The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes in Children With Cancer

Study Overview
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Brief Summary
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Many medical interventions, including the dressing of central venous catheters, a common procedure used for children with cancer, cause anxiety and pain in children. This can adversely affect their care and recovery. This study aims to determine the effect of using a kaleidoscope during central venous catheter dressing on anxiety and pain in children with cancer.

Detailed Description
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This was a randomised controlled trial with 60 children aged 6-12 diagnosed with cancer who were placed either in a kaleidoscope group (n=30) or a control group (n=30). Each child's anxiety was evaluated by the child using the Child Fear Scale before, during and after a central venous catheter dressing procedure, and each child's pain during and after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale (WB-FACES). Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during and after central venous catheter dressing. The children in kaleidoscope group looked into the kaleidoscope and slowly turned it. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished. No intervention was performed to reduce pain and anxiety for children in the control group. Parents accompanied their children during the procedure in both groups.

Official Title
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The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes on Anxiety and Pain in Children With Cancer: A Randomised Controlled Study

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Behavioral: kaleidoscope application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a cancer diagnosis, having a central venous catheter, 6-12 years old, not having taken any analgesics in the 6 hours before the central venous catheter dressing, -being in a non-terminal phase of the disease, absence of neutropenia, volunteering to participate in the study, the absence of any health problems that prevent communication in the parent or the child. Exclusion Criteria: -the reporting of pain for another reason at the time of the central venous catheter dressing.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization was done using the closed-envelope method. A total of 60 cards, equally divided between the kaleidoscope and control groups (30 of each), were placed in sealed envelopes. The children were asked to choose one of these envelopes, which determined their placement in the kaleidoscope group or the control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kaleidoscope Group<br>Children in this group were told what a kaleidoscope is and how to use it before their central venous catheter dressing. The children were then asked if they would like to look into the kaleidoscope. The children looked into the kaleidoscope and slowly turned it. The researcher asked the children about the colours and shapes seen inside the kaleidoscope. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished. The kaleidoscope was disinfected before each use. A kaleidoscope was provided for all children in this group by the same researcher. Parents accompanied their children during the catheter dressing. | Behavioral: kaleidoscope application<br>* The children looked into the kaleidoscope and slowly turned it. The researcher asked the children about the colours and shapes seen inside the kaleidoscope. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.<br>|
| No Intervention: Control Group<br>No intervention was performed to reduce pain and anxiety for children in the control group. Parents accompanied their children during the procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wong-Baker FACES Pain Rating Scale (WB-FACES) | The Wong-Baker Faces Pain Rating Scale (WB-FACES) is used to evaluate pain levels in children. This numeric rating scale ranges from 0 to 10 and is represented by faces that display emotions ranging from smiling (0 = very happy or no pain) to crying (10 = the worst pain). | 5 MONTHS | 
| Children's Fear Scale (CFS) | The Children's Fear Scale (CFS) is used to evaluate anxiety levels in children. It consists of five facial expressions representing a range from no anxiety (0) to severe anxiety (4). | 5 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher 3 minutes before the procedure, during the procedure and 5 minutes after the procedure using a pulse oximeter device. | 5 MONTHS | 
| Oxygen Saturation | The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher 3 minutes before the procedure, during the procedure and 5 minutes after the procedure using a pulse oximeter device. | 5 MONTHS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Anxiety, Central venous catheter, Child, Pain