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Education and Counseling Program Based on the Health Promotion Model

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Behaviour and Lifestyle Changes in Urinary Incontinence
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Incontinence focused on measuring Urinary Incontinence, Behavior and Lifestyle Changes, Pender's Health Promotion Model, Self-Esteem, Sexual Satisfaction, Quality of Life

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Esra Başkaya

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Frequency of urinary incontinence
In the evaluation, the first, second and third dimensions are scored and the fourth dimension used in determining the UI type is not scored. The first dimension is scored as 0, 1, 2, 3, 4, 5, and the highest 5 and the lowest 0 points are taken from this dimension. The second dimension is scored as 0, 2, 4, 6, and the highest 6 and the lowest 0 points are taken from this dimension. The third dimension is scored as 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and the highest 10 and the lowest 0 points are taken from this dimension. The ICIQ-SF total score ranges from 0 to 21; A high score from the ICIQ-SF indicates that the quality of life of the individual is highly affected, while a low score indicates that it is less affected. Çetinel et al. (2007) in their study with 5565 women stated that when the ICIQ-SF total score is 8 and above, UI is in the dimension of disturbing and affecting daily life, and they determined 8 points as the cut-off point.
Quality of Life of women with urinary incontinence
I-QOL consists of three sub-dimensions: limitation of behavior, psychosocial influence, and social isolation. Limitation of behaviors sub-dimension 1st, 2nd, 3rd, 4th, 10th, 11th, 13th, 20th items, psychosocial impact sub-dimension 5th, 6th, 7th, 9th, 15th, 16th, 17th, 21th, 22nd items, and the social isolation sub-dimension includes 8th, 12th, 14th, 18th, and 19th items. The five-point Likert-type scale is evaluated with "a lot" (1), "a lot" (2), "moderately" (3), "a little" (4) and "not at all" (5). The calculation of the scale is based on the scores of the I-QOL total and sub-dimensions, and the sum of each item divided by the number of items. The calculated total score is converted into a scale value from 0 to 100. An increase in the total score is considered as an increase in the quality of life.
Sexual Satisfaction
'Golombok-Rust Inventory of Sexual Satisfaction-Women Form' was used to measure Sexual Satisfaction of women with urinary incontinence. GRISS, developed by Rust and Golombok (1986), is a measurement tool that evaluates sexual functions and the quality of sexual intercourse. The GRDCÖ-Female form consists of 28 items and 7 sub-dimensions: frequency of sexual intercourse, communication, satisfaction, avoidance, touch, vaginismus and anorgasmia. Items in the five-point Likert-type scale are evaluated with "never", "rarely", "sometimes", "mostly", "always" options. As the score obtained from the scale increases, the deterioration in sexual functions and the quality of the relationship increases. In the calculation of the scale, the score obtained from each sub-dimension is converted into standard scores ranging from 1 to 9. Scores of 5 and above from the sub-dimensions are considered to have a sexual problem related to that sub-dimension.
Self-esteem
. There are a total of 6 items and 10 questions in 'Self-Esteem Sub-Scale' 5 out of 10 questions are positive and 5 are negative. 1st, 2nd and 3rd questions constitute the first item, 4th and 5th questions constitute the second item, 6th question is the third item, 7th question is the fourth item, 8th question is the fifth item, and 9th and 10th questions are the sixth item. Items are evaluated with "very true", "correct", "false" and "very false" options. Each item is 1 point; The total score that can be obtained from the scale ranges from 0 to 6. For each item, "1" is given when the individual evaluates himself negatively, and "0" when he evaluates himself positively. As the score obtained from the scale increases, the self-esteem of the individual decreases. A score of 0-1 from the scale indicates a high level of self-esteem, a score of 2-4 indicates a moderate level of self-esteem, and a score of 5-6 indicates a low level of self-esteem.

