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

NCT04924023 | Completed

• 1 other identifier: KAEK-791
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

Anxiety; Cancer; Central venous catheter; Child; Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Heart Rate

  5 MONTHS

• Oxygen Saturation

  5 MONTHS

Study Arms (2)

Kaleidoscope Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

kaleidoscope application BEHAVIORAL

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.

Kaleidoscope Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• a cancer diagnosis,
• having a central venous catheter,
• 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.

You may not qualify if:

• the reporting of pain for another reason at the time of the central venous catheter dressing.

Sponsors & Collaborators

• Mehmet Akif Ersoy University: lead

Study Sites (1)

Pınar BEKAR

Burdur, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35248915 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Emine EFE, Prof.Dr.

  Akdeniz University, Department of Child Health and Disease Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: January 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)