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

NCT06933303 | Recruiting

• 1 other identifier: DISTRACT-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute

Keywords

Distraction; Pain; Burn injury; Dressing change; Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postprocedural pain score decrease

  Pain scores during dressing change, after removal of the dressing; pain score at five minutes after dressing change

• Heart rate

  Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes 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

• Global satisfaction

  Five minutes after dressing change

• Procedure time

  Duration of dressing change

Study Arms (2)

Control

NO INTERVENTION

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

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

Interventions

Distraction with kaleidoscope DEVICE

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

Distraction

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• Vrinnevi Hospital: lead
• Radboud University Medical Center: collaborator
• Linkoeping University: collaborator
• University of KwaZulu: collaborator

Study Sites (1)

Ngwelezana Hospital

Empangeni, KwaZulu-Natal, 3880, South Africa

RECRUITING

MeSH Terms

Conditions

Acute Pain; Pain; Burns

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Central Study Contacts

Måns Muhrbeck Senior surgical consultant, MD, PhD

CONTACT

46-703338852; mans.muhrbeck@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 18, 2025
• Study Start: March 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)