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

NCT ID: NCT04924023

Last Updated: 2021-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-05-31

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.

Conditions

Pain; Anxiety

Keywords

Anxiety; Cancer; Central venous catheter; Child; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Kaleidoscope Group

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.

Group Type: EXPERIMENTAL

kaleidoscope application

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mehmet Akif Ersoy University

OTHER

Sponsor Role: lead

Responsible Party

Pınar BEKAR

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emine EFE, Prof.Dr.

Role: STUDY_DIRECTOR

Akdeniz University, Department of Child Health and Disease Nursing

Locations

Pınar BEKAR

Burdur, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 35248915 (View on PubMed)

Other Identifiers

KAEK-791

Identifier Type: -

Identifier Source: org_study_id