Actively Recruiting

Phase Not Applicable
Age: 7Years - 12Years
All Genders
NCT06933303

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

Age: 7Years - 12Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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