NCT04689113

Brief Summary

Background: The aim of this study is to determine the effect of "Incontinence Health Belief Development Program" on urinary incontinence awareness and health beliefs of women in premenopausal period.The research was conducted in a randomized controlled double-blind pretest-posttest control group experimental research design type.The data of the research were collected in Samsun / Atakum District Healthy Life Center and three Family Health Centers. The study was completed with 76 women in the experimental group and 77 women in the control group. The pre-test data of the study were collected using the sociodemographic characteristics information form , the Incontinence Awareness Scale (ISI), the "Health Belief Scale for Urinary Incontinence and Kegel Exercise" and the "Broome Pelvic Muscle Self-Efficacy Scale" for the experimental and control groups.A 5-week "Incontinence Health Belief Development Program" was applied to the experimental group. Posttests were applied to the experimental and control groups 3 months after the program. Descriptive statistics, paired t test, chi-square, Mann-Whitney U, Wilcoxon analysis were used in the analysis of the data. What does this paper contribute? \*Urinary incontinence awareness, health belief on urinary incontinence and kegel exercise and pelvic muscle self-efficacy of women increased after the Incontinence Health Belief Development Program based on the health belief model.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

December 9, 2020

Last Update Submit

April 1, 2021

Conditions

Keywords

kegel exerciseurinary incontinenceAwarenessHealth Belief ModelTrainingRandomization

Outcome Measures

Primary Outcomes (3)

  • Incontinence Awareness Scale

    The urinary incontinence awareness scale, developed by Avci et al. (2017) to measure individuals' awareness of urinary incontinence, consists of 26 items. It consists of 5 sub-dimensions: factors that prevent it from being accepted as a health problem, coping with urinary incontinence, health motivation, restriction and fear of urinary incontinence. The scale does not have a total score.Having a high score in the factors preventing its acceptance as a health problem indicates that it accepts urinary incontinence as a health problem.High scores on the sub-dimensions of restriction and incontinence indicate that he does not have a fear of restriction and urinary incontinence.Low scores on the health motivation and coping with urinary incontinence sub-dimensions indicate that their health motivation and coping with urinary incontinence are betterence.

    3 month

  • Health Belief Scale for Urinary Incontinence and Kegel Exercise

    The scale consists of 49 questions in 5-point likert type. Scale items are separated according to susceptibility, seriousness, health motivation, Kegel exercise benefit perception, Kegel exercise barrier perception and self-efficacy subdimensions created according to health belief model. There is no total score of the scale. Increasing scores indicate positive perception for susceptibility, seriousness, health motivation, Kegel exercise benefit perception and self-efficacy subdimensions and negative perception for Kegel exercise barrier perception. Increasing scores mean that susceptibility, seriousness and motivation increase; that benefits are perceived high for benefit perception while barriers are perceived high for barrier perception.

    3 month

  • Broome Pelvic Muscle Self-Efficacy Scale

    The scale, which consists of 23 statements in total, consists of two sub-dimensions: "effectiveness expectation" and "result expectation". Total scale score is determined by taking the average of the scores obtained from all expressions in the scale. The sub-dimension score is calculated by the average of the total score of the expressions of that dimension. The total score of the scale varies between 0-100; A score of 32 or less indicates low self-efficacy, 33-66 points medium, and a score above 66 indicates high self-efficacy. The validity and reliability of the scale is Cronbach's alpha: 0.95.

    3 month

Study Arms (2)

Intervention Group

EXPERIMENTAL

ıntervention group After determining the women according to the research criteria, they were randomized into intervention and control groups.Firstly, Pre-tests were applied to the women in the experimental group. The Incontinence Health Belief Development Program was applied to the women in the experimental group as 5 sessions.This program includes the following topics; urinary system anatomy and physiology, urinary incontinence and risk factors, definition of kegel exercise and its place in urinary incontinence treatment, kegel exercise applied expression, health motivation. A WhatsApp group was established to remind women in the intervention group about the kegel exercise 3 times a day for 3 months to increase their self-efficacy. In addition, a facebook group was opened and posts about urinary incontinence and kegel exercises were made. Posttests were made 3 months after the training ended

Behavioral: Incontinence Health Belief Development Program

Control Group

NO INTERVENTION

Firstly, Pre-tests were applied to the women in the control group. No intervention was applied to this group.Posttests were made 3 months after pre-test.

Interventions

After the applied interventions, it is desired to develop kegel exercise behavior in women.

Intervention Group

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince the prevalence of urinary incontinence increases during menopause, only women in the premenopausal period were recruited.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a woman over the age of 45 in the premenopausal period who has not entered menopause
  • Being able to communicate and volunteer
  • Not having urinary incontinence
  • Absence of a disease affecting the genital and urinary system (based on self-report)
  • Using a smart mobile phone (to be included in Facebook and whatsapp groups)
  • There is no obstacle to doing Kegel exercise

You may not qualify if:

  • Having entered the menopause period
  • Refusing to participate in research
  • Having a problem with the genito-urinary system Previous treatment for urinary incontinence
  • Not having a smart mobile phone
  • Not using Facebook and Whatsapp Having urinary incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liv Hospital Samsun

Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • İlknur Aydin AVCİ, Prof

    Ondokuz Mayıs University

    STUDY DIRECTOR
  • Yakup BOSTANCI, Assoc.Prof.

    Ondokuz Mayıs University

    STUDY CHAIR
  • Eren Yıldırım, Dr.

    Liv Hospital Samsun

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Nursing Department

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 30, 2020

Study Start

November 1, 2019

Primary Completion

September 1, 2020

Study Completion

November 1, 2020

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to \[restrictions e.g. their containing information that could compromise the privacy of research participants\].

Locations