Effect of Cartoon and Storytelling on the Children's Fear and Anxiety Levels During Inhalation Therapy With Nebulizer in Emergency Department

June 11, 2025 updated by: Sibel Serap Ceylan, Pamukkale University
Inhalation therapy with a nebulizer is a non-invasive and easy-to-use technology. However, the use of masks and the loud, unpleasant sound of the nebulizer can cause fear and anxiety in children. For nebulizer inhalation therapy to be effective, it is important to reduce children's fear and anxiety and to increase their compliance with treatment. Simple and inexpensive distraction methods can be used to achieve this. The results show that cartoon and storytelling methods reduce fear and anxiety in children undergoing inhalation therapy with the nebulizer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aimed to evaluate the impact of cartoons and storytelling during nebulizer inhalation treatment on procedure-related fear and anxiety in children. This randomized controlled study employed a 3-arm parallel design with 99 children aged 5-8 receiving nebulizer therapy in the pediatric emergency department. Groups 1 and 2 served as the experimental groups, while Group 3 acted as the control group, with no intervention addressing fear and anxiety. Group 1 utilized storytelling as a distraction, while Group 2 watched cartoons. Data were collected using the Descriptive Characteristics Form, the Child Follow-Up Form, the Children's Anxiety Meter-State, and the Child Fear Scale.

In the study, parental presence was ensured during the procedure in all groups. For this reason, parents were informed, and their questions about inhalation treatment with nebulizers were answered before data collection to reduce parents' stress and anxiety in all groups and to prevent children from being affected by their parents' emotional situation. The parents were seated in a comfortable chair beside the children's bed.

Before the inhalation treatment with a nebulizer, the procedure was explained to the child according to the child's developmental level, the fear and anxiety levels of the children were evaluated, and their cardiorespiratory rates were measured. Then, inhalation therapy with a nebulizer was started. During the procedure, children's anxiety levels, crying situations, and cardiorespiratory rates were measured. After the procedure, the nebulizer was turned off, the mask was removed, and their faces were cleaned. The children's fear and anxiety levels were evaluated for the last time, and their cardiorespiratory rates were measured. The duration of the inhalation treatment was approximately 15 minutes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Pamukkale
      • Denizli, Pamukkale, Turkey, 20000
        • Sibel Serap Ceylan

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Children between 5 and 8 years old, who received inhalation therapy with a nebulizer for the first time, had no communication problems, and gave consent were included in the study.

Exclusion Criteria:

Children who had vision, hearing, and comprehension problems, mental and neurological diseases, life-threatening diseases, those who used any medication with sedative effects, or those who refused interventions during nebule treatment were not included in the study.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
To reduce fear and anxiety in the children in this group, the storytelling method was used by the parents during the nebulizer treatments.
Other: storytelling
to distract telling a story
Experimental: Group 2
During nebulizer treatments, children in this group collaboratively chose cartoons on YouTube with their parents and watched them on phones using the hospital's internet.
Other: cartoon
to distract watching a cartoon
No Intervention: Group 3
No intervention was performed on the children in the control group to reduce fear and anxiety related to inhalation therapy with a nebulizer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
fear level
Time Frame: 15-30 minute
The Child Fear Scale (CFS) was used children's fear level
15-30 minute
anxiety level
Time Frame: 15-30 minute
To determite anxiety level of children The Children's Anxiety Meter-State (CAM-S) was used.
15-30 minute
crying duration
Time Frame: 15-30 minute
The crying duration of the children during the procedure was measured and recorded by the researchers with a stopwatch.
15-30 minute
Cardiorespiratory rates:
Time Frame: 15-30 minute
Children's respiration rate was measured by observation, pulse rate and SPO2 levels were measured by finger pulse oximeter.
15-30 minute

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PamU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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