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The Effect of Cartoon Watching During Central Venous Catheter Dressing Changes in Children With Cancer

Primary Purpose

Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Watching Cartoon
Sponsored by
Mehmet Akif Ersoy University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Anxiety, Cancer, Cartoon, Central Venous Catheter, Child, Pain

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 5-12 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Pınar BEKAR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cartoon Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Children's Fear Scale
Each child's anxiety was evaluated with the "Children's Fear Scale" before, during and after the procedure by the child. It consists of five facial expressions representing a range from no anxiety (0) to severe anxiety (4).
Heart Rate
The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher before the procedure, during the procedure and after the procedure using a pulse oximeter device.
Oxygen Saturation
The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher before the procedure, during the procedure and after the procedure using a pulse oximeter device.

Full Information

First Posted
March 20, 2022
Last Updated
August 7, 2022
Sponsor
Mehmet Akif Ersoy University
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1. Study Identification

Unique Protocol Identification Number
NCT05301374
Brief Title
The Effect of Cartoon Watching During Central Venous Catheter Dressing Changes in Children With Cancer
Official Title
The Effect of Cartoon Watching on Anxiety and Pain During Central Venous Catheter Dressing Changes in Children With Cancer: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mehmet Akif Ersoy 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
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.
Detailed Description
This was a parallel randomized controlled trial with 80 children with cancer. They were randomly assigned to one of two groups, including 40 children in the control group and 40 children in the cartoon group. Each child's anxiety was evaluated by the child using the Children's Fear Scale before, during and after central venous catheter dressing changes, and each child's pain during and after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale. Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during and after the procedure. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
Anxiety, Cancer, Cartoon, Central Venous Catheter, Child, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cartoon Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Watching Cartoon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wong-Baker FACES Pain Rating Scale
Description
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)
Time Frame
4 MONTHS
Secondary Outcome Measure Information:
Title
Children's Fear Scale
Description
Each child's anxiety was evaluated with the "Children's Fear Scale" before, during and after the procedure by the child. It consists of five facial expressions representing a range from no anxiety (0) to severe anxiety (4).
Time Frame
4 MONTHS
Title
Heart Rate
Description
The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher before the procedure, during the procedure and after the procedure using a pulse oximeter device.
Time Frame
4 MONTHS
Title
Oxygen Saturation
Description
The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher before the procedure, during the procedure and after the procedure using a pulse oximeter device.
Time Frame
4 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 5-12 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine EFE, Prof.Dr.
Organizational Affiliation
Akdeniz University, Department of Child Health and Disease Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Pınar BEKAR
City
Burdur
Country
Turkey

12. IPD Sharing Statement

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The Effect of Cartoon Watching During Central Venous Catheter Dressing Changes in Children With Cancer

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