- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479085
Effect of Home Environment Regulation on Symptom Control and Quality of Life in Children With Allergic Rhinitis
The Effect of Nursing Initiative for Home Environment Regulation on Symptom Control and Quality of Life in Children With Allergic Rhinitis: A Randomized Controlled Study
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Konya, Turkey, 42050
- Necmettin Erbakan Universty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The child is diagnosed with allergic rhinitis
- 6-12 age group children
- The child's sensitivity to at least one of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae according to the skin prick test.
Although sensitive to at least one of the house dust mites Dermatophagoides pteronyssinus and/or Dermatophagoides farinae according to the child's skin pric test;
- The child has mold allergy according to the skin prick test
- The child is allergic to cockroaches according to the skin prick test
- The child has any of the cat and dog allergies according to the skin prick test
- Volunteering to participate in the research
Exclusion Criteria:
- The child has an additional chronic disease other than allergic rhinitis
- Pol The child is allergic to pollen according to the skin prick test
- Child and mother are not literate in Turkish Communication barriers in children and mothers (seeing, hearing, diagnosed mental and mental problems)
- Lack of up-to-date family phone information
- Child and mother living outside the city center
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: experimental group
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.
Temperature and humidity changes of the houses will be monitored during the operation with the heat-moisture meter device.
Children in this group will be given an anti-allergic duvet cover.
Home environment arrangements of mothers and changes in the quality of life of children will be examined at the beginning and end of the study.
Children's symptoms will be monitored weekly for 17 weeks.
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It includes individual trainings for the regulation of the home environment, give a booklet to reinforce education and to give anti-allergic bedding sets. |
No Intervention: control group
No intervention will be made on the control group.
The humidity and temperature changes in the home environment of the children in this group and their symptoms will be monitored on a weekly basis during the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life Questionnaire for 6-12 Years Old Children with Allergy in the Nose and Eyes (pediatric rinitis quality of life questionnaire PRQLQ)
Time Frame: It will be monitored at the beginning and end of the study.
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Average quality of life score of children will be taken by using the Quality of Life Survey for 6-12 Years Old Children with Allergy in their Nose and Eyes.
The scale includes scoring between 0-6 High average score indicates low quality of life.
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It will be monitored at the beginning and end of the study.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
home environment regulation
Time Frame: It will be monitored at the beginning and end of the study.
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The average score will be taken using the home environment evaluation form.this
form was created by researchers.
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It will be monitored at the beginning and end of the study.
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symptom monitoring
Time Frame: It will be monitored every week for 17 weeks.
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The form created by the researchers aims to identify the symptoms of allergic rhinitis.forms
are scored between 0-10.
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It will be monitored every week for 17 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muradiye ALDEM BUDAK, Necmettin Erbakan University
- Study Director: Emine GEÇKİL, Necmettin Erbakan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- maldem
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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