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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05301374
Other study ID # KAEK-610
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date February 28, 2022

Study information

Verified date August 2022
Source Mehmet Akif Ersoy University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Watching Cartoon
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.

Locations

Country Name City State
Turkey Pinar BEKAR Burdur

Sponsors (1)

Lead Sponsor Collaborator
Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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). 4 MONTHS
Secondary 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. 4 MONTHS
Secondary 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. 4 MONTHS
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