Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486610
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-03
Brief Title:
Effect of Inhalation Therapy on Childrens Fear and Anxiety Levels and Physiological Parameters
Sponsor:
Recep Tayyip Erdogan University
Organization:
Recep Tayyip Erdogan University
Study Overview
Official Title:
Inhalation With Toy Figure and Sound Insulated Nebulizer Effect of Treatment on Childrens Fear and Anxiety Levels and Physiological Parameters Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
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 research was planned as a randomized controlled study Between July 2023 and July 2025 he was hospitalized in the pediatric emergency department of Recep Tayyip Erdogan University Training and Research Hospital and was treated with a nebulizer It includes children aged 3-6 and their mothers receiving treatment The sample of the research will consist of 120 children and their mothers who applied to the pediatric emergency department between the specified dates and met the inclusion criteria and volunteered to participate in the research Introductory Information Form Child Fear Scale Emotional Indicators Scale in Children Physiological Parameter Tracking Form will be used to collect data Nebulizer with Toy Figure Sound Insulated Silent Nebulizer and Toy with Fish Figure will be used as research materials
Detailed Description:
The research was planned as a randomized controlled study Between July 2023 and July 2025 he was hospitalized in the pediatric emergency department of Recep Tayyip Erdogan University Training and Research Hospital and was treated with a nebulizer It includes children aged 3-6 and their mothers receiving treatment The sample of the research will consist of 120 children and their mothers who applied to the pediatric emergency department between the specified dates and met the inclusion criteria and volunteered to participate in the research Introductory Information Form Child Fear Scale Emotional Indicators Scale in Children Physiological Parameter Tracking Form will be used to collect data Nebulizer with Toy Figure Sound Insulated Silent Nebulizer and Toy with Fish Figure will be used as research materials
Data Collection
Data for the study will be obtained through face-to-face interviews Initially children in the groups using either a toy-figured nebulizer or a Sound-Insulated Silent Nebulizer will complete an Introductory Information Form The physiological parameters of the children will be measured by an experienced nurse in pediatric emergency care 15 minutes before during the 10th minute of and 15 minutes after the nebulizer medication application and recorded on a Physiological Parameters Form Additionally the Child Fear Scale and the Emotional Indicators in Children Scale will be administered 15 minutes before during the 10th minute of and 15 minutes after the medication application with the toy-figured nebulizer For the control group routine inhalation therapy of the service will be applied without any additional intervention Children in this group will also fill out the Introductory Information Form Their life signs will be measured similarly by the experienced nurse and recorded on a Physical Parameters Form The Child Fear Scale and Emotional Indicators in Children Scale will be administered during the 10th minute and 15 minutes after the routine medication application Due to the nature of the study blinding during the execution will not be possible however to prevent potential bias measurements will be taken by both the experienced nurse for physiological parameters Child Fear Scale Emotional Indicators in Children Scale and parents for Child Fear Scale Emotional Indicators in Children Scale Statistical analysis and reporting will be conducted without knowledge of which group is the experimental or control group coding will be applied
Data Evaluation
Data processing and statistical analyses will be performed using Statistical Package for the Social Sciences for Windows 200 For measurements not conforming to a normal distribution non-parametric methods will be utilized The Kruskal-Wallis H test χ2-table value will be used for comparing three or more independent groups Pearson-χ2 cross-tabulations will be employed to examine the relationships between two qualitative variables The Spearman correlation coefficient will be used to analyze the relationships between two quantitative variables that do not follow a normal distribution
Ethical Principles of the Research
For the execution of the study official permission has been obtained from the Ethical Committee of the Recep Tayyip Erdogan University Faculty of Medicine Children eligible for the research group along with their parents will be informed about the purpose of the study and their questions will be answered before obtaining their verbal and written consent Parents and children will be assured that the data collected during the research will be processed anonymously and confidentially will not be used outside of this study and they may withdraw from the study at any time
Data Collection
Data for the study will be obtained through face-to-face interviews Initially children in the groups using either a toy-figured nebulizer or a Sound-Insulated Silent Nebulizer will complete an Introductory Information Form The physiological parameters of the children will be measured by an experienced nurse in pediatric emergency care 15 minutes before during the 10th minute of and 15 minutes after the nebulizer medication application and recorded on a Physiological Parameters Form Additionally the Child Fear Scale and the Emotional Indicators in Children Scale will be administered 15 minutes before during the 10th minute of and 15 minutes after the medication application with the toy-figured nebulizer For the control group routine inhalation therapy of the service will be applied without any additional intervention Children in this group will also fill out the Introductory Information Form Their life signs will be measured similarly by the experienced nurse and recorded on a Physical Parameters Form The Child Fear Scale and Emotional Indicators in Children Scale will be administered during the 10th minute and 15 minutes after the routine medication application Due to the nature of the study blinding during the execution will not be possible however to prevent potential bias measurements will be taken by both the experienced nurse for physiological parameters Child Fear Scale Emotional Indicators in Children Scale and parents for Child Fear Scale Emotional Indicators in Children Scale Statistical analysis and reporting will be conducted without knowledge of which group is the experimental or control group coding will be applied
Data Evaluation
Data processing and statistical analyses will be performed using Statistical Package for the Social Sciences for Windows 200 For measurements not conforming to a normal distribution non-parametric methods will be utilized The Kruskal-Wallis H test χ2-table value will be used for comparing three or more independent groups Pearson-χ2 cross-tabulations will be employed to examine the relationships between two qualitative variables The Spearman correlation coefficient will be used to analyze the relationships between two quantitative variables that do not follow a normal distribution
Ethical Principles of the Research
For the execution of the study official permission has been obtained from the Ethical Committee of the Recep Tayyip Erdogan University Faculty of Medicine Children eligible for the research group along with their parents will be informed about the purpose of the study and their questions will be answered before obtaining their verbal and written consent Parents and children will be assured that the data collected during the research will be processed anonymously and confidentially will not be used outside of this study and they may withdraw from the study at any time
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None