Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Situations identified by 2 standard deviation increase in HR
研究概览
简要总结
The overarching aim is to generate knowledge to reduce incidence of pain in non-verbal patients' everyday life. The trial will 1) evaluate how HR can be used to identify potentially painful care procedures that should be re-evaluated in terms of the approach taken; 2) test the effect of heart rate (HR)-informed changes in potentially painful care procedures on biomarkers of pain, and 3) assess how six weeks of communication through HR affects the quality of communication between patient and caregiver.
详细描述
Detailed protocol to be published as journal article with reference to Clinicaltrials.gov-registration. Preprint available: https://osf.io/gan42
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the objectives of the study, the identity of test and control treatments will not be known when analysing data. Access to the randomization code will be strictly controlled.
入排标准
- 年龄范围
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 5 and 70 years of age at the time of data collection
- •Autism spectrum disorder as evaluated by clinical psychologist
- •Communication difficulties
- •Living at a care home with round-the-clock staff for at least five days a week; or attending one-to-one staffed school/day-care at least five days a week.
- •Written informed consent is obtained from the subjects' legal representative.
排除标准
- •Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.
研究组 & 干预措施
Control group
After 4 weeks mapping phase, patient-specific HR-informed intervention from week 5.
干预措施: Delayed HR-informed specific change in routine (Behavioral)
Intervention group
After 2 weeks mapping phase, patient-specific HR-informed intervention from week 3.
干预措施: HR-informed change in routine (Behavioral)
结局指标
主要结局
Situations identified by 2 standard deviation increase in HR
时间窗: 11 weeks
The hypothesis is that a 2 standard deviation increase in HR can identify potentially painful care situations that require re-evaluation. Mean HR spike counts will be compared using a one-tailed paired sampled t-test to differentiate between suitable and unsuitable situations for care adjustments.
次要结局
- HRV (ms)(6 weeks)
- Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml)(6 weeks)
- Scores on quality of communication(6 weeks)
研究者
Bjørnar Hassel
Professor
University of Oslo