Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04831463 |
| Other study ID # |
2019-91 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2020 |
| Est. completion date |
March 15, 2021 |
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
Aims The study aims to examine the effect of "IHAPIM" program on health perceptions, health
responsibilities, perceived stress level, attitudes towards utiling health care services and
the types of coping strategies of immigrant men.
Design This study is a two centre, double-blind, randomized controlled trial. Methods We
attempt to report this randomized controlled trial to comply with the SPIRIT. The study
population consist of 95 immigrant men live at north of Turkey. The study, between March
2020-March 2021 were held in the two district predominantly immigrants. The participants were
randomly divided into experimental and control group. The experimental (N = 49) received a
short-term IHAPIM program (5 week, 1 hr per week, 10 hr in total). Measurements were obtained
during pre- and post-test from experimental and control group (N = 46). In this study,
participants and statistician who conducted the research blinded.
Discussion The efficacy of health promotion interventions are known. However, the health
promotion interventions for immigrants men performed by public health nurse are not
available. At the same time, the effect of health promotion interventions for immigrants men
are unknown.
Impact This study is expected to provide a piece of credible evidence of the the health
promotion interventions for immigrants men performed by public health nurse and efficacy of
health perceptions, health responsibilities, perceived stress level, attitudes towards
utiling health care services and the types of coping strategies in immigrant men group. It is
assumed that health promotion interventions specific to male health and sensitive to the
language of immigrants lead to a beneficial results on health perceptions, health
responsibilities, perceived stress level, attitudes towards utiling health care services and
the types of coping strategies in immigrant men. If "IHAPIM" program perform in practice by
public heath nurse. It can be effectively improve immigrant men's health variables such as
health perceptions, health responsibilities, perceived stress level, attitudes towards
utiling health care services and the types of coping strategies.
Description:
This study was carried out in order to examine the effect of the "Increasising Health
Awareness Program for Immigrant Men " (IHAPIM), which was prepared based on the Transition
Theory of Meleis, on the health perceptions, health responsibilities, perceived stress
levels, attitudes towards utiling health care services and the types of coping strategies of
immigrant men.
This study, which was planned in accordance with the principles of a randomized controlled
double-blind pre-test post-test control group experimental study, was conducted with
immigrant males between the ages of 18 and 50, living in Canik and İlkadım districts of
Samsun, where immigrants live mainly. The randomized clinical trial was based on the
guidelines proposed by the SPIRIT 2013 Statement. The data of the study were collected in
Samsun / Ilkadım and Canık District between May 2020 and November 2020. Randomization an
experimental 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 95 immigrant men). In this study, immigrant men do not
know that they are in the experimental or control group, and the statistician who conducted
the research does not know which data belong to which group. Blinding is done in this way.
The study was completed with 49 men in the experimental group and 46 men in the control
group. The experimental (N = 49) received a short-term IHAPIM program by one-on-one interview
(5 week, 1 hr per week). The data of the study were collected using personal information
form, health perception scale, health responsibility sub-dimension of healthy lifestyle
behaviors scale, perceived stress scale, stress coping methods scale and the scale of
determining the attitudes of immigrants towards using health services.
personal information form; the form was developed by the researcher and consists of questions
involving sociodemographic characteristics (age, marital status, education status, etc.)
health perception scale; Health perceptions of immigrant men were evaluated with a visual
number scale. There is a question on the scale. Information on how to fill the scale as
parentheses information at the end of the question scored between 1-10, which is easy to
understand, which immigrant men can answer on their own ('0' on this scale indicates that you
evaluate your questioned situation very badly, the increase of the score is improving your
assessment of your questioned situation, and the '10' score is shows that your assessment of
your situation is very good).
health responsibility sub-dimension of healthy lifestyle behaviors scale; In measuring the
level of responsibility for an individual's health, the healthy lifestyle behaviors scale,
which was developed by Walker, Sechrist and Pender in 1987 and adapted to Arabic in 1998 by
Hadad et al. is the scale that determines the extent to which they participate in health. All
items of the healthy lifestyle behaviors scale are positive. There is no reverse matter.
Marking is done on 4 Likert type scales. A score of 1 is given for an answer "Never", 2
points for an answer "Sometimes", 3 points for an answer "Often" and 4 points for an answer
"Regularly". Health responsibility sub-dimension of healthy lifestyle behaviors scale 2, 7,
15,20,28,31,33,42,43,46. It consisted of a total of 10 items including items. The lowest
score is 10, the highest score is 40. The reliability coefficients of the scale are α 0.90.
perceived stress scale; The Perceived Stress Scale, developed by Cohen, Kamarc and
Mermelstein (1983), is the most commonly used tool of this type. Chaaya et al. In 2010, its
validity and reliability in Arabic was made. The scale consists of 10 items. It was developed
to evaluate to what extent the individual perceived his life as unpredictable, uncontrollable
or overloaded in the last month. The scale is in the 5-point Likert type (1- never, 2- almost
never, 3- sometimes, 4- often 5- very often), and its four items are reverse (4th, 5th, 7th,
8th items), six of its articles are plainly worded (1st, 2nd, 3rd, 6th, 9th, 10th items). The
lowest score that can be obtained from the scale is 0, and the highest score is 40. The scale
is evaluated over the total score, and the higher the scores indicate that the stress is
perceived high. The Arabic reliability coefficients of the scale are α 0.87.
types of coping strategies; The study of the "Ways of Coping Inventory" scale developed by
Folkman and Lazarus (1980) in order to determine the ways individuals use to deal with
general or significant stress situations, the Arabic validity and reliability was conducted
by Alghamdi (2020). The "Coping with Stress Scale" consists of two groups, 14 sub-dimensions
and 28 items, as compatible and incompatible. Harmonious coping methods; active coping,
positive reframing, planning, acceptance, religion, humor, using emotional social support
support), using useful social support (using instrumental support), incompatible coping
methods; behavioral disengagement, denial, substance use, focusing on the problem and
venting, mental self-distraction, self-blame. The Likert-type scale scored between 1 and 4
does not have a total score. Arabic validity and reliability study of the scale was conducted
in 2018 and the reliability coefficient was found to be α 0.80 in the Arabic version of the
scale.
the scale of determining the attitudes towards utiling health care services; Developed in
Arabic by Avci and Korkmaz in 2019 in order to determine the attitudes of immigrants towards
using health services, the scale for determining the attitudes of immigrants towards using
health services consists of 26 items. The scale consists of 4 sub-dimensions: health
awareness, factors affecting admission to health services, delivery of health services, and
access to health services. Answers given to each statement in the scale are in 5-point Likert
type and all statements are positive. Scores obtained from sub-dimensions: between 4-20
points for health awareness sub-dimension; Between 4-20 points for the factors affecting the
application to health services sub-dimension; It ranges between 5-25 points for the
sub-dimension of the way health services are provided and 5-25 points for the sub-dimension
of access to health services. The total scores obtained from the scale range from 18 to 90
points. The fact that the scores obtained from the scale subscale and the total score are
high indicates that the immigrants have a good attitude towards using health services.
Cronbach's alphas in the validity and reliability study of the scale are as follows:
Cronbach's Alpha reliability coefficient of the health awareness sub-dimension (0.63), the
Cronbach's Alpha reliability coefficient (0.73) of the factors affecting admission to health
services, the Cronbach's Alpha reliability coefficient of the sub-dimension of how health
services are provided (0.60), and Cronbach's Alpha reliability coefficient of access to
health services sub-dimension is (0.71). The total Cronbach's alpha reliability coefficient
of the scale for determining the attitudes of immigrants towards using health services is
0.72.
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.
Mann Whitney U test were used to compare data between groups according to normality test.
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 <0.05.
Funding: Financial support of the research provided by the Project Management Office of
Ondokuz Mayis University. PYO.SBF.1904.20.002.
Ethical aspects: Study approval was given by Ondokuz Mayıs University Ethıcs Commıttee For
Socıal And Humanıtıes Research. (Decision No: 2019-91). All participants were informed about
tis study and obtained orat-written informed consents.
