Distraction as Treatment for Pain in Children in Resource-scarce Settings (DISTRACT)

Vrinnevi Hospital

Status: Enrolling

Conditions: Pain, Acute

Treatments: Device: Distraction with kaleidoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT06933303

DISTRACT-01

Details and patient eligibility

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Control

No Intervention group

Description:

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

Distraction

Experimental group

Description:

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.

Treatment:

Device: Distraction with kaleidoscope