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

Not Applicable

Recruiting

• Conditions: Pain, Acute

• Registration Number: NCT06933303
• Lead Sponsor: Vrinnevi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-30
• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in pain score	Pain scores measured five minutes prior to dressing change; pain score during dressing change, measured immediately after removal of the dressing	The change (increase) in pain scores (the Wong-Baker FACES Pain Rating Scale and the FLACC scale), 0 (less pain)-10 (more pain) , from prior to the dressing change to during the dressing change

Secondary Outcome Measures

Name	Time	Method
Postprocedural pain score decrease	Pain scores during dressing change, after removal of the dressing; pain score at five minutes after dressing change	Change in mean pain scores (the Wong-Baker FACES Pain Rating Scale and the FLACC scale), 0 (less pain)-10 (more pain) , when comparing scores during with scores after the procedure.
Heart rate	Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change	Change/course of heart rate before, during and after dressing change
Oxygen saturation	Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change	Change/course of blood oxygen levels before, during and after dressing change
Global satisfaction	Five minutes after dressing change	Global judgement of satisfaction with treatment by caregiver and medical professional, will be measured on a 1 (very dissatisfied)-5 (very satisfied) scale based on the question: "Considering pain relief, side effects, and emotional status, how satisfied were you with the dressing change the child underwent?"
Procedure time	Duration of dressing change	Procedure time (seconds), reflecting procedure efficiency/patient cooperation

Trial Locations

Locations (1)

Ngwelezana Hospital; 🇿🇦 Empangeni, Kwazulu Natal, South Africa