The Effect of Sexual Counseling Given According to the PLISSIT Model on FSFI, MAS and SQOL-F of Postmenopausal Women

NCT05448079 | Completed

• 1 other identifier: SuleymanDUAyşeAKBAYKISA-001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Postmenopause; Sexual Function; Marital Relationship

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  28.09.2020- 02.04.2021. The research period for a participant takes approximately four months.

Study Arms (2)

Sexual counseling intervention group according to the PLISSIT model

EXPERIMENTAL

Sexual counseling according to the PLISSIT model, randomized pretest-posttest

Other: Sexual counseling according to the PLISSIT model, randomized pretest-posttest

control

EXPERIMENTAL

Non-counseling group

Other: Sexual counseling according to the PLISSIT model, randomized pretest-posttest

Interventions

Sexual counseling according to the PLISSIT model, randomized pretest-posttest OTHER

experimental and control ,a randomized pretest-posttest study to examine

Sexual counseling intervention group according to the PLISSIT model; control

Eligibility Criteria

• Age: 42 Years - 55 Years
• Gender Eligibility Details: Postmenopause, female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University

Isparta, 32500, Turkey (Türkiye)

Location

Study Officials

• Gülten HÜ Koç, asst. prof.

  Hacettepe University

  STUDY DIRECTOR

• Berna EH Dilbaz, professor

  Etlik Hastanesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The sample was divided into intervention and control groups sexual counseling based on the PLISSIT model

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: July 7, 2022
• Study Start: September 28, 2020
• Primary Completion: December 26, 2020
• Study Completion: February 26, 2021
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)