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

Not Applicable

Recruiting

• Conditions: Fear; Pain, Acute
• Interventions: Behavioral: puppet show

• Registration Number: NCT06013501
• Lead Sponsor: Dokuz Eylul University

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.

Study Timeline

• Study Start: 2023-01-03
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-12-03
• Study Completion: 2024-12-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Puppet Show Group	puppet show	puppet show before and during subcutaneous injection

Primary Outcome Measures

Name	Time	Method
procedure-related pain with Wong Baker Pain Rating Scale	change 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 Scale	change 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 scale	change 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 Outcome Measures

Name	Time	Method
Heart rate	change from the heart rate at 10 minutes	Heart rate measurement

Trial Locations

Locations (1)

Gülçin Özalp Gerçeker; 🇹🇷 İzmir, Turkey