Actively Recruiting
Distraction as Treatment for Pain in Children in Resource-scarce Settings
Led by Vrinnevi Hospital · Updated on 2025-04-18
126
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
V
Vrinnevi Hospital
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Distraction as Treatment for Pain in Children in Resource-scarce Settings
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients aged 7 to 12 years with burn injuries requiring dressing changes in an outpatient clinic
- Partial thickness burns with burned area not greater than 10% at first dressing change
- Patients who would not normally receive analgesics in regular care
You will not qualify if you...
- Patients who have received split skin grafts for their burns
- Patients taking sedatives or anti-epileptics
- Use of pain-relieving medication other than paracetamol or ibuprofen
- Presence of painful injuries other than the burn injury
- Patients nursed in isolation
- Physical or mental impairments preventing trial compliance, including visual impairments, communication difficulties, psychological conditions, or burns preventing kaleidoscope use (e.g., facial or both hands burns)
- Retrospective exclusion if kaleidoscope was used less than 50% of procedure time in intervention group
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ngwelezana Hospital
Empangeni, KwaZulu-Natal, South Africa, 3880
Actively Recruiting
Research Team
M
Måns Muhrbeck Senior surgical consultant, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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