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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924023
• Other study ID #: KAEK-791
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2021
• Source: Mehmet Akif Ersoy University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Behavioral:
• kaleidoscope application
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.

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 (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
Primary	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	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
Secondary	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