Clinical trial NCT05898386: Education and Counseling Program Based on the Health Promotion Model
Official title: The Effect of Education and Counseling Program Based on the Health Promotion Model on Self-Esteem, Sexual Satisfaction and Quality of Life in Women With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Behavior and Lifestyle Changes
Pender's Health Promotion Model
Self-Esteem
Sexual Satisfaction
Quality of Life
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The first phase of the study was carried out to determine the prevalence and risk factors of urinary incontinence in non-menopausal women over 18 years of age registered in a Family Health Center.

The second phase of the study was carried out to examine the effects of the education and counseling program based on the 'Pender's Health Promotion Model' on women's self-esteem, sexual satisfaction and quality of life in women with urinary incontinence.

Research Questions

What is the prevalence of UI in non-menopausal women over the age of 18 who are registered with the Family Health Center? What are the risk factors for urinary incontinence?

Research Hypotheses

H1: There is a difference between the urinary incontinence severity levels of women who received and did not receive education and counseling program based on Pender's health promotion model.

H2: There is a difference between the self-esteem levels of women who received and did not receive a training and counseling program based on Pender's health promotion model.

H3: There is a difference between the sexual satisfaction levels of women who received and did not receive the training and counseling program based on Pender's health promotion model.

H4: There is a difference between the quality of life levels of women who received training and counseling programs based on Pender's health promotion model and those who did not.

In the second stage of the study, the 'Training and Counseling Program Based on Pender's Health Promotion Model' and 'Home Monitoring and Counseling Program' were applied to the intervention group, which was prepared according to Pender's Health Promotion Model.

During the three-month period, the intervention group received 3 home visits one, two and three months after the training program, and 3 phone calls 15 days after the training program and each home visit.

No intervention was made in the control group; Data collection forms were applied simultaneously with the intervention group and they were reminded that they were in the research by making a phone call.

Detailed description: The research was carried out in two stages.

In the first phase of the study, in a cross-sectional research design, in order to determine the prevalence and risk factors of urinary incontinence in women who are over 18 years old and who are not menopausal, registered in a Family Health Center; In this study, a pretest-posttest randomized controlled experimental research design was conducted to evaluate the effect of education and counseling program based on Pender's Health Promotion Model on self-esteem, sexual satisfaction and quality of life in women with second-stage urinary incontinence.

In the first phase of the study, 1042 women over the age of 18 who were registered at the Family Health Center and who did not go through menopause were included.

In the first stage, the data; It was collected between 18 January 2021 and 31 May 2021, using the 'Questionnaire on Descriptive Characteristics', 'International Incontinence Inquiry Form' and 'Incontinence Severity Index'.

The second stage of the study continued with 46 women who met the sample selection criteria for the second stage.

After the pre-test was completed, 46 women were assigned to the intervention and control groups (M:23, F:23) by stratified block randomization and stratified according to urinary incontinence severity (mild, moderate).

In the second stage of the research, the data; Between September 24, 2021 and January 13, 2022, 'International Incontinence Inquiry Form', 'Incontinence Severity Index', 'Information Form Based on Pender's Health Promotion Model', 'Self-Esteem Sub-Scale', 'Golombok-Rust Sexual Satisfaction Scale- It was collected using the 'Female Form', 'Incontinence Quality of Life Scale', 'Self-Efficacy/Efficacy Scale'.

In the second stage of the study, the 'Training and Counseling Program Based on Pender's Health Promotion Model' and 'Home Monitoring and Counseling Program' were applied to the intervention group, which was prepared according to Pender's Health Promotion Model.

During the three-month period, the intervention group received 3 home visits one, two and three months after the training program, and 3 phone calls 15 days after the training program and each home visit.

No intervention was made in the control group; Data collection forms were applied simultaneously with the intervention group and they were reminded that they were in the research by making a phone call.

In both stages of the study, the forms and scales were filled by the women themselves, and the women were guided during this period.

Frequency, percentage and descriptive statistics for data evaluation, Shapiro-Wilk Test, Independent Samples T-Test, Repeated Measurements Anova Test, Chi-square Test of Independence, Fisher Test, Cochran-Q Test, Mann-Whitney U Test, McNemar Test, Friedman Test and Marginal Homogeneity Test were used.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old,
* Having at least primary education level,
* Not having any mental problems,
* Not being in the pregnancy period,
* No active vaginal or urinary tract infection or gynecological malignancy,
* Not having received conservative treatment for urinary incontinence in the last 6 months,
* Not having had pelvic surgery in the last 2 months,
* No pelvic organ prolapse (POP) on stage 2,
* Mild to moderate UI,
* Not having reached menopause (diagnosed with menopause or no menstruation in the last 12 months)
* Having regular sexual intercourse,
* Not using drugs that may affect UI.

Exclusion Criteria:

* Having to take medical or surgical treatment that may affect the intervention due to a problem other than urinary incontinence during the follow-up period,
* Pregnancy during the follow-up period,
* Completion of all steps of the research.

Primary outcomes:
measure: Urinary incontinence severity
timeFrame: Change from Urinary Incontinence Severity at 3 months.
Secondary outcomes:
measure: Frequency of urinary incontinence
timeFrame: Change from Frequency of urinary incontinence at 3 months.
measure: Quality of Life of women with urinary incontinence
timeFrame: Change from Quality of Life at 3 months.
measure: Sexual Satisfaction
timeFrame: Change from Sexual Satisfaction at 3 months.
measure: Self-esteem
timeFrame: Change from Self-esteem at 3 months.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Esra Başkaya
state: Eryaman
Study officials:
References: