Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04689113 |
| Other study ID # |
B.30.2.ODM.0.20.08/111-224 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2019 |
| Est. completion date |
November 1, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
Ondokuz Mayis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Aim of study 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.
Study design ans setting The research was conducted in a randomized controlled double-blind
pretest-posttest control group experimental research design type. To avoid bias the
participants were not told whether they were in the experimental or the control group. The
randomized clinical trial was based on the guidelines proposed by the Consolidated standard
of Reporting Trials- CONSORT 2010. The data of the research were collected in Samsun / Atakum
District Healthy Life Center and three Family Health Centers between November 2019- September
2020.
Randomization An intervention group and a control group formed using the research randomizer
software. the program used random numbers to select participants and randomly assign them to
the experimental or control group(total 160 women, each group 80 women).
Blinding of data collectors and statistician was implemented in this randomized blinded
study. another researcher who did not know the group assignments coded the data in the
computer. after statistical analysis was conducted and research report was written, assistant
researcher explained tge codes for experimental and control group. Therefore, blinding of the
collectors, statistical analysis and report writing was provided.
Implementing the Incontinence Health Belief Development Program The trainings were applied to
the women in the experimental group in groups of 10 in the Atakum Healthy Life Center in 5
sessions of 45-60 minutes and 5 weeks. For 5 weeks, 8 group trainings were conducted by
taking two different groups every week, 4 days a week. Also Establishing Whatsapp and
Facebook Groups 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.
Data Collection Tools 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.
Introductory Question Form: Introductory question form was developed by the researcher and
consists of questions involving sociodemographic characteristics, gynecological features and
urinary incontinence and kegel exercise of people (age, gender, marital status, education
status, etc.).
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. Scores obtained from sub-dimensions; For the factors preventing its acceptance
as a health problem sub-dimension, min 8, max 40; For health motivation sub-dimension, min 5,
max 25; For the sub-dimension of dealing with urinary incontinence, min 6, max 30; For
restriction sub-dimension min 3, max 15; For the subscale for fear of urinary incontinence,
the minimum is 4 and the maximum is 20. 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
better.
Health Belief Scale for Urinary Incontinence and Kegel Exercise: The scale developed by Avcı
and Yıldırım (2019) based on the health belief model to determine the beliefs of individuals
about urinary incontinence and kegel exercise, 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. Responses given to each statement in
the scale are in 5-point Likert type and all statements are positive. Scores obtained from
subdimensions vary between 9-45 for susceptibility subdimension; between 14-70 for
seriousness subdimension; between 5-25 for health motivation subdimension; between 7-35 for
Kegel exercise benefit perception subdimension; between 9-45 Kegel exercise barrier
perception subdimension and between 5-25 for self-efficacy subdimension. 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. Cronbach's alphas in the validity and reliability study of the scale are as
follows for the sub-dimensions: sensitivity: 0.89; severity: 0.91; health motivation: 0.79;
kegel exercise benefit perception: 0.94; kegel exercise barrier perception: 0,90;
self-efficacy: 0.89.
Broome Pelvic Muscle Self-Efficacy Scale: Developed by Broome (1999) to measure the
perception of self-efficacy in pelvic floor muscle exercise practice and to provide
clinicians with a valid and reliable measurement tool in pelvic floor muscle exercise, the
scale was validated in Turkish by Zengin and Pınar in 2012. 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.
Evaluation of Data SPSS 23.0 statistical package program (Statistical Package for the Social
Sciences, Chicago, Illinois) was used for statistical analysis and evaluation of the data.
Whether the data showed normal distribution was checked with the Kolmogorov-Smirnov test.
Independent samples t test and Mann Whitney U test were used to compare data between groups
according to normality test. Paired samples t test and Wilcoxon test were used to compare the
pre-test and post-test values within the group. The Chi-square test and two ratio tests were
used to analyze categorical data. Significance level was taken as p <.05.
Research Budget:
Financial support of the research provided by the Scientific and Technological Research
Council of Turkey (TUBITAK) 1002 Short-term Support Program (issue number 219S160).
Ethical aspects: Study approval was given by Ondokuz Mayıs University Clinical Research
Ethics Committee. (Decision No: B.30.2.ODM.0.20.08 / 111-224). All participants were informed
about tis study and obtained orat-written informed consents.
