NCT06933303: DISTRACT

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

Recruiting now NA Last updated 18 April 2025

What this trial tests

NA trial testing Distraction with kaleidoscope in Pain, Acute in 126 participants. Currently enrolling.

Timeline

30 March 2025

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Vrinnevi Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	126
Start date	30 March 2025
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across South Africa

Drugs / interventions tested

• Distraction with kaleidoscope

Conditions studied

• Pain, Acute — all drugs for Pain, Acute →

Sponsor

Vrinnevi Hospital

Who can join

Adults 7 to 12, any sex, with Pain, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.