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

NCT07516249 | Recruiting DMC

• 1 other identifier: MersinU-HB-OGP-03
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Distraction Methods; Nursing Care

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  during the procedure

Study Arms (3)

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.

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.

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.

Behavioral: Standard Group

Interventions

Standard Group BEHAVIORAL

Standard care

Standard Care Group (SG)

Cartoon Watching BEHAVIORAL

Active Distraction Methods

cartoon group: CG

Interactive storytelling synchronized with breath BEHAVIORAL

Active Distarction Methods

Breath-Synchronized Interactive Storytelling Group (SWB-ISG)

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, 33100, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• 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 RESULT

• 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 RESULT

• 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.

  RESULT

• 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

  RESULT

• 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 RESULT

• 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

  RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Derya Akdeniz Uysal

  Study Director

  STUDY DIRECTOR

Central Study Contacts

Özlem Güzel Polat

CONTACT

+905067685660; ozlemgzl@mersin.edu.tr

Derya Akdeniz Uysal

CONTACT

derya81@mersin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: April 7, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)