A Randomized Controlled Trial to Evaluate the Effectiveness of a mHealth Application as a Family Educational and Supportive Tool in Children Tonsillectomy and/or Adenoidectomy Perioperative Process Compared to Standard Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Between groups difference in preoperative primary child caregiver state anxiety (T2)
研究概览
简要总结
Tonsillectomy and/or adenoidectomy are common surgeries in children. Authors report how distressed children and their families are by perioperative processes. Fear of the unknown can put a strain on the preoperative period, while pain and other possible complications such as fever, vomiting, restricted oral feeding or bleeding can create difficulties in postoperative home management. Parental anxiety has been found to worsen the perception of pain, perioperative discomfort and recovery of operated children. Providing children and families with preparation for hospitalisation, surgery and postoperative home management has been shown to improve perioperative outcomes. However, not all individuals can understand and benefit from the information provided by healthcare professionals: higher levels of anxiety in the perioperative process have been associated with individuals with low health literacy. Furthermore, unmet information needs may lead parents to expose themselves to health-related misinformation through autonomous investigations on the Web and common social media resources. Patient- and family-centred education and support is a complex and time-consuming care practice, while some surgeries such as tonsillectomy are characterised by short hospitalisations that limit the amount of time health professionals can devote to this programme. Health systems have been testing different types of formats, content and ways of delivering health information/education in order to meet the requirements of clients, time availability and effectiveness. MHealth apps in particular are an essential element of e-health and consist of medical information that is available via mobile phones or other wireless devices and can be used by patients or health professionals. Their use is growing and evolving into a variety of functionalities and positive outcomes related to improving the wellbeing of individuals, including diagnostics and clinical decision-making; interventions on healthy behaviours and lifestyles; patient disease management and self-care. Findings from literature highlight the need for further randomised controlled trials to confirm positive results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregivers of children aged 2-10 scheduled for tonsillectomy and/or adenoidectomy with or without tympanostomy tubes insertion;
- •Caregivers who are capable of oral and written communication without any impairment;
- •Caregivers who guarantee access to a smartphone and internet connection.
排除标准
- •Caregivers with cognitive deficits;
- •Caregivers of children with cognitive impairment
- •Caregivers with visual impairment;
- •Caregivers of children affected by chronic pain;
- •Caregivers of children who had another surgery operation in the previous month.
- •Caregivers who never used at least one smart phone application
结局指标
主要结局
Between groups difference in preoperative primary child caregiver state anxiety (T2)
时间窗: 5 minutes before heading to the operating theatre
Differences between intervention and control groups in preoperative primary child caregiver state anxiety, measured through the State-Trait Anxiety Inventory form Y questionnaire (T2). The questionnaire consists of two self-report scales for measuring state anxiety and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how the respondent feels "now, at this moment," on a 4 items Likert scale, from "not at all" to "very much"; the T-Anxiety scale (STAI Form Y-2) consists of twenty statements that evaluate how the respondent feels "generally" on a 4-point Likert scale from "almost never" to "almost always". Total scores range from 20 to 80 points with lower scores indicate higher trait and state anxiety.
次要结局
- Between groups difference in preoperative children distress (T2)(5 minutes before heading to the operating theatre)
- Between groups difference in parents' preparation for hospitalization and surgery (T1)(Within 30 minutes after the admission in the surgery ward)
- Between groups difference in state anxiety assessment at post-operative follow up (T3)(7 days after surgery)
- Between groups difference in state anxiety from enrollment and preoperative evaluations (T0 vs T2)(5 minutes after enrolment / 5 minutes before heading to the operating theatre)
- Between groups difference in state anxiety from enrollment and post-operative follow up evaluations (T0 vs T3)(5 minutes after enrolment / 7 days after surgery)
- Between groups difference in the social and health impact of the introduction of an mHealth App(7 days after surgery)