Clinical trial NCT06933303: Distraction as Treatment for Pain in Children in Resource-scarce Settings
Official title: Distraction as Treatment for Pain in Children in Resource-scarce Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Acute
Keywords: Distraction
Pain
Burn injury
Dressing change
Pediatric
Lead sponsor: Vrinnevi Hospital
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: Linkoeping University
name: University of KwaZulu
First posted: 2025-04-18
Enrollment: 126
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain score
timeFrame: Pain scores measured five minutes prior to dressing change; pain score during dressing change, measured immediately after removal of the dressing
Secondary outcomes:
measure: Postprocedural pain score decrease
timeFrame: Pain scores during dressing change, after removal of the dressing; pain score at five minutes after dressing change
measure: Heart rate
timeFrame: Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change
measure: Oxygen saturation
timeFrame: Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change
measure: Global satisfaction
timeFrame: Five minutes after dressing change
measure: Procedure time
timeFrame: Duration of dressing change
Other outcomes:
Locations:
city: Empangeni
country: South Africa
facility: Ngwelezana Hospital
state: Kwazulu Natal
Study officials:
References: