An interventional study of distraction card and Nebuliser toy in Fear is a Common Psychological Response Undergoing Medical Procedures,Act From Uncertainty, Anticipation of Pain, Loss of Control, Previous Negative Experiences, sponsored by University of Baghdad. Recruiting at 1 site in Iraq. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by University of Baghdad · Not applicable, Interventional, and Supportive care
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 obtained from the parents and assent from the child (where applicable).
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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.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: distraction card
Behavioral: Nebuliser toy
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.
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.
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.
Time frame: 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.
Time frame: 9 month
Plan to share: No
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