About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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.)
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Cartoon Watching
BehavioralActive Distraction Methods
Interactive storytelling synchronized with breath
BehavioralActive Distarction Methods
Standard Group
BehavioralStandard care
Treatment groups
Trial outcomes
Primary outcomes
Change in the mean score of children in Children's Fear Scale
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.
Change in the mean score of children in the Children's Emotional Manifestation Scale
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.
Change in the mean score of children in the Children's comfort daisies scale
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.
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