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

NCT06013501 | Recruiting

• 1 other identifier: SC-puppet
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Fear

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Heart rate

  change from the heart rate at 10 minutes

Study Arms (2)

Puppet Show Group

EXPERIMENTAL

puppet show before and during subcutaneous injection

Behavioral: puppet show

Control group

NO INTERVENTION

standart care

Interventions

puppet show BEHAVIORAL

puppet show to the child before and during subcutaneous application

Puppet Show Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Ege University: collaborator

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülçin Özalp Gerçeker, pHD

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülçin Özalp Gerçeker, pHD

CONTACT

905306411368; gulcinozalp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pHD, Assoc. Prof.

Model Details: Randomised

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: August 28, 2023
• Study Start: January 3, 2023
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)