Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care (SNOEZELEN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 2
研究概览
简要总结
This is a monocentric, comparative, open-label, randomized, crossover study enrolling patients hospitalized in Strasbourg Europe Cancerology Institute, receiving repeated invasive care for cancer treatment.
The purpose of this study is to compare the satisfaction of patients, regarding their perception of care, with or without Snoezelen session.
详细描述
Patients will followed during two visits for a repeated invasive care. They will be randomized to two groups in a 1:1 ratio.
Crossover plan and arms are described as follow:
Arm A : Visit 1 with Snoezelen session before invasive care and Visit 2 without Snoezelen session before invasive care (standard care)
Arm B : Visit 1 without Snoezelen session before invasive care (standard care) and Visit 2 with Snoezelen session before invasive care
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated for cancer and hospitalized for invasive care
- •Two programmed hospitalization for repeated care
- •Patients receiving one of the following invasive care: Huber needle application (transfusion, parenteral nutrition), complex wound dressing, intrathecal chemotherapy, ascites fluid or pleural puncture
- •Patients must be ≥ 18 years old
- •Performance Status ≤ 3
- •Absence of psychiatric disorder impairing follow-up
- •Ability to speak, understand, write and read French
- •Signed informed consent from the patient
- •Affiliation to social security system
排除标准
- •Patients presenting infectious symptoms requiring isolation
- •Patients < 18 years old or patients ≥ 18 years old under supervision
- •Patients placed under judicial protection or guardianship
- •Women that are pregnant or breast-feeding
结局指标
主要结局
Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 2
时间窗: immediately after invasive care at Visit 2
Evaluation using a modified Visual Analog Scales, Oberts, 1984
Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 1
时间窗: immediately after invasive care at Visit 1
Evaluation using a modified Visual Analog Scales, Oberts, 1984
次要结局
- Change in patient perceived pain, with or without Snoezelen session(At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°1; At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°2)
- Comparing relationship between patient and caregiver, with or without Snoezelen session(immediately after invasive care at Visit 1 ; immediately after invasive care at Visit 2)
- Change in patient perceived anxiety, with or without Snoezelen session(At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°1; At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°2)