Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The scars of children with burns
研究概览
简要总结
The goal of this clinical trial is to compare tele-rehabilitation and routine post-discharge rehabilitation in children with burn injuries. The main questions it aims to answer are:
- Is tele-rehabilitation better for improving the quality and outcomes of care for burn children?
- Is tele-rehabilitation more effective in improving scar management in children with burns injuries?
- Is tele-rehabilitation more effective in improving perceived stress in parents of children with burns injuries?
详细描述
In this study, experimental group received a 12-week tele-rehabilitation program, which included face-to-face access to silicone pads, pressure garments, splint and other tools necessary for burn recovery. The tele-rehabilitation program was used for intervention and regular follow-up.
The control group also received a 12-week follow-up, but only on the basis of face-to-face access to silicone pads, pressure garments, splint and other tools necessary for burn recovery.
Researchers will compare whether the trial group has better the quality and outcomes of care and scarring for children and parents who perceived stress.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria are based on the recommendations of the American Burn Association.
- •Child suffered from burn injury 3-6 years old and had survived the burn event.
- •The burn severity quantified by the total body surface area（TBSA）burned is equal or more than 1%.
- •TBSA burned is the estimated proportion of the body with second or third degree burns.
- •Burns involving neck, trunk，limbs and face.
- •Only Chinese parents will be recruited.
排除标准
- •1.Insufficient parental Chinese language proficiency required to complete questionnaires.
- •Parents cannot use social software (such as WeChat, QQ, etc.) for video, picture, and text communication after discharge.
- •The main caregiver is someone other than the parents.
- •Children did not live at home with their parents, such as hospitalization, boarding school, etc.
- •Children who are receiving rehabilitation treatment.
- •Children who have other severe disease, like cerebral palsy.
结局指标
主要结局
The scars of children with burns
时间窗: baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)
Ultrasound assessment of scar thickness, The DermaLab Combo assessment of scar Transepidermal Water Loss (TEWL), pigmentation, hydration and elasticity. The normal skin thickness is about 0.07-1.2mm, while the thickness of hypertrophic scars increases with the severity. The DermaLab Combo® (Cortex Technologies, Denmark) is a commercially available skin testing device. It is a high-specification device based on proven technologies. It is an easy to use and commercially available device, making it a viable option for scar assessment in both clinical and research settings. The worse the scar condition, the greater the Transepidermal Water Loss (TEWL), the darker the pigmentation (the larger the value), the smaller the hydration, and the smaller the elasticity (the larger the value).
The quality and outcomes of care for burn children
时间窗: baseline , 4 weeks, 8 weeks, and 12 weeks (post-test)
The health outcomes burn questionnaire (HOBQ) for infants and children 6 years of age and younger is developed by American Burn Association/Shriners Hospitals for Children. The HOBQ has a total of 55 items, calculated on a hundred-point scale, the higher the score, the better. Consists of 10 subscale, and each item is also converted into a percentage system. For the same score, the higher the better. There are 5 items for play, 4 items for language, 7 items for fine motor skills, 7 items for gross motor skills, 9 items for behavior, 5 items for family, 7 items for pain/itching, 3 items for appearance, 5 items for satisfaction, and 3 items for concern/worry. The number of items per scale ranges from two to nine. All subscales relate to the past month,except the subscale 'satisfaction'. The questionnaire has been translated into Chinese, and the reliability and validity of its Chinese version have also been confirmed.
次要结局
- psychological stress of caregvers(baseline , 4 weeks, 8 weeks, and 12 weeks (post-test))
研究者
LIAO Peng
Mr.
The Hong Kong Polytechnic University