Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT06823869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Distraction Methods on Children Aged 3-6 Years Receiving Inhaler Therapy
Sponsor:
Ondokuz Mayıs University
Organization:
Study Overview
Official Title:
The Effect of Distraction Methods on Children Aged 3-6 Years Receiving Inhaler Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to observe the effect of distraction methods on children aged 3-6 years who apply to the emergency department due to respiratory complaints and receive inhaler medication.
Detailed Description:
The research was designed based on voluntary participation in threegroups: the experimental group (doll and musical keyboard or musical book) and the control group. The inhaler drug application process is planned to be 10 minutes.
First, routine explanations are given to the children in the experimental group, and the child is ensured to be in an upright position for the parent to be present and to administer the inhaler medication. The child is explained that a doll will accompany him during the inhaler medication administration, and a nebulization mask is attached to the doll. Before starting the inhaler medication administration, the doll is placed next to the child in a sitting position. The child is asked to sit with the doll for 5 minutes and the child is asked whether he/she will play with a musical book or a musical piano.After the child decides which toy he/she will play with and plays with the toy for 5 minutes, the Child Fear Scale (CCS) and the Children's Emotional Indicators Scale (ÇEGÖ) are evaluated by the child, parent, researcher, nurse and vital signs before starting the procedure. Later, when the researcher decides that the child is ready for the procedure, inhaler medication administration is started. After the drug administration is completed, the child, parent, researcher and nurse evaluate the CQS and CEGRS, and vital signs are evaluated by the researcher, and the parent gives a parental satisfaction score.
In the control group, a routine explanation of the emergency department is given to the child and the parent, the parent is next to the child and the child is ensured to sit upright during the inhaler medication administration. To the children in the control group, the researcher shows how the procedure will be done with a nebula mask on himself. The procedure begins after the necessary explanations are made and the researcher decides that the child is ready for inhaler medication administration. Before starting the procedure, the child, parent, researcher, nurse and vital signs are evaluated by the researcher. After the inhaler intake is completed, ÇÖS and ÇEGÖ child, researcher, nurse, parent; Vital signs are evaluated by the researcher and parental satisfaction score is given by the parent.
First, routine explanations are given to the children in the experimental group, and the child is ensured to be in an upright position for the parent to be present and to administer the inhaler medication. The child is explained that a doll will accompany him during the inhaler medication administration, and a nebulization mask is attached to the doll. Before starting the inhaler medication administration, the doll is placed next to the child in a sitting position. The child is asked to sit with the doll for 5 minutes and the child is asked whether he/she will play with a musical book or a musical piano.After the child decides which toy he/she will play with and plays with the toy for 5 minutes, the Child Fear Scale (CCS) and the Children's Emotional Indicators Scale (ÇEGÖ) are evaluated by the child, parent, researcher, nurse and vital signs before starting the procedure. Later, when the researcher decides that the child is ready for the procedure, inhaler medication administration is started. After the drug administration is completed, the child, parent, researcher and nurse evaluate the CQS and CEGRS, and vital signs are evaluated by the researcher, and the parent gives a parental satisfaction score.
In the control group, a routine explanation of the emergency department is given to the child and the parent, the parent is next to the child and the child is ensured to sit upright during the inhaler medication administration. To the children in the control group, the researcher shows how the procedure will be done with a nebula mask on himself. The procedure begins after the necessary explanations are made and the researcher decides that the child is ready for inhaler medication administration. Before starting the procedure, the child, parent, researcher, nurse and vital signs are evaluated by the researcher. After the inhaler intake is completed, ÇÖS and ÇEGÖ child, researcher, nurse, parent; Vital signs are evaluated by the researcher and parental satisfaction score is given by the parent.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: