Using puppet shows to reduce pain and fear during injections in children with leukemia
The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia: A Randomized Controlled Study
NA · Dokuz Eylul University · NCT06013501
This study tests if a puppet show can help young children with leukemia feel less pain and fear during their injections.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Sponsor | Dokuz Eylul University (other) |
| Locations | 1 site (İzmir) |
| Trial ID | NCT06013501 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a puppet show as a distraction technique during subcutaneous injections in children aged 3-7 years who are being treated for leukemia. Children in the study group will experience a puppet show before and during their injection, while a control group will receive the injection without any distraction. Pain and fear levels will be assessed by a clinical nurse during the procedure to determine the impact of the puppet show on these experiences.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-7 years who are receiving treatment for leukemia.
Not a fit: Patients who are medically unstable or unable to communicate may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and fear in young children undergoing medical procedures.
How similar studies have performed: Other studies have shown that distraction techniques can effectively reduce pain and anxiety in pediatric patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Child \<3 and \>7 years old * Medically unstable (dehydration, septic shock, sedation) * Children who are being treated for leukemia in the Pediatric Hematology Service will be included in the study. Exclusion Criteria: * Not exposed to any other interventional procedure before (same day) subcutaneous intervention * Not expressing any pain before subcutaneous intervention * Heart rate to be within age-appropriate limits * Wong-Baker Pain Rating Scale score of 0 in the evaluation performed before the subcutaneous intervention (5 minutes ago) * Having a disability that cannot perceive the attempt and communicate (down syndrome, speech disorder, visual impairment) * The child and family do not know Turkish
Where this trial is running
İzmir
- Gülçin Özalp Gerçeker — İzmir, Turkey (RECRUITING)
Study contacts
- Principal investigator: Gülçin Özalp Gerçeker, pHD — Dokuz Eylul University
- Study coordinator: Gülçin Özalp Gerçeker, pHD
- Email: gulcinozalp@gmail.com
- Phone: 905306411368
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.
Conditions: Pain, Acute, Fear