Effects of Cartoons & Interactive Storytelling on Fear and Comfort in 6-9 Year Olds During Nebulizer Treatment

April 2, 2026 updated by: Ozlem Guzel Polat, Mersin University

The Effect of Cartoon Viewing and Breath-Synchronized Interactive Storytelling During Nebulizer Medication Administration on Fear, Emotional Behavior, and Comfort in 6-9 Year Old Children: A Randomized Controlled Study

Fear and anxiety experienced by children during inhalation therapy (using a nebulizer or vaporizer) are key factors that make treatment compliance difficult and reduce the quality of care. Young children, in particular, may perceive this process as "threatening" due to mask use, the noise produced by the device, and a sense of loss of control. This situation triggers a significant physiological stress response in the child.

Therefore, in pediatric nursing, non-pharmacological methods that increase children's participation in treatment are of great importance. The literature indicates that interventions such as showing cartoons, playing music, and using distracting visual materials both reduce anxiety and improve stress indicators like heart rate. Additionally, therapeutic play has been proven to help children adapt to the hospital environment and soothe their emotional reactions.

This study aims to evaluate the effectiveness of a nursing intervention-designed to enhance children's physical comfort and manage their fear and anxiety during inhalation therapy-that is breath-synchronized, interactive, and story-based.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Implementation: In this study, which will be conducted on children aged 6-9 years who meet the inclusion criteria, groups will be formed using a computer-assisted randomization method. Before inclusion, the purpose of the study, the procedures to be performed, and the possible benefits and risks will be explained to the parents in understandable language, and written informed consent will be obtained from the parents. The child will receive an explanation appropriate to their developmental level before the procedure. If the children do not wish to participate in the procedure, a coercive approach will not be applied, and their standard treatments will continue uninterrupted.

In the study, children will be randomly assigned to three groups: the cartoon viewing group, the breath-synchronized interactive storytelling group, and the standard care group. Pre-test forms will be administered before the study.

Cartoon Group (CG): During nebulizer administration, children aged 6-9 years will be shown a short, calm-paced cartoon appropriate for them and free of fear or violence. The cartoon will be shown using an iPad mini with internet access.

Breath-Synchronized Interactive Storytelling Group (SWB-ISG): In this group, children will receive an intervention based on breath-synchronized, interactive storytelling during nebulizer medication administration. Storytelling will be conducted by a nurse with more than five years of experience in the pediatric ward and a science degree, using a pre-prepared standard text with the same content and verbal patterns for all participants. During storytelling, the child's breathing will be synchronized with their breathing through verbal guidance. The inhalation time will be approximately 3 seconds, and the exhalation time will be approximately 4 seconds. The child's attention will be supported on a multisensory level during storytelling.

Standard Care Group (SC): In this group, nebulizer medication administration will be performed according to the clinic's routine practices and in the presence of the child's mother. Prior to the procedure, a brief, age-appropriate explanation of how the nebulizer works will be given to the parent and child, but no distracting additional interventions will be used. Nebulizer administration will be completed with the child in a seated position, using a standard mask, and for the duration specified in the clinical protocol.

Final test forms will be administered immediately after and 2 minutes after the completion of medication administration. (Child Information Form; Child Fear Scale; and Children's Emotional Indicators Scale).

Research Hypotheses:

H1a: There is a statistically significant difference in the mean fear scores of children during inhalation therapy among the three groups (cartoon group: CG, breath-synchronized interactive story group: SWB-ISG, Standard Group: SG).

H1b: There is a statistically significant difference in the mean comfort scores of children during inhalation therapy among the three groups (CG, SWB-ISG, SG).

H1c: There is a statistically significant difference in the emotional behavior of children during inhalation therapy among the three groups (CG, SWB-ISG, SG).

Statistical Analysis

The collected data will be analyzed using statistical software programs:

Normality Test: The distribution of the data (skewness and kurtosis) will be examined to select the appropriate test method (parametric or non-parametric).

Comparison of Groups: The demographic and clinical characteristics of the groups will be compared to determine whether they are similar.

Effect Size: Cohen's d coefficient will be calculated to determine the strength of the difference between the groups.

Study Type

Interventional

Enrollment (Estimated)

96

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 Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Mersin, Turkey (Türkiye), 33100
        • Mersin University
        • Contact:
        • Principal Investigator:
          • Özlem Güzel Polat
        • Principal Investigator:
          • Derya Akdeniz Uysal
        • Sub-Investigator:
          • Güzide Üğücü
        • Sub-Investigator:
          • Merve Kurt
        • Sub-Investigator:
          • Atiye Karakul
        • Sub-Investigator:
          • Duygu Sönmez Düzkaya

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:

  • - Children aged 6-9 years
  • Scheduled to receive nebulizer inhalation therapy due to acute or chronic respiratory disease
  • Conscious, responsive to environmental stimuli, and able to communicate verbally or nonverbally
  • Without a diagnosed neurodevelopmental disorder (severe autism spectrum disorder, severe intellectual disability, etc.)
  • Without severe hearing or vision loss that would impair storytelling and visual material comprehension
  • Without signs of respiratory failure requiring emergency intervention during nebulizer administration
  • With written informed consent from a parent or legal guardian
  • Children who are willing to participate in the study after being given explanations appropriate to their age and developmental level.

Exclusion Criteria:

  • Patients who require emergency medical intervention during nebulizer application, such as severe respiratory distress, cyanosis, or significantly low oxygen saturation.
  • Patients who are unconscious or unable to respond adequately to environmental stimuli.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cartoon group: CG
During nebulizer administration, children aged 6-9 years will be shown a short, calm-paced cartoon that is appropriate for them and does not contain fear or violence. The cartoon will be shown using an iPad mini with internet access.
Behavioral: Cartoon Watching
Active Distraction Methods
Experimental: Breath-Synchronized Interactive Storytelling Group (SWB-ISG)
In this group, children will receive an intervention based on breath-synchronized, interactive storytelling during nebulizer medication administration. Storytelling will be conducted by a nurse with more than five years of experience in the pediatric ward and a science degree, using a pre-prepared standard text with the same content and verbal patterns for all participants. During storytelling, the child's breathing will be synchronized with their breathing through verbal guidance. The inhalation time will be approximately 3 seconds, and the exhalation time will be approximately 4 seconds. The child's attention will be supported on a multisensory level during storytelling.
Behavioral: Interactive storytelling synchronized with breath
Active Distarction Methods
Experimental: Standard Care Group (SG)
In this group, nebulizer medication administration will be performed according to the clinic's routine practices and in the presence of the child's mother. Prior to the procedure, a brief, age-appropriate explanation of how the nebulizer works will be given to the parent and child, but no distracting additional interventions will be used. Nebulizer administration will be completed with the child in a seated position, using a standard mask, and for the duration specified in the clinical protocol.
Behavioral: Standard Group
Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the mean score of children in Children's Fear Scale
Time Frame: During the procedure
This scale is used to assess fear of pain in children aged 5-10 years. It evaluates fear related to pain in children. The Child Fear Scale (CFS), developed by McMurty et al. (2011) and validated and proven reliable in Turkish by Özalp-Gerçeker et al. (2018), consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety), with a scoring system from 0 to 4. The scale's cutoff point is 2, and scores of 2 and above are considered high-level fear.
During the procedure
Change in the mean score of children in the Children's Emotional Manifestation Scale
Time Frame: during the procedure
The scale was developed by Li and Lopez in 2005. Its purpose is to objectively assess children's emotional responses to medical procedures. The scale evaluates children's emotional indicators based on five parameters: facial expression, vocal activity, interaction, and level of cooperation. Each parameter is scored between 1 and 5, with a minimum score of 5 and a maximum score of 25. The Turkish validity and reliability of the scale were established by İzci and Çetinkaya (2020) in children aged 7-12 years. The Cronbach's alpha reliability coefficient of the scale was found to be between 0.95 and 0.96.
during the procedure
Change in the mean score of children in the Children's comfort daisies scale
Time Frame: during the procedure
Developed by Kolcaba & DiMarco (2005) and with Turkish validity and reliability studies conducted by Kuzlu Ayyıldız et al. (2025), this scale consists of daisy-shaped facial expressions rated from 1 to 4 in response to nurses' question, "How do you feel?", for children aged 2-3 years who are able to communicate. Daisy number 1 means "very bad", 2 "somewhat bad", 3 "somewhat good", and 4 "very good". A higher score on the scale indicates a high level of comfort. In our study, the applicability of the scale for children aged 0-18 years was evaluated by observers, and it was determined that both age-appropriate children (through self-report) and observers (through observation) could use the scale.
during the procedure

Collaborators and Investigators

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

Sponsor

Mersin University

Investigators

  • Study Director: Derya Akdeniz Uysal, Study Director

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 (Estimated)

April 23, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MersinU-HB-OGP-03

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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