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

NCT07417839 | Not Yet Recruiting

• 1 other identifier: UOB-CON-2026-003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

"nebulization therapy"; "fear"; "distraction card"

Outcome Measures

Primary Outcomes (2)

• Parental Satisfaction scale

  The one-dimensional PSS is a self-administered questionnaire consisting of 11 statements or items.Each statement had five Likert scale responses ranging from one to four with score 1 representing strongly disagree and score 5 representing strongly agree. Higher scores indicate higher level of satisfaction on the interpersonal relationship with professional. The respondents were asked to choose one best response for each statement.

  9 month

• Children's Emotional Manifestation Scale

  Children's Emotional Manifestation Scale: instruction Observe the child's behaviour throughout the entire medical procedure. Once the procedure is finished, immediately select in each category the number that most closely describes the observed behaviour during the procedure. Always refer back to the operational definition when you have difficulty or are unclear in rating the child's behaviour. Each category is scored on a 1-5 scale, resulting in a total score of 5 -25. These child behaviours will determine the extent of their fear of nebulizer.

  9 month

Study Arms (2)

Distraction Card

EXPERIMENTAL

Behavioral: distraction card

toy

EXPERIMENTAL

Behavioral: Nebuliser toy

Interventions

distraction card BEHAVIORAL

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.

Distraction Card

Nebuliser toy BEHAVIORAL

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.

toy

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Presence of at least one parent (preferably the mother) during the procedure who is capable of evaluation and communication in Arabic or Kurdish.
• \. Children who are alert and able to cooperate (absence of severe pain or any condition preventing basic communication).
• \. Voluntary written informed consent obtained from the parents and assent from the child (where applicable).

You may not qualify if:

• \. Children with cognitive, neurological, or developmental disabilities, or severe chronic illnesses (e.g., terminal cancer).
• \. Parental inability to complete fear or satisfaction questionnaires due to disability or illiteracy.
• \. Refusal to participate by the child or parent, or the presence of emergency conditions requiring immediate life-saving intervention.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Hospital Ibn Al Atheer

Baghdad, Mousl, 41001, Iraq

Location

Related Publications (2)

• 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. International journal of environmental research and public health. 2018 Nov;15(11):2455.

  BACKGROUND

• Li HC, Lopez V. Children's Emotional Manifestation Scale: development and testing. Journal of Clinical Nursing. 2005 Feb;14(2):223-9.

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 18, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)