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(Effect of Toy Nebulizer Versus Distraction Cards on Children's Fear and Parental Satisfaction During Nebulization Therapy: A Comparative Study

NCT07417839 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-27

No results posted yet for this study

Summary

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.

Conditions

  • Fear is a Common Psychological Response Undergoing Medical Procedures,Act From Uncertainty, Anticipation of Pain, Loss of Control, Previous Negative Experiences

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.

Sponsors & Collaborators

  • University of Baghdad

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2026-07-01
Completion
2026-08-01

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07417839 on ClinicalTrials.gov