Trials / Not Yet Recruiting
Not Yet RecruitingNCT07516249
Effects of Cartoons & Interactive Storytelling on Fear and Comfort in 6-9 Year Olds During Nebulizer Treatment
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- Sponsor
- Mersin University · Academic / Other
- Sex
- All
- Age
- 6 Years – 9 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cartoon Watching | Active Distraction Methods |
| BEHAVIORAL | Interactive storytelling synchronized with breath | Active Distarction Methods |
| BEHAVIORAL | Standard Group | Standard care |
Timeline
- Start date
- 2026-04-23
- Primary completion
- 2026-06-30
- Completion
- 2026-10-30
- First posted
- 2026-04-07
- Last updated
- 2026-04-07
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07516249. Inclusion in this directory is not an endorsement.