The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia (SC-puppet)

February 2, 2024 updated by: Gülçin Özalp Gerçeker, Dokuz Eylul University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • İzmir, Turkey, 35100
        • Recruiting
        • Gülçin Özalp Gerçeker
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Puppet Show Group
puppet show before and during subcutaneous injection
Behavioral: puppet show
puppet show to the child before and during subcutaneous application
No Intervention: Control group
standart care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from Wong Baker Pain Rating Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
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
change from Child Fear Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
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
change from The FLACC scale or Face, Legs, Activity, Cry, Consolability scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: change from the heart rate at 10 minutes
Heart rate measurement
change from the heart rate at 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Collaborators

Ege University

Investigators

  • Principal Investigator: Gülçin Özalp Gerçeker, pHD, Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Estimated)

December 3, 2024

Study Completion (Estimated)

December 3, 2024

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC-puppet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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