Education and Counseling Program Based on the Health Promotion Model

NCT05898386 | Completed DMC

• 1 other identifier: 2019-06
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence; Behavior and Lifestyle Changes; Pender's Health Promotion Model; Self-Esteem; Sexual Satisfaction; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Urinary incontinence severity

  'Incontinence Severity Index' was used to measure urinary incontinence severity. ISI was developed by Sandvik et al. (1993) in Norway to assess the severity of UI in women with UI. ISI is a simple assessment method that can be applied easily. The validity and reliability study of ISI was conducted by Hazar and Şirin (2008), Cronbach α coefficient was 0.67; validity coefficient was determined as r=0.963 and r=0.932. In this study, the Cronbach α coefficient of ISI was found to be 0.79. The ISI score is calculated by multiplying the score obtained from the first question with the score obtained from the second question. Although the total score varies between 1-12; If the total ISI score is between 1-2 points, it is considered as mild, between 3-6 points as moderate, between 8-9 points as severe, and if 12 points as very severe incontinence.

  Change from Urinary Incontinence Severity at 3 months.

Secondary Outcomes (4)

• Frequency of urinary incontinence

  Change from Frequency of urinary incontinence at 3 months.

• Quality of Life of women with urinary incontinence

  Change from Quality of Life at 3 months.

• Sexual Satisfaction

  Change from Sexual Satisfaction at 3 months.

• Self-esteem

  Change from Self-esteem at 3 months.

Study Arms (2)

Control Group

NO INTERVENTION

No intervention was made in the control group. The women in the control group were called during the 3-month follow-up to ask whether they received treatment for urinary incontinence simultaneously with the telephone calls of the intervention group.

Intervention Group

EXPERIMENTAL

A training and counseling program based on the pender's health promotion model was applied to the intervention group. After the training, 3 home visits and 3 phone calls were made to support the implementation of behavioral and lifestyle changes in coping with urinary incontinence.

Behavioral: Behaviour and Lifestyle Changes in Urinary Incontinence

Interventions

Behaviour and Lifestyle Changes in Urinary Incontinence BEHAVIORAL

The women included in the second stage were given a pre-test before the training program. Training program included behavioral and lifestyle changes in coping with urinary incontinence After the training program, the women applied behavior and lifestyle changes for 3 months. 3 home visits, 3 phone calls and 3 follow-ups were made.

Also known as: Education and counseling program based on the 'Pender's Health Promotion Model', Behavior and lifestyle changes training and counseling program in coping with urinary incontinence

Intervention Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Esra Başkaya

Ankara, Eryaman, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence; Behavior; Orgasm

Interventions

Educational Status; Coping Skills

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: June 12, 2023
• Study Start: January 17, 2021
• Primary Completion: January 13, 2022
• Study Completion: January 13, 2022
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

TU (1)