Full Information

First Posted
March 21, 2023
Last Updated
June 23, 2023
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT05898386
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2021 (Actual)
Primary Completion Date
January 13, 2022 (Actual)
Study Completion Date
January 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary Incontinence, Behavior and Lifestyle Changes, Pender's Health Promotion Model, Self-Esteem, Sexual Satisfaction, Quality of Life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behaviour and Lifestyle Changes in Urinary Incontinence
Other Intervention Name(s)
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 Description
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.
Primary Outcome Measure Information:
Title
Urinary incontinence severity
Description
'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.
Time Frame
Change from Urinary Incontinence Severity at 3 months.
Secondary Outcome Measure Information:
Title
Frequency of urinary incontinence
Description
In the evaluation, the first, second and third dimensions are scored and the fourth dimension used in determining the UI type is not scored. The first dimension is scored as 0, 1, 2, 3, 4, 5, and the highest 5 and the lowest 0 points are taken from this dimension. The second dimension is scored as 0, 2, 4, 6, and the highest 6 and the lowest 0 points are taken from this dimension. The third dimension is scored as 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and the highest 10 and the lowest 0 points are taken from this dimension. The ICIQ-SF total score ranges from 0 to 21; A high score from the ICIQ-SF indicates that the quality of life of the individual is highly affected, while a low score indicates that it is less affected. Çetinel et al. (2007) in their study with 5565 women stated that when the ICIQ-SF total score is 8 and above, UI is in the dimension of disturbing and affecting daily life, and they determined 8 points as the cut-off point.
Time Frame
Change from Frequency of urinary incontinence at 3 months.
Title
Quality of Life of women with urinary incontinence
Description
I-QOL consists of three sub-dimensions: limitation of behavior, psychosocial influence, and social isolation. Limitation of behaviors sub-dimension 1st, 2nd, 3rd, 4th, 10th, 11th, 13th, 20th items, psychosocial impact sub-dimension 5th, 6th, 7th, 9th, 15th, 16th, 17th, 21th, 22nd items, and the social isolation sub-dimension includes 8th, 12th, 14th, 18th, and 19th items. The five-point Likert-type scale is evaluated with "a lot" (1), "a lot" (2), "moderately" (3), "a little" (4) and "not at all" (5). The calculation of the scale is based on the scores of the I-QOL total and sub-dimensions, and the sum of each item divided by the number of items. The calculated total score is converted into a scale value from 0 to 100. An increase in the total score is considered as an increase in the quality of life.
Time Frame
Change from Quality of Life at 3 months.
Title
Sexual Satisfaction
Description
'Golombok-Rust Inventory of Sexual Satisfaction-Women Form' was used to measure Sexual Satisfaction of women with urinary incontinence. GRISS, developed by Rust and Golombok (1986), is a measurement tool that evaluates sexual functions and the quality of sexual intercourse. The GRDCÖ-Female form consists of 28 items and 7 sub-dimensions: frequency of sexual intercourse, communication, satisfaction, avoidance, touch, vaginismus and anorgasmia. Items in the five-point Likert-type scale are evaluated with "never", "rarely", "sometimes", "mostly", "always" options. As the score obtained from the scale increases, the deterioration in sexual functions and the quality of the relationship increases. In the calculation of the scale, the score obtained from each sub-dimension is converted into standard scores ranging from 1 to 9. Scores of 5 and above from the sub-dimensions are considered to have a sexual problem related to that sub-dimension.
Time Frame
Change from Sexual Satisfaction at 3 months.
Title
Self-esteem
Description
. There are a total of 6 items and 10 questions in 'Self-Esteem Sub-Scale' 5 out of 10 questions are positive and 5 are negative. 1st, 2nd and 3rd questions constitute the first item, 4th and 5th questions constitute the second item, 6th question is the third item, 7th question is the fourth item, 8th question is the fifth item, and 9th and 10th questions are the sixth item. Items are evaluated with "very true", "correct", "false" and "very false" options. Each item is 1 point; The total score that can be obtained from the scale ranges from 0 to 6. For each item, "1" is given when the individual evaluates himself negatively, and "0" when he evaluates himself positively. As the score obtained from the scale increases, the self-esteem of the individual decreases. A score of 0-1 from the scale indicates a high level of self-esteem, a score of 2-4 indicates a moderate level of self-esteem, and a score of 5-6 indicates a low level of self-esteem.
Time Frame
Change from Self-esteem at 3 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Esra Başkaya
City
Ankara
State/Province
Eryaman
ZIP/Postal Code
06000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study data will be shared during publication

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Education and Counseling Program Based on the Health Promotion Model

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