NCT04479085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

July 6, 2020

Last Update Submit

April 6, 2022

Conditions

Keywords

allergic rhinitischildrennursingAllergic Rhinitis Due to House Dust Mite

Outcome Measures

Primary Outcomes (1)

  • 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.

    It will be monitored at the beginning and end of the study.

Secondary Outcomes (2)

  • home environment regulation

    It will be monitored at the beginning and end of the study.

  • symptom monitoring

    It will be monitored every week for 17 weeks.

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Other: nursing intervention

control group

NO INTERVENTION

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.

Interventions

It includes individual trainings for the regulation of the home environment, give a booklet to reinforce education and to give anti-allergic bedding sets.

experimental group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The child is diagnosed with allergic rhinitis
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan Universty

Konya, 42050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Methods

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Muradiye ALDEM BUDAK

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR
  • Emine GEÇKİL

    Necmettin Erbakan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pretest-posttest, parallel group, randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 21, 2020

Study Start

July 1, 2020

Primary Completion

November 25, 2020

Study Completion

September 30, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations