An interventional study of Distraction with kaleidoscope in Pain, Acute, sponsored by Vrinnevi Hospital. Recruiting at 1 site in South Africa. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by Vrinnevi Hospital · Not applicable, Interventional, and Supportive care
Pain alleviation in pediatric patients can be challenging for medical professionals working in resource scarce settings due to limited availability of medication, monitoring equipment, or training in this field of expertise. This poses the need for a readily available tool for pain reduction that does not rely on expensive equipment or medication and which can easily be applied in resource scarce settings around the world. With this research project we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method: a kaleidoscope, to reduce acute pain in pediatric patients undergoing dressing changes in resource scarce environments.
A randomized controlled trial will be performed at the Edendale Hospital in Pietermaritzburg KwaZulu Natal, South Africa. Pediatric patients between the age of 7-12 years with partial thickness burn injuries who require dressing changes in the outpatient clinic will be randomized into two groups: one group (control) will receive standard practice of care which concerns a dressing change without any pain alleviation other than paracetamol or a non-steroidal anti inflammatory drug (NSAID), and one group (intervention) will receive distraction by use of a kaleidoscope as method for potential pain alleviation on top of standard medical care. The primary outcome will be the difference in mean change in pain score (from before to during the dressing change) between the control and distraction group.
This study is expected to demonstrate that the use of a non-electronic distraction technique effectively alleviates pain in children undergoing dressing changes and that its use is feasible in low resource settings. The distraction technique can be applied as add-on to pharmacological treatment, or stand-alone when no pharmacological treatment is available. Distraction is expected to be safe and can even be applied by an accompanying parent, resulting in lower barriers for healthcare workers to apply it. Appropriate pain relief will improve psychological wellbeing of pediatric patients undergoing painful procedures, and it might even improve recovery and physical rehabilitation since pain has been associated with physical as well as mental morbidity.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's planned enrollment of 126 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Vrinnevi Hospital is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Undergoing dressing change with standard medical care. Standard medical care can include: no pain alleviation methods; paracetamol; non-steroidal anti-inflammatory drug; combination of paracetamol with non-steroidal anti-inflammatory drug
Undergoing dressing change with standard medical care (as described above for Control arm), combined with distraction by use of a kaleidoscope as a possible pain alleviation method.
Device: Distraction with kaleidoscope
During the intervention measurement, the pediatric patient will be distracted by the use of a kaleidoscope during the procedure. Distraction by use of the kaleidoscope will be initiated at the start of the procedure (dressing change) and the kaleidoscope will be offered until at least a minute after the procedure is completed. Removal of the dressing will be started when the child seems distracted as indicated by response with a smile or laughter, or a verbal response
Change in pain score
The change (increase) in pain scores (the Wong-Baker FACES Pain Rating Scale and the FLACC scale), 0 (less pain)-10 (more pain) , from prior to the dressing change to during the dressing change
Time frame: Pain scores measured five minutes prior to dressing change; pain score during dressing change, measured immediately after removal of the dressing
Postprocedural pain score decrease
Change in mean pain scores (the Wong-Baker FACES Pain Rating Scale and the FLACC scale), 0 (less pain)-10 (more pain) , when comparing scores during with scores after the procedure.
Time frame: Pain scores during dressing change, after removal of the dressing; pain score at five minutes after dressing change
Heart rate
Change/course of heart rate before, during and after dressing change
Time frame: Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change
Oxygen saturation
Change/course of blood oxygen levels before, during and after dressing change
Time frame: Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change
Global satisfaction
Global judgement of satisfaction with treatment by caregiver and medical professional, will be measured on a 1 (very dissatisfied)-5 (very satisfied) scale based on the question: "Considering pain relief, side effects, and emotional status, how satisfied were you with the dressing change the child underwent?"
Time frame: Five minutes after dressing change
Procedure time
Procedure time (seconds), reflecting procedure efficiency/patient cooperation
Time frame: Duration of dressing change
Plan to share: No
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