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

Sponsor
Dokuz Eylul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06013501
Collaborator
Ege University (Other)
60
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: puppet show
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
RandomisedRandomised
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia: A Randomized Controlled Study
Actual Study Start Date :
Jan 3, 2023
Anticipated Primary Completion Date :
Jan 3, 2024
Anticipated Study Completion Date :
Jan 3, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  1. Heart rate [change from the heart rate at 10 minutes]

    Heart rate measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 7 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gülçin Özalp Gerçeker İzmir Turkey 35100

Sponsors and Collaborators

  • Dokuz Eylul University
  • Ege University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gülçin Özalp Gerçeker, pHD, Assoc. Prof., Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT06013501
Other Study ID Numbers:
  • SC-puppet
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acute Pain

Study Results

No Results Posted as of Aug 28, 2023