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The Effect of Using a Kaleidoscope 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
kaleidoscope application
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, Central venous catheter, Child, Pain

Eligibility Criteria

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

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.

Sites / Locations

  • Pınar BEKAR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Kaleidoscope Group

Control Group

Arm Description

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.

No intervention was performed to reduce pain and anxiety for children in the control group. Parents accompanied their children during the procedure.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 7, 2021
Last Updated
December 9, 2021
Sponsor
Mehmet Akif Ersoy University
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1. Study Identification

Unique Protocol Identification Number
NCT04924023
Brief Title
The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes in Children With Cancer
Official Title
The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes on Anxiety and Pain in Children With Cancer: A Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
Anxiety, Cancer, Central venous catheter, Child, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kaleidoscope Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention was performed to reduce pain and anxiety for children in the control group. Parents accompanied their children during the procedure.
Intervention Type
Behavioral
Intervention Name(s)
kaleidoscope application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wong-Baker FACES Pain Rating Scale (WB-FACES)
Description
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).
Time Frame
5 MONTHS
Title
Children's Fear Scale (CFS)
Description
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).
Time Frame
5 MONTHS
Secondary Outcome Measure Information:
Title
Heart Rate
Description
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.
Time Frame
5 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 3 minutes before the procedure, during the procedure and 5 minutes after the procedure using a pulse oximeter device.
Time Frame
5 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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

Plan to Share IPD
No
Citations:
PubMed Identifier
35248915
Citation
Bekar P, Erkul M, Efe E. The effect of using a kaleidoscope during central venous catheter dressing changes on pain and anxiety in children with cancer: A randomised controlled trial. Eur J Oncol Nurs. 2022 Apr;57:102114. doi: 10.1016/j.ejon.2022.102114. Epub 2022 Feb 25.
Results Reference
derived

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

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