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Distraction as Treatment for Pain in Children in Resource-scarce Settings

RecruitingNAAges 7 Years - 12 YearsAllVrinnevi Hospital
NCT06933303 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pediatric patients between the age of 7 and 12 years old with burn injuries requiring dressing changes in the outpatient clinic, who in regular practice (non-research setting) would not receive any analgesics; * Type of burn injury: partial thickness burns with a burned area not greater than 10% at the moment of the first dressing change measurement as part of this research Exclusion Criteria: * Patients who received split skin grafts for their burns; * Patients on sedatives or anti-epileptics; * The use of pain-relieving medication other than paracetamol or ibuprofen; * Painful additional injuries other than the burn injury; * Patients who are nursed in isolation; * Physical or mental impairments which make it impossible to adequately comply with the trial protocol. For example, visual impairments, impaired ability to communicate, psychological comorbidities, and burns that limit the use of a kaleidoscope (facial burns or burns to both hands); * Retrospective exclusion if the patient in the intervention group did not look through the kaleidoscope for more than 50% of the procedure time.
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What it tests

  • Distraction with kaleidoscope
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Where

1 site
Ngwelezana Hospital
Empangeni, South Africa
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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