Clinical trial NCT05881941: The Effect of Sound-Insulated Music Playing and Fıgured Mask Nebulızer Application on the Processing Anxiety of Children
Official title: The Effect of Sound-Insulated Music Playing and Fıgured Mask Nebulızer Application on the Processing Anxiety of Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Child, Only
Keywords: mask
Child
Anxiety
Nebulizer
Atraumatic Care
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: . There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this is a randomized controlled intervention study. The study was carried out to determine the effect of nebulization treatment applied to 3-6-year-old children with a soundproof, music player and figured mask nebulizer on the child's anxiety during the procedure. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine.

Detailed description: This is a randomized controlled intervention study. The research was carried out in Kütahya Health Sciences University Evliya Çelebi Training and Research Hospital Paediatrics Emergency Service between 1st May 2022 and 1st June 2022. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine. In order to collect data, Descriptive Information Form, State Trait Anxiety Inventory for Parents, Child Fear Scale and Child Emotional Indicators Scale were used. The data obtained in the study were evaluated with the IBM SPSS Statistics 24 (Statistical Package for Social Sciences) package program.

Eligibility criteria: Inclusion Criteria:

* the child should be between the ages of 3-6,
* will receive inhaler treatment,
* the mother or father should be with the child during the procedure,
* not have used any sedative drugs in the last 8 hours before the application,
* written consent has been obtained from the parents after the procedure,
* the child is not crying before the start

Exclusion Criteria:

* the child is younger than 3 years old, older than 6 years oldu,
* the childe has a mental disability,
* communication with the parent havinh a problem (they cannot understand and speak Turkish, etc.),
* the child has pain,
* the child is the terminal period,
* the parent has a situation that prevents the assessment of the scale (mental disability, etc.)

Primary outcomes:
measure: The Wong-Baker Faces Pain Scale
timeFrame: pre-processing
measure: The Children's Emotional Indicators Scale (CIAS)
timeFrame: order of operation
measure: The Child Fear Scale (CFS)
timeFrame: order of operation
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Osmangazi University
state: Centre
Study officials:
affiliation: aacikgoz@ogu.edu.tr
name: Ayfer Açıkgöz
role: PRINCIPAL_INVESTIGATOR
References: