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

NCT ID: NCT06013501

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2024-12-03

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.

Conditions

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Pain, Acute Fear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Puppet Show Group

puppet show before and during subcutaneous injection

Group Type EXPERIMENTAL

puppet show

Intervention Type BEHAVIORAL

puppet show to the child before and during subcutaneous application

Control group

standart care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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puppet show

puppet show to the child before and during subcutaneous application

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role collaborator

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Gülçin Özalp Gerçeker

pHD, Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülçin Özalp Gerçeker, pHD

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

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Gülçin Özalp Gerçeker

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gülçin Özalp Gerçeker, pHD

Role: CONTACT

905306411368

Facility Contacts

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Gülçin Ö Gerçeker

Role: primary

05306411368

Other Identifiers

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SC-puppet

Identifier Type: -

Identifier Source: org_study_id

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