Clinical trial NCT06591195: Distraction As Multimodal Pain Management
Official title: Distraction As Multimodal Pain Management for Children in Resource-constrained Settings (DISTRACT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Acute
Burns
Pediatric ALL
Keywords: Distraction
Pain treatment
Pediatric burn injury
Dressing change
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 126
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: The difference in patient-reported pain score
timeFrame: Baseline, before wound cleaning (0 minutes) and after dressing change (within 10 minutes)
Secondary outcomes:
measure: Observational pain score
timeFrame: During the dressing change procedure (0 minutes to 5 minutes)
measure: Global satisfaction with treatment
timeFrame: After dressing change (within 10 minutes)
Other outcomes:
Locations:
Study officials:
affiliation: General surgeon, head of Burns Unit at Ngwelezana Hospital, Empangeni, South Africa
name: Ravi Naidoo, MD
role: PRINCIPAL_INVESTIGATOR
References: