Clinical trial NCT05448079: The Effect of Sexual Counseling Given According to the PLISSIT Model on FSFI, MAS and SQOL-F of Postmenopausal Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopause
Sexual Function
Marital Relationship
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 58
Sex: FEMALE
Minimum age (years): 42
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample was divided into intervention and control groups sexual counseling based on the PLISSIT model
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

1. Being in the first year of postmenopause,
2. Living with spouse/partner,
3. Having an active sex life,
4. Being able to speak, understand and read Turkish,
5. Entering menopause naturally,
6. Living within the borders of Ankara province,
7. Not having menopause at an early or late age (over 40 years and under 55 years old),
8. Not taking hormone replacement therapy,
9. Not using herbal treatment for menopause (containing estrogen),
10. Not having a type of cancer that may affect sexual function,
11. Not receiving chemotherapy / radiotherapy,
12. No health problems (Hypertension, Diabetes, Cardiovascular disease, Urinary incontinence),
13. Not having a mental illness and/or not using drugs (antipsychotic drugs, Spironolactone, etc.),
14. Not being diagnosed with COVID in the last month,
15. Not having a sexual dysfunction diagnosis / treatment history in himself or his partner,
16. Not getting sexual health counseling before.

Exclusion Criteria:

1. Receiving sexual health counseling from another consultant during the working period,
2. Desiring to leave the research at any stage of the research,
3. Failure to attend at least one of the sexual health counseling sessions,
4. Not participating in the post-test,
5. Getting a diagnosis of COVID.

Primary outcomes:
measure: Female Sexual Function Index
timeFrame: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
measure: Marital Adjustment Subscale
timeFrame: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
measure: The Sexual Quality Of Life-Female
timeFrame: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
measure: Menopause Rating Scale
timeFrame: 28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
Study officials:
affiliation: Hacettepe University
name: Gülten HÜ Koç, asst. prof.
role: STUDY_DIRECTOR
affiliation: Etlik Hastanesi
name: Berna EH Dilbaz, professor
role: STUDY_CHAIR
References: