Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04479085 |
| Other study ID # |
maldem |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Necmettin Erbakan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to examine the effect of nursing intervention to regulate the
home environment on symptom control and quality of life in children with allergic rhinitis.
Description:
Allergic rhinitis (AR) is a clinical picture resulting from one or more allergen
sensitivities. Seasonal AR develops due to grass, tree and grass pollen. Prennial AR develops
due to house dust mite, cockroaches, mold and pets.The prevalence of allergic rhinitis in
children ranges from 19.3-50.8%. AR affects school performance, sleep patterns and quality of
life in children.Children spend most of their lives in the home environment, and many studies
have shown that AR is associated with the home environment in children. Control measures
should be taken in patients' homes to prevent and reduce the symptoms of allergic rhinitis in
children. Awareness and education should be provided to families and children about the
importance of these measures.
This study is a pretest-posttest, parelel group, randomized controlled study study to examine
the effect of nursing intervention to regulate the home environment on symptom control and
quality of life in children with allergic rhinitis.
sample of the study; The effect size was intended to be medium effect size due to the absence
of a similar randomized controlled study to determine the quality of life in children with
allergic rhinitis. In the study, the number of samples to be included in the study with 0.7
medium effect size, power 80%, alpha reliability level 95%, 26 experiments and 26 controls
were calculated as 52 children and their mothers.
Randomized appointments were made in the appointment of 52 children and mothers who were
followed up with the diagnosis of allergic rhinitis, who included the criteria for inclusion
and exclusion, and who volunteered to participate in the study. Stratified randomization
method was used in this study. Stratified randomization method was used in this study. The
gender of the children (girls and boys), the age of the children (6-9 years, 10-12 years) and
the level of mother education (primary education, high school, university) were determined as
prognastic factors for stratification. Randomization was performed in a total of 52
participants, 26 experimental and 26 control groups.
Number, percentage, average and standard deviation will be used in the evaluation of the
descriptive data obtained from the research; Significance will be evaluated within 95%
confidence interval, p <0.05 will be taken.
The nursing attempt to organize the home environment for the experimental group will take 17
weeks. During this period, two home visits and two telephone calls will be made. During the
first home visit, training will be organized to regulate the home environment, as well as a
heat-moisture meter and anti-allergic duvet cover set.
There will be two home visits to the control group. During the first home visit, a
heat-humidity meter device will be given. Data collection forms will be applied at the
beginning and end of the study.training will be organized at the end of the study.
