Distraction MethodsNCT07516249
Effects of Cartoons & Interactive Storytelling on Fear and Comfort in 6-9 Year Olds During Nebulizer Treatment
A study testing Cartoon Watching, Interactive storytelling synchronized with breath and Standard Group in people with Distraction Methods and Nursing Care, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Distraction Methods, Nursing Care
- What is being tested?
- Cartoon Watching, Interactive storytelling synchronized with breath and Standard Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Apr 2026to 30 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Derya Akdeniz Uysal contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mersin University
Mersin, 33100
Derya Akdeniz Uysal, +905054676068, derya81@mersin.edu.tr
Özlem Güzel Polat
About this study
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
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.
Read the 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
- Distraction Methods, Nursing Care
- Being tested
- Cartoon Watching, Interactive storytelling synchronized with breath, Standard Group
- Keywords
- Administration, Inhalation, Distraction methods, fear, comfort, cartoon
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartoon WatchingBehavioural
Active Distraction Methods
Interactive storytelling synchronized with breathBehavioural
Active Distarction Methods
Standard GroupBehavioural
Standard care
| Study group | Role | What they receive |
|---|---|---|
| cartoon group: CG | Experimental | 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. Receives: Behavioral: Cartoon Watching |
| Breath-Synchronized Interactive Storytelling Group (SWB-ISG) | Experimental | 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. Receives: Behavioral: Interactive storytelling synchronized with breath |
| Standard Care Group (SG) | Experimental | 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. Receives: Behavioral: Standard Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the procedure
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.
Measured: during the procedure
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.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start23 Apr 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Distraction MethodsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Guzel Polat, Mersin University
- Investigators
- Derya Akdeniz Uysal, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516249
- Sponsor's protocol ID
- MersinU-HB-OGP-03
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29160486Altay 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.
PubMed 41016223Şahin, 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.
PubMed 224359863. 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.
PubMed 15750381Kirkan 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.
PubMed 37940393