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

Pain, Acute Clinical Trial

— SC-puppet  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013501
• Other study ID #: SC-puppet
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: December 3, 2024

Study information

• Verified date: February 2024
• Source: Dokuz Eylul University
• Contact: Gülçin Özalp Gerçeker, pHD
• Phone: 905306411368
• Email: gulcinozalp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 3, 2024
• Est. primary completion date: December 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Fear
• Pain, Acute

Intervention

Behavioral:
• puppet show
puppet show to the child before and during subcutaneous application

Locations

Country	Name	City	State
Turkey	Gülçin Özalp Gerçeker	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Dokuz Eylul University	Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	procedure-related pain with Wong Baker Pain Rating Scale	pain assessment with Wong Baker Pain Rating Scale by child	change from Wong Baker Pain Rating Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
Primary	procedure-related fear with Child Fear Scale	fear assessment with Child Fear Scale by child and parent	change from Child Fear Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
Primary	procedure-related pain with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale	pain assessment with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale by nurse	change from The FLACC scale or Face, Legs, Activity, Cry, Consolability scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
Secondary	Heart rate	Heart rate measurement	change from the heart rate at 10 minutes