Clinical trial NCT04924023: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: Anxiety
Cancer
Central venous catheter
Child
Pain
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Wong-Baker FACES Pain Rating Scale (WB-FACES)
timeFrame: 5 MONTHS
measure: Children's Fear Scale (CFS)
timeFrame: 5 MONTHS
Secondary outcomes:
measure: Heart Rate
timeFrame: 5 MONTHS
measure: Oxygen Saturation
timeFrame: 5 MONTHS
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Pınar BEKAR
Study officials:
affiliation: Akdeniz University, Department of Child Health and Disease Nursing
name: Emine EFE, Prof.Dr.
role: STUDY_DIRECTOR
References:
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.