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

Primary Purpose

Pain, Acute, Fear

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
puppet show
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Acute

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gülçin Özalp GerçekerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Puppet Show Group

Control group

Arm Description

puppet show before and during subcutaneous injection

standart care

Outcomes

Primary Outcome Measures

procedure-related pain with Wong Baker Pain Rating Scale
pain assessment with Wong Baker Pain Rating Scale by child
procedure-related fear with Child Fear Scale
fear assessment with Child Fear Scale by child and parent
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

Secondary Outcome Measures

Heart rate
Heart rate measurement

Full Information

First Posted
March 30, 2023
Last Updated
August 25, 2023
Sponsor
Dokuz Eylul University
Collaborators
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT06013501
Brief Title
The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia
Acronym
SC-puppet
Official Title
The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
January 3, 2024 (Anticipated)
Study Completion Date
January 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
Collaborators
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Fear

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomised
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Puppet Show Group
Arm Type
Experimental
Arm Description
puppet show before and during subcutaneous injection
Arm Title
Control group
Arm Type
No Intervention
Arm Description
standart care
Intervention Type
Behavioral
Intervention Name(s)
puppet show
Intervention Description
puppet show to the child before and during subcutaneous application
Primary Outcome Measure Information:
Title
procedure-related pain with Wong Baker Pain Rating Scale
Description
pain assessment with Wong Baker Pain Rating Scale by child
Time Frame
change from Wong Baker Pain Rating Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
Title
procedure-related fear with Child Fear Scale
Description
fear assessment with Child Fear Scale by child and parent
Time Frame
change from Child Fear Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
Title
procedure-related pain with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale
Description
pain assessment with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale by nurse
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)
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate measurement
Time Frame
change from the heart rate at 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gülçin Özalp Gerçeker, pHD
Phone
905306411368
Email
gulcinozalp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülçin Özalp Gerçeker, pHD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gülçin Özalp Gerçeker
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gülçin Ö Gerçeker
Phone
05306411368
Email
gulcinozalp@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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