Distraction As Multimodal Pain Management

Официальное название

Distraction As Multimodal Pain Management for Children in Resource-constrained Settings (DISTRACT)

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• The difference in patient-reported pain score [Срок оценки: Baseline, before wound cleaning (0 minutes) and after dressing change (within 10 minutes)]

Вторичные конечные точки (2)

• Observational pain score [Срок оценки: During the dressing change procedure (0 minutes to 5 minutes)]
• Global satisfaction with treatment [Срок оценки: After dressing change (within 10 minutes)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 40721257

Идентификаторы

NCT: NCT06591195 · BREC/00005194/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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