Distraction As Multimodal Pain Management for Children in Resource-constrained Settings (DISTRACT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 126
- 主要终点
- The difference in patient-reported pain score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking for allocation. After allocation, there is no possibility for blinding the intervention.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
The difference in patient-reported pain score
时间窗: 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.
次要结局
- Observational pain score(During the dressing change procedure (0 minutes to 5 minutes))
- Global satisfaction with treatment(After dressing change (within 10 minutes))