Distraction As Multimodal Pain Management

Not Applicable

Not yet recruiting

• Conditions: Pain, Acute; Burns; Pediatric ALL
• Interventions: Device: Distraction by use of kaleidoscope

• Registration Number: NCT06591195
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Study Start: 2024-10
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 126

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distraction	Distraction by use of kaleidoscope	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.

Primary Outcome Measures

Name	Time	Method
The difference in patient-reported pain score	Baseline, before wound cleaning (0 minutes) and after dressing change (within 10 minutes)	The patient-reported pain score after the dressing change minus the pain score before the procedure. This pain score is rated on the Wong-Baker FACES Pain Rating Scale from 0-10.

Secondary Outcome Measures

Name	Time	Method
Observational pain score	During the dressing change procedure (0 minutes to 5 minutes)	The observational pain score is measured during the dressing change on the Face, Legs, Activity, Cry and Consolability (FLACC) scale from 0 to 10. This score is corrected by the baseline (patiënt-reported) pain score before the dressing change.
Global satisfaction with treatment	After dressing change (within 10 minutes)	Global satisfaction about the treatment is assessed among the patient's caregiver and healthcare provider. Global satisfaction will be rated on a 1-5 scale based on the question: "Considering pain relief, side effects, and emotional status, how satisfied were you with the dressing change your child underwent?\"