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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Acute
• Intervention / Treatment: Device: Distraction with kaleidoscope

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Måns Muhrbeck Senior surgical consultant, MD, PhD; Phone Number: 46-703338852; Email: mans.muhrbeck@liu.se

Study Locations

• South Africa
  • Kwazulu Natal
    • Empangeni, Kwazulu Natal, South Africa, 3880
      • Recruiting
      • Ngwelezana Hospital
      • Contact: Ravi Naidoo, MD, PhD; Phone Number: +27359017000; Email: ravi@drnaidoo.co.za
      • Contact: Ravi Naidoo, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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
Experimental: Distraction; 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.	Device: Distraction with kaleidoscope; During the intervention measurement, the pediatric patient will be distracted by the use of a kaleidoscope during the procedure. Distraction by use of the kaleidoscope will be initiated at the start of the procedure (dressing change) and the kaleidoscope will be offered until at least a minute after the procedure is completed. Removal of the dressing will be started when the child seems distracted as indicated by response with a smile or laughter, or a verbal response

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain score	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	Pain scores measured five minutes prior to dressing change; pain score during dressing change, measured immediately after removal of the dressing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprocedural pain score decrease	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.	Pain scores during dressing change, after removal of the dressing; pain score at five minutes after dressing change
Heart rate	Change/course of heart rate before, during and after dressing change	Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change
Oxygen saturation	Change/course of blood oxygen levels before, during and after dressing change	Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change
Global satisfaction	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?"	Five minutes after dressing change
Procedure time	Procedure time (seconds), reflecting procedure efficiency/patient cooperation	Duration of dressing change

Collaborators and Investigators

• Sponsor: Vrinnevi Hospital
• Collaborators: Radboud University Medical Center; Linkoeping University; University of KwaZulu

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Pediatric; Distraction; Burn injury; Dressing change
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: DISTRACT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No