Clinical trial · Interventional
Distraction As Multimodal Pain Management
Distraction As Multimodal Pain Management for Children in Resource-constrained Settings (DISTRACT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A randomized controlled trial will be performed at the Ngwelezana Hospital, Empangeni, South Africa. Paediatric patients between the age of 5-12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomized into two groups: the control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, sub analyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis. This will be correlated with care giver and health care worker observational pain scores.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burns | — | UNRESOLVED | — |
| Pain, Acute | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Distraction by use of kaleidoscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Distraction
- description
- The intervention group will undergo a dressing change procedure with distraction by use of a kaleidoscope as additional method for pain alleviation. In both groups, patients will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol.
- interventionNames
- Device: Distraction by use of kaleidoscope
- type
- NO_INTERVENTION
- label
- Control
- description
- The control group will undergo the standard dressing change procedure without additional distraction methods. In both groups, patients will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol.
Primary outcomes (1)
- measure
- The difference in patient-reported pain score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Pediatric patients between the age of 5 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 other than paracetamol or a non-steroidal anti-inflammatory drug (NSAID); * Superficial partial thickness burns \< 5% TBSA (total body surface area) at the time of injury * Only the first change of dressing is included Exclusion Criteria: * Patients who underwent split skin grafts for their burns; * Patients on sedatives or anti-epileptics; * The use of pain-relieving medication other than paracetamol or NSAIDs; * If it is the patient's second presentation to Ngwelezana hospital's outpatient burns department * Painful additional injuries other than the burn injury; * 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)
References
Publications (1)
- DERIVEDHaverkamp FJC, Naidoo R, Muhrbeck M, Pompermaier L, Wladis A, van Laarhoven CJHM, Tan ECTH. DISTRACT study: evaluating kaleidoscope distraction as part of multimodal pain management in paediatric dressing changes - study protocol of a single centre randomised trial. BMJ Open. 2025 Jul 28;15(7):e093761. doi: 10.1136/bmjopen-2024-093761. PMID 40721257