NCT05301374

Brief Summary

Many medical interventions, including dressing change of central venous catheters, can cause anxiety and pain in children with cancer. The aim of this study is to determine the effect of cartoon watching technique on anxiety and pain during central venous catheter dressing changes in children with cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

March 20, 2022

Last Update Submit

August 7, 2022

Conditions

Keywords

AnxietyCancerCartoonCentral Venous CatheterChildPain

Outcome Measures

Primary Outcomes (1)

  • Wong-Baker FACES Pain Rating Scale

    Each child's pain during and after the procedure was evaluated with the "Wong Baker Faces Pain Rating Scale" by the child. The scale consists of faces ranging from no hurt (0) to hurts worst (10)

    4 MONTHS

Secondary Outcomes (3)

  • Children's Fear Scale

    4 MONTHS

  • Heart Rate

    4 MONTHS

  • Oxygen Saturation

    4 MONTHS

Study Arms (2)

Cartoon Group

EXPERIMENTAL

Children in the cartoon group before the procedure, they chose one of the cartoons predetermined by the researchers. The children in the cartoon group started watching a cartoon of their choice 2 minutes before the procedure and they kept watching until the procedure was ended. Parent was with their children during the procedure in both groups.

Behavioral: Watching Cartoon

Control Group

NO INTERVENTION

No intervention was performed to reduce anxiety and pain for children in the control group. Parent was with their children during the procedure in both groups.

Interventions

Children in the cartoon group before the procedure, they chose one of the cartoons predetermined by the researchers. The children in the cartoon group started watching a cartoon of their choice 2 minutes before the procedure and they kept watching until the procedure was ended.

Cartoon Group

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • a cancer diagnosis
  • having a central venous catheter
  • not having taken any analgesics in the 6 hours before the procedure
  • not having any visual or auditory problems that prevent watching cartoons
  • being suitable motor development and cognitive level for watching cartoons
  • being a child and parent volunteering to participate in the study
  • the absence of any health problems that prevent communication in the parent and the child

You may not qualify if:

  • the reporting of pain for another reason at the time of the central venous catheter dressing changes
  • being of neutropenia
  • being in a terminal phase of the disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pınar BEKAR

Burdur, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety DisordersNeoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Emine EFE, Prof.Dr.

    Akdeniz University, Department of Child Health and Disease Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 20, 2022

First Posted

March 29, 2022

Study Start

December 1, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

August 10, 2022

Record last verified: 2022-08

Locations