The Effect of Counseling Based on the Roy Adaptation Model on Sexual Life and Quality of Life in Menopause

NCT06605742 | Completed

• 1 other identifier: 9199
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, it was aimed to determine the effect of the support and counseling program based on the Roy Adaptation Model given to postmenopausal women with Genitourinary Syndrome on their sexual life and quality of life.

Conditions

Genitourinary Syndrome of Menopause; Female; Postmenopause

Keywords

Genitourinary Syndrome in Menopause; Roy's Adaptation Model; Sexual Health; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Sexual functions

  FSFI (Female Sexual Function Index) was used to evaluate sexual function. FSFI is a 19-item scale developed by Rosen et al. (2000) to evaluate female sexual function. Turkish validity and reliability study was conducted by Öksüz and Malhan in 2005. FSFI evaluates sexual function or problems involving the last four weeks. A minimum raw score of 4 and a maximum raw score of 95 can be obtained from the scale. After scoring by multiplying the effect coefficients determined for the sub-dimensions, the lowest score is 2 and the highest score is 36, and as the score increases, sexual functions are maintained more adequately.

  5 months

• The quality of life of postmenopausal women

  The Menopause Specific Quality of Life Questionnaire- MENQOL was used to assess quality of life. MENQOL is a self-administered tool developed by Hilditch et al. (1996) to assess the quality of life of menopausal women. The Turkish validity and reliability study of the scale was conducted by Kharbouch and Şahin. In MENQOL, each question item is scored between 1-8 points. A score of 1 indicates that there is no problem related to that issue, a score of 2 indicates that the issue exists but is not disturbing at all, and scores between 3-8 indicate the severity of the existing problem. A low score indicates a high quality of life in women.

  5 months

• Vaginal symptoms

  The International Consultation on Incontinence Questionnare-Vaginal Symptoms (ICIQVS) was used to evaluate vaginal symptoms. The ICIQ-VS scale was developed by Price et al. in 2006. Turkish validity and reliability study was conducted by Rüstemoğlu and Aslan (2021). The ICIQ-VS scale consists of 14 questions, 25 items with sub-questions, and 3 sub-dimensions (vaginal symptoms, sexual issues and quality of life).

  5 months

• Depression

  Beck Depression Scale was used to evaluate depression. It was developed by Beck et al. The Turkish validity and reliability study was conducted by Hisli in 1989. The BDI consists of 21 items assessing the severity of depression. The total score for the whole scale ranges from 0 to 63 points. The degree of depression is indicated by the total score

  5 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

A Support and Counseling Program Based on the Roy Adaptation Model and a training booklet were prepared for women diagnosed with MGS. During the study, 5 counseling sessions were held for 4 months (16 weeks).

Other: Consultancy

Control Grup

EXPERIMENTAL

Women in the control group received routine care from the hospital. They filled out the scales at the first and last interviews. At the first interview, women in the control group were given an educational booklet.

Other: Consultancy

Interventions

Consultancy OTHER

In the single-blind method, subjects do not know which of the experimental or control groups they were selected and therefore which method was applied to them.The researcher knows the subjects selected for the experimental and control groups, and therefore which method was applied to which subjects

Also known as: Randomized Controlled Experimental Design

Control Grup; Experimental Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Postmenopausal women diagnosed with Genitourinary Syndrome in Menopause
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Those between the ages of 40-60
• Verbal communication established
• Having an active sex life
• No menstruation for at least 1 year
• It has been determined that she has entered menopause with the hormone value in the blood (FSH above 25).
• Women who agree to participate in the study will be included in the sample group.

You may not qualify if:

• Those with advanced prolapse
• Those with Urinary Incontinence
• Those with systemic HRT
• Those who have neurological or psychiatric disorders, use antidepressants and derivatives
• Women who do not agree to participate in the research will be excluded from the study.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

İstanbul University-Cerrrahpaşa

Istanbul, 34381, Turkey (Türkiye)

Location

Related Publications (3)

• Aliei MM.,Ghelichkhani F., Pakghohar M., Abadi MMM.,2016, Effectiveness of a sex education program on sexual function in postmenopausal women with sexual dysfunction: A randomized tria,In: Payesh, Vol 15, Iss 2, Pp 181-192.

  BACKGROUND

• Angelou K, Grigoriadis T, Diakosavvas M, Zacharakis D, Athanasiou S. The Genitourinary Syndrome of Menopause: An Overview of the Recent Data. Cureus. 2020 Apr 8;12(4):e7586. doi: 10.7759/cureus.7586.

  PMID: 32399320 BACKGROUND

• ACOG Practice Bulletin No. 141: management of menopausal symptoms. Obstet Gynecol. 2014 Jan;123(1):202-216. doi: 10.1097/01.AOG.0000441353.20693.78.

  PMID: 24463691 BACKGROUND

Study Officials

• Arzu Msc Akdemir

  İstanbul University-Cerrrahpaşa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In the single-blind method, subjects do not know which of the experimental or control groups they were selected and therefore which method was applied to them.The researcher knows the subjects selected for the experimental and control groups, and therefore which method was applied to which subjects.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Controlled Experimental Design

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: September 20, 2024
• Study Start: November 1, 2021
• Primary Completion: May 6, 2022
• Study Completion: November 30, 2022
• Last Updated: September 20, 2024

Record last verified: 2024-08

Locations

TU (1)