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

NCT ID: NCT04479085

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergic Rhinitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

pretest-posttest, parallel group, randomized controlled study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

nursing intervention

Intervention Type OTHER

It includes individual trainings for the regulation of the home environment,

give a booklet

to reinforce education and to give anti-allergic bedding sets.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nursing intervention

It includes individual trainings for the regulation of the home environment,

give a booklet

to reinforce education and to give anti-allergic bedding sets.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

muradiye aldem budak

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Muradiye ALDEM BUDAK

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

Emine GEÇKİL

Role: STUDY_DIRECTOR

Necmettin Erbakan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Necmettin Erbakan Universty

Konya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

maldem

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nasya in Allergic Rhinitis
NCT01503957 COMPLETED PHASE3
Theophylline in Rhinitis
NCT01132781 COMPLETED PHASE2