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The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia

The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia: A Randomized Controlled Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06013501
Acronym
SC-puppet
Enrollment
60
Registered
2023-08-28
Start date
2023-01-03
Completion date
2024-12-03
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fear, Pain, Acute

Brief summary

This study aim to evaluate the effect of puppet show applied during subcutaneous injection to children aged 3-7 years with leukemia on the level of pain and fear experienced by children due to the intervention.

Detailed description

Before and during subcutaneous injection administration to the children in the study group There will be a puppet show. No distraction method will be applied to the children in the control group and the clinical A subcutaneous injection will be administered in accordance with the routine. Pain and fear assessment of children in both groups will be evaluated by the clinical nurse during the intervention.

Interventions

BEHAVIORALpuppet show

puppet show to the child before and during subcutaneous application

Sponsors

Ege University
CollaboratorOTHER
Dokuz Eylul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomised

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
procedure-related pain with Wong Baker Pain Rating Scalechange from Wong Baker Pain Rating Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)pain assessment with Wong Baker Pain Rating Scale by child
procedure-related fear with Child Fear Scalechange from Child Fear Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)fear assessment with Child Fear Scale by child and parent
procedure-related pain with The FLACC scale or Face, Legs, Activity, Cry, Consolability scalechange from The FLACC scale or Face, Legs, Activity, Cry, Consolability scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)pain assessment with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale by nurse

Secondary

MeasureTime frameDescription
Heart ratechange from the heart rate at 10 minutesHeart rate measurement

Countries

Turkey (Türkiye)

Contacts

Primary ContactGülçin Özalp Gerçeker, pHD
gulcinozalp@gmail.com905306411368

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026