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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07516249
Enrollment
96
Registered
2026-04-07
Start date
2026-04-23
Completion date
2026-10-30
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distraction Methods, Nursing Care

Keywords

Administration, Inhalation, Distraction methods, fear, comfort, cartoon

Brief 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.

Interventions

Active Distraction Methods

BEHAVIORALInteractive storytelling synchronized with breath

Active Distarction Methods

BEHAVIORALStandard Group

Standard care

Sponsors

Mersin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The participants were unaware of which group they were assigned to. The data will be entered using A, B and C codes, and the researcher doing the statistical analysis will be blind to the participants' groups.

Intervention model description

Block randomization was preferred to maintain balance in the number of children in the groups. Twelve different combinations \[ABCBAC (1), ACBBAC (2), AACCBB (3).\] were generated, each with a block size of 6 and containing codes A, B, and C. The combinations were numbered from 1 to 12. Combination numbers (1-12), each consisting of 16 numbers in a mixed order, were generated in a random order using a computer program (randomizer.org).Each child was assigned a number from 1 to 96 according to the order of inhaler drug administration. These numbers were placed in sealed opaque envelopes. Children and their parents will be masked as to which group they belong to. The implementing researchers will be masked as to the research hypotheses.The researchers who will enter the data will be masked as to the application group codes. Data entry will be performed with codes A, B, and C and will be shared with the researchers after statistical analyses are performed and the research report is written.

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the mean score of children in Children's Fear ScaleDuring the procedureThis 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.
Change in the mean score of children in the Children's Emotional Manifestation Scaleduring the procedureThe 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.
Change in the mean score of children in the Children's comfort daisies scaleduring the procedureDeveloped 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTÖzlem Güzel Polat
ozlemgzl@mersin.edu.tr+905067685660
CONTACTDerya Akdeniz Uysal
derya81@mersin.edu.tr
STUDY_DIRECTORDerya Akdeniz Uysal

Study Director

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026