Fear is a Common Psychological Response Undergoing Medical Procedures,Act From Uncertainty, Anticipation of Pain, Loss of Control, Previous Negative ExperiencesNCT07417839

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

A study testing distraction card and Nebuliser toy in people with Fear is a Common Psychological Response Undergoing Medical Procedures,Act From Uncertainty, Anticipation of Pain, Loss of Control, Previous Negative Experiences, run by University of Baghdad at 1 site in Iraq.

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Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 3 to 6 years
Conditions the study is for: Fear is a Common Psychological Response Undergoing Medical Procedures,Act From Uncertainty, Anticipation of Pain, Loss of Control, Previous Negative Experiences
What is being tested?: distraction card and Nebuliser toy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteIraq
Study dates: 8 Apr 2026to 1 Aug 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 3 to 6 years
All sexes
No healthy volunteers
Child

Inclusion Criteria:Children aged 3-6 years receiving nebulization therapy for the first time due to acute respiratory conditions (e.g., asthma or bronchitis).

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).

Exclusion Criteria:Prior history of nebulization therapy (to ensure the fear response is not conditioned by past experiences).

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Iraq1 site, 1 recruiting

Hospital Ibn Al Atheer
Baghdad, Mousl, 41001
namir saeed mohammed, father, 07702091570, mohammed.saeed2404p@conursing.uobaghdad.edu.iq
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About this study

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.

Read the 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.

Conditions: Fear is a Common Psychological Response Undergoing Medical Procedures,Act From Uncertainty, Anticipation of Pain, Loss of Control, Previous Negative Experiences
Being tested: distraction card, Nebuliser toy
Keywords: "nebulization therapy", "fear", "distraction card"

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

distraction cardBehavioural
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.
Nebuliser toyBehavioural
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.

Study groups in NCT07417839
Study group	Role	What they receive
Distraction Card	Experimental	Not described Receives: Behavioral: distraction card
toy	Experimental	Not described Receives: Behavioral: Nebuliser toy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 9 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 20261 Aug 2026

First posted18 Feb 2026
Study start8 Apr 2026
Primary completion1 Jul 2026
Study completion1 Aug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Fear is a Common Psychological Response Undergoing Medical Procedures,Act From Uncertainty, Anticipation of Pain, Loss of Control, Previous Negative ExperiencesStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07417839
Sponsor's protocol ID: UOB-CON-2026-003
Status last verified: Mar 2026
First submitted: 6 Feb 2026
Last updated: 3 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 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.
PubMed 15669931