Distraction As Multimodal Pain Management (DISTRACT)

Radboud University Medical Center

Status: Not yet enrolling

Conditions: Pain, Acute; Pediatric ALL; Burns

Treatments: Device: Distraction by use of kaleidoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT06591195

BREC/00005194/2023

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

126 participants in 2 patient groups

Distraction

Experimental group

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.

Treatment:

Device: Distraction by use of kaleidoscope

Control

No Intervention group

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.