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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Acute, Fear

Intervention / Treatment
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* Behavioral: puppet show


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomised
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 Outcome Measures

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