Pediatric Patient Experience on a Diagnostic Path
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- State-Trait Anxiety Inventory for Children
研究概览
简要总结
The trial will determine the impact of an information- and education-focused interventions on the anxiety levels, and patients' experiences as well as satisfaction of patients aged 10-14 and their caregivers during the MR examination.
详细描述
The aims of the trial
-
Examining the level of anxiety of individuals undergoing magnetic resonance imaging (MRI) as patients or caregivers (anxiety is measured at two points: before and after the MRI procedure).
-
Examining subjective patients' and caregivers' assessments of the key factors which make up the Patient Experience, i.e. the sum of all interactions which influence perceptions of the patients and their caregivers. The Patient Experience in this sense includes what is perceived, understood and remembered by the patient and their relatives in terms of:
- access to services and resources
- coordination and safety
- effectiveness of the services
- communication and education
- patient empowerment
- respect and dignity
- ensuring physical wellbeing
- ensuring psychological wellbeing
- environment and comfort and consequent levels of satisfaction. The full set of factors will only be examined for the patients' caregivers, while for the patients themselves the set of factors will be limited to those which can be competently assessed by persons aged 10-14 years.
- Examining the extent to which education- and information-focused interventions, using a variety of media (information leaflets, educational video, demonstration with props), impact anxiety levels, individual elements of the experience, and patients' and caregivers' satisfaction levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 10-14 years.
- •Referred for magnetic resonance imaging due to clinical indications.
- •Patients undergoing magnetic resonance examination for the first time.
- •Possibility of cooperating with the patient during the examination, no need for sedation.
- •Consent of the patients' caregivers to participate in the examination; in the case of patients ≥ 13 years of age, also the patients' consents.
- •Absence of contraindications to magnetic resonance imaging
排除标准
- •Lack of parental or patient consent to participate in the trial.
- •Contraindications to undergo magnetic resonance imaging.
- •Lack of possibility to cooperate with the patient during the examination and/or the need for general anaesthesia for the MR examination.
结局指标
主要结局
State-Trait Anxiety Inventory for Children
时间窗: through study completion, an average of 1 year
Change in State-Trait Anxiety Inventory for Children score; minimum score=20, maximum score=60, higher scores mean a worse outcome
次要结局
- State-Trait Anxiety Inventory(through study completion, an average of 1 year)
研究者
Elżbieta Jurkiewicz
professor
Children's Memorial Health Institute, Poland