Distraction As Multimodal Pain Management

NCT ID: NCT06591195

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2026-10-31

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.

Conditions

Pain, Acute; Burns; Pediatric ALL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Distraction

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.

Group Type: EXPERIMENTAL

Distraction by use of kaleidoscope

Intervention Type: DEVICE

À kaleidoscope is an optical device consisting of mirrors that reflect images of bits of coloured glass in a symmetrical geometric design through a viewer.

A kaleidoscope was selected as the non-electronic method of distraction, because of its wide availability due to low costs, its evolving and colourful visual stimuli, the fact that is blocks out any visualisations from the environment when used properly, and because it requires active participation (i.e., greater attention) from the subject.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Distraction by use of kaleidoscope

À kaleidoscope is an optical device consisting of mirrors that reflect images of bits of coloured glass in a symmetrical geometric design through a viewer.

A kaleidoscope was selected as the non-electronic method of distraction, because of its wide availability due to low costs, its evolving and colourful visual stimuli, the fact that is blocks out any visualisations from the environment when used properly, and because it requires active participation (i.e., greater attention) from the subject.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ravi Naidoo, MD

Role: PRINCIPAL_INVESTIGATOR

General surgeon, head of Burns Unit at Ngwelezana Hospital, Empangeni, South Africa

Central Contacts

Ravi Naidoo, MD

Role: CONTACT

ravi@drnaidoo.co.za

0027 35 9017000

Frederike Haverkamp, MD, PhD

Role: CONTACT

frederike.haverkamp@radboudumc.nl

0031243610492

References

Haverkamp 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.

Reference Type: DERIVED

PMID: 40721257 (View on PubMed)

Other Identifiers

BREC/00005194/2023

Identifier Type: -

Identifier Source: org_study_id