(Effect of Toy Nebulizer Versus Distraction Cards on Children's Fear and Parental Satisfaction During Nebulization Therapy: A Comparative Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: distraction card, Nebuliser toy.
- Who it may be relevant to
- Registry conditions: Fear is a Common Psychological Response Undergoing Medical Procedures,Act From Uncertainty, Anticipation of Pain, Loss of Control, Previous Negative Experiences. Basic parameters: 3 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Goal To compare the effectiveness of a toy nebulizer versus distraction cards in reducing fear among children during nebulization therapy while improving parental satisfaction. Aim To evaluate and measure children's fear levels and parents' satisfaction when using toy nebulizers compared to distraction cards in nebulization sessions. Null hypothesis: (Hᴏ) There is no statistically significant difference in fear levels among children, and parental satisfaction scores in in the toy nebulizer, distraction cards, and control groups. Alternative hypothesis: (H₁) There is a statistically significant difference in fear levels among children, and parental satisfaction scores in the toy nebulizer, distraction cards, and control groups.
Detailed description
Background Nebulization therapy is essential for children with respiratory conditions like asthma, but it often causes significant fear and anxiety in young patients. Distraction techniques help reduce distress, yet more engaging methods like toy nebulizers may offer better outcomes. This study compares these two non-pharmacological interventions.
Study Design A comparative randomized controlled trial involving children aged 3-8 years undergoing nebulization. Participants are randomly assigned to either a toy nebulizer group (interactive play device mimicking nebulization) or distraction cards group (visual/pictorial cards). Fear levels are assessed using the Child Fear Scale (CFS), and parental satisfaction via a 5-point Likert scale.
Objectives Primary: Measure reduction in children's fear during therapy.
Secondary: Evaluate parental satisfaction and therapy completion rates.
Procedures Sessions occur in a pediatric clinic over 4 weeks (3 sessions per child). Pre- and post-session assessments capture fear and satisfaction data. Data analysis uses t-tests and ANOVA for statistical significance (p\<0.05).
Expected Outcomes Toy nebulizers are hypothesized to lower fear more effectively than distraction cards, leading to higher parental satisfaction and better adherence to therapy.
Interventions
- Behavioral distraction card
Set of 3-6 colorful picture cards featuring engaging images (animals, counting games, hidden objects) held 12-18 inches from the child's face during nebulization. Nurse flips cards every 1-2 minutes while prompting interactive questions (e.g., "How many stars?" or "Find the bear") to cognitively distract the child aged 3-6 from the mask, promoting calm breathing over 10-15 minute sessions (3x/week for 4 weeks). Used as non-physical, passive distraction in the control arm. - Behavioral Nebuliser toy
Children aged 3-6 receive nebulization therapy using an interactive toy nebulizer (animal-shaped mask with playful features like a blow-out tongue). Nurse guides play-based breathing games during 10-15 minute sessions (3x/week for 4 weeks) to reduce fear while delivering medication.
Primary outcome measures
- Parental Satisfaction scale [Time frame: 9 month]
- Children's Emotional Manifestation Scale [Time frame: 9 month]
Eligibility criteria
Inclusion Criteria:Children aged 3-6 years receiving nebulization therapy for the first time due to acute respiratory conditions (e.g., asthma or bronchitis).
2\. Presence of at least one parent (preferably the mother) during the procedure who is capable of evaluation and communication in Arabic or Kurdish.
3\. Children who are alert and able to cooperate (absence of severe pain or any condition preventing basic communication).
4\. Voluntary written informed consent obtained from the parents and assent from the child (where applicable).
\-
Exclusion Criteria:Prior history of nebulization therapy (to ensure the fear response is not conditioned by past experiences).
2\. Children with cognitive, neurological, or developmental disabilities, or severe chronic illnesses (e.g., terminal cancer).
3\. Parental inability to complete fear or satisfaction questionnaires due to disability or illiteracy.
4\. Refusal to participate by the child or parent, or the presence of emergency conditions requiring immediate life-saving intervention.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Iraq · 1 center
- Hospital Ibn Al Atheer — Baghdad
Publications
- Nik Adib NA, Ibrahim MI, Ab Rahman A, Bakar RS, Yahaya NA, Hussin S, Nor Arifin W. Translation and Validation of the Malay Version of the Parents' Satisfaction Scale (PSS-M) for Assessment of Caregivers' Satisfaction with Health Care Services for Children with Autism Spectrum Disorder. Int J Environ Res Public Health. 2018 Nov 4;15(11):2455. doi: 10.3390/ijerph15112455. PMID 30400357
- Li HC, Lopez V. Children's Emotional Manifestation Scale: development and testing. J Clin Nurs. 2005 Feb;14(2):223-9. doi: 10.1111/j.1365-2702.2004.01031.x. PMID 15669931
Identifiers
NCT: NCT07417839 · UOB-CON-2026-003