The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety on Children

November 19, 2024 updated by: Atiye Karakul, Tarsus University

The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety of 4-6-year-old Children Who Are Administered Inhaler Medication.

This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on children's fear and physiological parameters in 3-6 year old children who were administered inhaler medication. The population of the study, planned as a randomized controlled experimental study, will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment. According to the power analysis performed for the sample size, the power of the sample was calculated with the G*Power 3.1 program, in line with the literature (Durak 2019; Özsamuri 2020). While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. Child Information Form, Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on children's fear and physiological parameters in 3-6 year old children who were administered inhaler medication. The population of the study, planned as a randomized controlled experimental study, will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment. According to the power analysis performed for the sample size, the power of the sample was calculated with the G*Power 3.1 program, in line with the literature. While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. Child Information Form, Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data.

Data collection In the study, children treated in pediatric emergency departments and administered inhaler medication will first be evaluated in terms of sampling criteria, and children who do not meet the criteria will be excluded from the study. The nurse researcher is the one who collects the data, evaluates it with the Fear and Anxiety Scale, and evaluates the physiological parameters.

Data analyses The data obtained in the study were analyzed using the Statistical Package for Social Sciences for Windows 25.0 program. Descriptive statistical methods (number, percentage, min-max values, mean and standard deviation) will be used when evaluating the data. The suitability of the data used to normal distribution will be checked with kurtosis and skewness values. In normally distributed data, when comparing quantitative data, an independent t-test will be used for the difference between two independent groups, and when comparing more than two dependent groups, analysis of variance will be applied in repeated measurements, and in case of a difference, Bonferroni will be used to find the group that makes the difference. In comparing quantitative data with non-normally distributed data, the Mann-Whitney U test will be applied for the difference between two independent groups, and in comparing more than two dependent groups, the Friedman test will be applied, and in case of a difference, the corrected Bonferroni will be used to find the group that makes the difference. Chi-square analysis will be applied to test the relationship between categorical variables. Cohen's Kappa Test will be applied in interobserver agreement analysis.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mersin, Turkey
        • Tarsus State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The child is between 4 and 6 years old,
  • No communication problems (visual/auditory/mental),
  • Oxygen saturation is 90% or above,
  • The child does not have a disease that may affect his/her life,
  • Parent and child volunteering to participate in the research.

Exclusion Criteria:

  • Nebul drug administration
  • The child has visual, hearing, and mental disabilities,
  • Having taken medication with a nebulizer before

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Playing with toy nebulizer
The child who needs to take inhaler medication is taken to the observation room. Before starting the procedure, the child will be introduced to the toy nebulizer. The toy nebulizer is shown to the child as an example and allowed to play with it so that the level of fear can be reduced.
Other: Playing with toy nebulizer
The child who needs to take inhaler medication is taken to the observation room. Before starting the procedure, the toy nebulizer is introduced to the child. The toy nebulizer is shown to the child as an example and allowed to play, thus reducing the level of fear. Inhaler medication is given through a mask for 10 minutes. Vital signs (pulse) before and after the application. , blood pressure, SPo2, respiration), the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.
Experimental: Cartoon
Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. 2-3 minutes before starting drug treatment, the child will be allowed to watch cartoons according to his age group and will be encouraged to do so throughout the procedure. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application of the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.
Other: Cartoon

Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. 2-3 minutes before starting drug treatment, the child will be allowed to watch cartoons according to his age group and will be encouraged to do so throughout the procedure.

Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.
No Intervention: Control
Routine care will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fear
Time Frame: 1 day
Child Fear Scale is used to evaluate the anxiety/fear level of children. The scale uses cartoon faces consisting of five pictures and the anxiety/fear level is evaluated with numbers between "0" and "4". The first picture shows a score of "0", that is, "no anxiety/fear is felt", and the last picture shows a score of "4", that is, "the most severe anxiety/fear". As the score increases, the level of anxiety/fear also increases.
1 day
anxiety
Time Frame: 1 day
Child Anxiety Scale-The State scale resembles a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. This scale, for children ages 4 to 10, asks children, "Imagine that all your anxious or nervous emotions are in the bulb or bottom part of the thermometer," or "If you are a little anxious or nervous, the emotions might move up a little bit on the thermometer." If you're very, very anxious or nervous, emotions can run rampant. "Put a line on the thermometer that shows how anxious or angry you are." To measure state anxiety, the child is asked to indicate what he or she is feeling "right now." The score can vary between 0-10.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

November 19, 2024

Study Completion (Actual)

November 19, 2024

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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