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Effect of Home Environment Regulation on Symptom Control and Quality of Life in Children With Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
nursing intervention
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Allergic Rhinitis focused on measuring allergic rhinitis, children, nursing, Allergic Rhinitis Due to House Dust Mite

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Necmettin Erbakan Universty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality of Life Questionnaire for 6-12 Years Old Children with Allergy in the Nose and Eyes (pediatric rinitis quality of life questionnaire PRQLQ)
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.

Secondary Outcome Measures

home environment regulation
The average score will be taken using the home environment evaluation form.this form was created by researchers.
symptom monitoring
The form created by the researchers aims to identify the symptoms of allergic rhinitis.forms are scored between 0-10.

Full Information

First Posted
July 6, 2020
Last Updated
April 6, 2022
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT04479085
Brief Title
Effect of Home Environment Regulation on Symptom Control and Quality of Life in Children With Allergic Rhinitis
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
November 25, 2020 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
allergic rhinitis, children, nursing, Allergic Rhinitis Due to House Dust Mite

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pretest-posttest, parallel group, randomized controlled study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
nursing intervention
Intervention Description
It includes individual trainings for the regulation of the home environment, give a booklet to reinforce education and to give anti-allergic bedding sets.
Primary Outcome Measure Information:
Title
Quality of Life Questionnaire for 6-12 Years Old Children with Allergy in the Nose and Eyes (pediatric rinitis quality of life questionnaire PRQLQ)
Description
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.
Time Frame
It will be monitored at the beginning and end of the study.
Secondary Outcome Measure Information:
Title
home environment regulation
Description
The average score will be taken using the home environment evaluation form.this form was created by researchers.
Time Frame
It will be monitored at the beginning and end of the study.
Title
symptom monitoring
Description
The form created by the researchers aims to identify the symptoms of allergic rhinitis.forms are scored between 0-10.
Time Frame
It will be monitored every week for 17 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muradiye ALDEM BUDAK
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emine GEÇKİL
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Study Director
Facility Information:
Facility Name
Necmettin Erbakan Universty
City
Konya
ZIP/Postal Code
42050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Home Environment Regulation on Symptom Control and Quality of Life in Children With Allergic Rhinitis

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