<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04479085</url>
  </required_header>
  <id_info>
    <org_study_id>maldem</org_study_id>
    <nct_id>NCT04479085</nct_id>
  </id_info>
  <brief_title>Effect of Home Environment Regulation on Symptom Control and Quality of Life in Children With Allergic Rhinitis</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Necmettin Erbakan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Necmettin Erbakan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the effect of nursing intervention to regulate the&#xD;
      home environment on symptom control and quality of life in children with allergic rhinitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Allergic rhinitis (AR) is a clinical picture resulting from one or more allergen&#xD;
      sensitivities. Seasonal AR develops due to grass, tree and grass pollen. Prennial AR develops&#xD;
      due to house dust mite, cockroaches, mold and pets.The prevalence of allergic rhinitis in&#xD;
      children ranges from 19.3-50.8%. AR affects school performance, sleep patterns and quality of&#xD;
      life in children.Children spend most of their lives in the home environment, and many studies&#xD;
      have shown that AR is associated with the home environment in children. Control measures&#xD;
      should be taken in patients' homes to prevent and reduce the symptoms of allergic rhinitis in&#xD;
      children. Awareness and education should be provided to families and children about the&#xD;
      importance of these measures.&#xD;
&#xD;
      This study is a pretest-posttest, parelel group, randomized controlled study study to examine&#xD;
      the effect of nursing intervention to regulate the home environment on symptom control and&#xD;
      quality of life in children with allergic rhinitis.&#xD;
&#xD;
      sample of the study; The effect size was intended to be medium effect size due to the absence&#xD;
      of a similar randomized controlled study to determine the quality of life in children with&#xD;
      allergic rhinitis. In the study, the number of samples to be included in the study with 0.7&#xD;
      medium effect size, power 80%, alpha reliability level 95%, 26 experiments and 26 controls&#xD;
      were calculated as 52 children and their mothers.&#xD;
&#xD;
      Randomized appointments were made in the appointment of 52 children and mothers who were&#xD;
      followed up with the diagnosis of allergic rhinitis, who included the criteria for inclusion&#xD;
      and exclusion, and who volunteered to participate in the study. Stratified randomization&#xD;
      method was used in this study. Stratified randomization method was used in this study. The&#xD;
      gender of the children (girls and boys), the age of the children (6-9 years, 10-12 years) and&#xD;
      the level of mother education (primary education, high school, university) were determined as&#xD;
      prognastic factors for stratification. Randomization was performed in a total of 52&#xD;
      participants, 26 experimental and 26 control groups.&#xD;
&#xD;
      Number, percentage, average and standard deviation will be used in the evaluation of the&#xD;
      descriptive data obtained from the research; Significance will be evaluated within 95%&#xD;
      confidence interval, p &lt;0.05 will be taken.&#xD;
&#xD;
      The nursing attempt to organize the home environment for the experimental group will take 17&#xD;
      weeks. During this period, two home visits and two telephone calls will be made. During the&#xD;
      first home visit, training will be organized to regulate the home environment, as well as a&#xD;
      heat-moisture meter and anti-allergic duvet cover set.&#xD;
&#xD;
      There will be two home visits to the control group. During the first home visit, a&#xD;
      heat-humidity meter device will be given. Data collection forms will be applied at the&#xD;
      beginning and end of the study.training will be organized at the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>pretest-posttest, parallel group, randomized controlled study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life Questionnaire for 6-12 Years Old Children with Allergy in the Nose and Eyes (pediatric rinitis quality of life questionnaire PRQLQ)</measure>
    <time_frame>It will be monitored at the beginning and end of the study.</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>home environment regulation</measure>
    <time_frame>It will be monitored at the beginning and end of the study.</time_frame>
    <description>The average score will be taken using the home environment evaluation form.this form was created by researchers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptom monitoring</measure>
    <time_frame>It will be monitored every week for 17 weeks.</time_frame>
    <description>The form created by the researchers aims to identify the symptoms of allergic rhinitis.forms are scored between 0-10.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>nursing intervention</intervention_name>
    <description>It includes individual trainings for the regulation of the home environment,&#xD;
give a booklet&#xD;
to reinforce education and to give anti-allergic bedding sets.</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The child is diagnosed with allergic rhinitis&#xD;
&#xD;
          -  6-12 age group children&#xD;
&#xD;
          -  The child's sensitivity to at least one of Dermatophagoides pteronyssinus and/or&#xD;
             Dermatophagoides farinae according to the skin prick test.&#xD;
&#xD;
          -  Although sensitive to at least one of the house dust mites Dermatophagoides&#xD;
             pteronyssinus and/or Dermatophagoides farinae according to the child's skin pric test;&#xD;
&#xD;
               -  The child has mold allergy according to the skin prick test&#xD;
&#xD;
               -  The child is allergic to cockroaches according to the skin prick test&#xD;
&#xD;
               -  The child has any of the cat and dog allergies according to the skin prick test&#xD;
&#xD;
          -  Volunteering to participate in the research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The child has an additional chronic disease other than allergic rhinitis&#xD;
&#xD;
          -  Pol The child is allergic to pollen according to the skin prick test&#xD;
&#xD;
          -  Child and mother are not literate in Turkish Communication barriers in children and&#xD;
             mothers (seeing, hearing, diagnosed mental and mental problems)&#xD;
&#xD;
          -  Lack of up-to-date family phone information&#xD;
&#xD;
          -  Child and mother living outside the city center&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muradiye ALDEM BUDAK</last_name>
    <role>Principal Investigator</role>
    <affiliation>Necmettin Erbakan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emine GEÇKİL</last_name>
    <role>Study Director</role>
    <affiliation>Necmettin Erbakan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Necmettin Erbakan Universty</name>
      <address>
        <city>Konya</city>
        <zip>42050</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Necmettin Erbakan University</investigator_affiliation>
    <investigator_full_name>muradiye aldem budak</investigator_full_name>
    <investigator_title>research assistant</investigator_title>
  </responsible_party>
  <keyword>allergic rhinitis</keyword>
  <keyword>children</keyword>
  <keyword>nursing</keyword>
  <keyword>Allergic Rhinitis Due to House Dust Mite</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04479085
org study id: maldem
nct id: NCT04479085
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: pretest-posttest, parallel group, randomized controlled study
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: 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.
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.
measure: home environment regulation
time frame: It will be monitored at the beginning and end of the study.
description: The average score will be taken using the home environment evaluation form.this form was created by researchers.
measure: symptom monitoring
time frame: It will be monitored every week for 17 weeks.
description: The form created by the researchers aims to identify the symptoms of allergic rhinitis.forms are scored between 0-10.
arm group label: experimental group
arm group type: Experimental
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 group label: control group
arm group type: No Intervention
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: nursing 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.
arm group label: experimental group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Muradiye ALDEM BUDAK
role: Principal Investigator
affiliation: Necmettin Erbakan University
last name: Emine GEÇKİL
role: Study Director
affiliation: Necmettin Erbakan University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Necmettin Erbakan University
investigator full name: muradiye aldem budak
investigator title: research assistant
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
sharing ipd: No