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

Official title

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

Overview

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.

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.

Interventions

• Behavioral Cartoon Watching
  Active Distraction Methods
• Behavioral Interactive storytelling synchronized with breath
  Active Distarction Methods
• Behavioral Standard Group
  Standard care

Primary outcome measures

• Change in the mean score of children in Children's Fear Scale [Time frame: During the procedure]
• Change in the mean score of children in the Children's Emotional Manifestation Scale [Time frame: during the procedure]
• Change in the mean score of children in the Children's comfort daisies scale [Time frame: during the procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Mersin University — Mersin

Publications

• Silva SGTD, Santos MA, Floriano CMF, Damiao EBC, Campos FV, Rossato LM. Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial. Rev Bras Enferm. 2017 Nov-Dec;70(6):1244-1249. doi: 10.1590/0034-7167-2016-0353. English, Portuguese. PMID 29160486
• Altay G, Metin Karaaslan M, Yildiz Y, Demir E. The effect of toy-figure nebulizer along with amigurumi-based therapeutic play, and auditory stimulus reduction during inhalation therapy in children: A randomized controlled trial. J Pediatr Nurs. 2025 Nov-Dec;85:577-585. doi: 10.1016/j.pedn.2025.09.021. Epub 2025 Sep 27. PMID 41016223
• Şahin, A., & Arıkan, D. (2022). The Effects of Self-Efficacy and Anxiety Levels of Mothers with Children Receiving Nebulized Inhalation Treatment on the Application of Nebulized Inhalation Practices. Sakarya University Journal of Holistic Health, 5(3), 327-341.
• Kemps, E., Scullin, M. K., & Upton, L. (2019). Effects of mindful breathing on attention, negative affect and stress in children. Journal of Child and Family Studies, 28(7), 1928-1939. https://doi.org/10.1007/s10826-019-01419-4
• Inal S, Kelleci M. Distracting children during blood draw: looking through distraction cards is effective in pain relief of children during blood draw. Int J Nurs Pract. 2012 Apr;18(2):210-9. doi: 10.1111/j.1440-172X.2012.02016.x. PMID 22435986
• 3. Aydın, D., & Şahiner, N. C. (2017). Effects of distraction on pain, fear and anxiety during invasive procedures in children. Journal for Specialists in Pediatric Nursing, 22(3), e12184. https://doi.org/10.1111/jspn.12184
• Brown RP, Gerbarg PL. Sudarshan Kriya yogic breathing in the treatment of stress, anxiety, and depression: part I-neurophysiologic model. J Altern Complement Med. 2005 Feb;11(1):189-201. doi: 10.1089/acm.2005.11.189. PMID 15750381
• Kirkan C, Kahraman A. Effect of therapeutic play using a toy nebulizer and toy mask on a child's fear and anxiety levels. J Pediatr Nurs. 2023 Nov-Dec;73:e556-e562. doi: 10.1016/j.pedn.2023.10.033. Epub 2023 Nov 7. PMID 37940393

Identifiers

NCT: NCT07516249 · MersinU-HB-OGP-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