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Clinical Trials/NCT06013501
NCT06013501
Recruiting
N/A

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

Dokuz Eylul University1 site in 1 country60 target enrollmentJanuary 3, 2023
ConditionsPain, AcuteFear

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
Dokuz Eylul University
Enrollment
60
Locations
1
Primary Endpoint
procedure-related pain with Wong Baker Pain Rating Scale
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2023
End Date
December 3, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gülçin Özalp Gerçeker

pHD, Assoc. Prof.

Dokuz Eylul University

Eligibility 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

Outcomes

Primary Outcomes

procedure-related pain with Wong Baker Pain Rating Scale

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Heart rate(change from the heart rate at 10 minutes)

Study Sites (1)

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