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.
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
- Are there results?
- Not yet: the study is under way
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
- Recruiting
Hospital Ibn Al Atheer
Baghdad, Mousl, 41001
namir saeed mohammed, father, 07702091570, mohammed.saeed2404p@conursing.uobaghdad.edu.iq
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.
Read more
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.
- 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 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.
- 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.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Namir Saeed, University of Baghdad
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 30400357Li 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Effect of Toy Nebulizer Versus Distraction Cards on Children's Fear and Parental Satisfaction During Nebulization Therapy: A Comparative Study
- ClinicalTrials.gov ID
- NCT07417839
- Acronym / sponsor ID
- UOB-CON-2026-003
- Keywords
- "nebulization therapy", "fear", "distraction card"
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distraction Card | Experimental | Behavioral: distraction card |
| toy | Experimental | Behavioral: Nebuliser toy |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| distraction cardSet 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. | Behavioural | Distraction Card |
| Nebuliser toyChildren 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. | Behavioural | toy |
Primary outcome
Parental Satisfaction scale
Time frame: 9 month
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.
Children's Emotional Manifestation Scale
Time frame: 9 month
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 30400357Nik 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.
- Background: PubMed 15669931Li 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Satisfaction scale (time frame: 9 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07417839, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.