Using toys and cartoon masks to reduce pain and anxiety in children during medical procedures
The Effect of Using Toy and Cartoon Character Masks on Pain and Anxiety During Peripheral Intravenous Catheterization in Children
This study tests whether using toys and cartoon masks can help reduce pain and anxiety in children during medical procedures like getting an IV.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (İstanbul, Şişli) |
| Trial ID | NCT05892107 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of using a cartoon character mask and allowing children to play with toys during intravenous catheterization to alleviate pain and anxiety. It aims to enhance the experience of children undergoing painful medical procedures by employing nonpharmacologic techniques. The study will compare outcomes between a toy group, a mask group, and a control group to determine the most effective approach for reducing distress in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children who require intravenous catheterization and meet specific health criteria without chronic pain or neurological disabilities.
Not a fit: Patients who have chronic diseases requiring frequent invasive procedures or those who have taken analgesic medications within the last six hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the emotional and physical experiences of children undergoing painful medical procedures.
How similar studies have performed: Other studies have shown success with nonpharmacologic approaches to pain management in children, indicating that this method may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The parent's verbal and written acceptance of the informed consent form, * The child has not been given any medication with analgesic effect in the last 6 hours, * Opening the vascular access on the first attempt, * Body temperature between 36.5-37.2⁰C, * The child does not have a chronic disease that requires frequent invasive procedures, * The child does not have a disease that can cause chronic pain, * The child does not have a mental or neurological disability that would affect participation in the research Exclusion Criteria: * Failure of the parent to verbally and in writing accept the informed consent form for participation in the study, * The child has taken a drug with analgesic, antipyretic, anti-inflammatory effect in the last 6 hours, * Failure to open the vascular access on the first attempt, * The child's body temperature is above 37.2⁰C, * Have a chronic disease that requires frequent invasive procedures, * The child has a disease that can cause chronic pain, * The child has an intellectual or neurological disability.
Where this trial is running
İstanbul, Şişli
- Songül Okşar — İstanbul, Şişli, Turkey (Recruiting)
Study contacts
- Principal investigator: Birsen MUTLU, Ph.d — Istanbul University - Cerrahpasa
- Study coordinator: Songül OKŞAR
- Email: songul.gezer@iuc.edu.tr
- Phone: +90 +90 212 414 3000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.