- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05301374
The Effect of Cartoon Watching During Central Venous Catheter Dressing Changes in Children With Cancer
The Effect of Cartoon Watching on Anxiety and Pain During Central Venous Catheter Dressing Changes in Children With Cancer: A Randomized Controlled Trial
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Burdur, Turkey
- Pınar BEKAR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cartoon Group
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.
|
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.
|
|
No Intervention: Control Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wong-Baker FACES Pain Rating Scale
Time Frame: 4 MONTHS
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Fear Scale
Time Frame: 4 MONTHS
|
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).
|
4 MONTHS
|
|
Heart Rate
Time Frame: 4 MONTHS
|
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.
|
4 MONTHS
|
|
Oxygen Saturation
Time Frame: 4 MONTHS
|
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.
|
4 MONTHS
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Emine EFE, Prof.Dr., Akdeniz University, Department of Child Health and Disease Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEK-610
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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