospital were included in the study. Two women dropped out later, so the study was completed with 58 (Experimental=29, Control=29) women. Firstly, women were separated into two groups according to the cut-point of (26,55) in The Female Sexual Function Index (those who score 26,6 and above or 26,5 and below) and then these two groups were divided into intervention and control groups randomly. Data were collected with Descriptive Questions Form, The Female Sexual Function Index, Marital adjustment Scale and Sexual Quality of Life Questionnaire Scale - Female Version between September 07, 2020 and March 26, 2021. Women were asked to fill the demographic questions form and survey forms based on their own self-evaluations while they were accompanied by the researcher. The intervention group was given sexual counselling, prepared in line with the PLISSIT model, for three weeks, once a week and lasting approximately one hour. The effect of the counseling was tested twelve weeks after counseling was completed. Women in the control group were also interviewed twice concurrent with the intervention group; once when the counseling began and once during the last assessment. During those interviews, women in the control group filled some data forms. After the study was completed, the counseling was also given to women who wanted it, in the control group. Frequency and percentage values, descriptive statistics, Fisher's Exact Test, Pearson Chi Square, t tests, for non-normally distributed data Mann Whitney U test and the Wilcoxon test were used for data analysis.
Keywords: Post-menopausal period, sexual counseling, PLISSIT model, nursing care
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sample was divided into intervention and control groups sexual counseling based on the PLISSIT model
| Arm | Type | Receives |
|---|---|---|
| Sexual counseling intervention group according to the PLISSIT model | Experimental | Other: Sexual counseling according to the PLISSIT model, randomized pretest-posttestSexual counseling according to the PLISSIT model, randomized pretest-posttest |
| control | Experimental | Other: Sexual counseling according to the PLISSIT model, randomized pretest-posttestNon-counseling group |
Who may qualify
- Ages
- 42 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Being in the first year of postmenopause,
- Living with spouse/partner,
- Having an active sex life,
- Being able to speak, understand and read Turkish,
- Entering menopause naturally,
Key exclusion criteria (5 listed)
- Receiving sexual health counseling from another consultant during the working period,
- Desiring to leave the research at any stage of the research,
- Failure to attend at least one of the sexual health counseling sessions,
- Not participating in the post-test,
- Getting a diagnosis of COVID.
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 counseling according to the PLISSIT model, randomized pretest-posttestexperimental and control ,a randomized pretest-posttest study to examine | Other | Sexual counseling intervention group according to the PLISSIT model, control |
Primary outcome
Female Sexual Function Index
Time frame: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
Rosen et al [2000] developed this scale. It includes 19 items. Responses to some items range from 0 to 5 while others range from 1 to 5. The scores are summed up to create single Female Sexual Function Index score that ranges from 2 to 36. Higher scores mean better sexual functions.
Marital Adjustment Subscale
Time frame: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
It was developed by Locke and Wallace (1959) and consists of 15 items. The validity and reliability for Turkish translation was conducted by Kışlak-Tutarel (1999). The response range for the items are as the following: Item 1 = 0-6 points, Item 2 to 9 = 0-5 points, Items 10, 12, and 14 = 0-2 points, Items 11 and 13 = 0-3 points, and Item 15 = 0-2 points. The scale minimum value is 0 and maximum value is 58. Higher scores mean better marital adjustment.
The Sexual Quality Of Life-Female
Time frame: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
It was developed by Symonds et al (2005) and consists of 18 items. Items are scored from 0 to 5. The scale minimum value is 0 and maximum value is 90. Higher scores mean better sexual quality in a women's life.
Menopause Rating Scale
Time frame: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
It was developed by Schneider et al (1992) The Turkish validity and reliability study was carried by Gürkan (2005). The scale has a minimum value of 0 and a maximum value of 44. Higher scores mean more symptoms in menopause.
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 7 Jul 2022.
- 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.
Gülten HÜ Koç, asst. prof. study director
Hacettepe University
Berna EH Dilbaz, professor study chair
Etlik Hastanesi
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 counseling according to the PLISSIT model, randomized pretest-posttest in people with Postmenopause and Sexual Function, run by Suleyman Demirel 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 16 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: finished, as of the sponsor's last update on 7 Jul 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?
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?
Female Sexual Function Index (time frame: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.). The study lists 4 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 7 Jul 2022.