Research Project on the Risk of Discomfort, Pain and Alteration of Skin Condition in Bedpan Use by Patients and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan.
研究概览
简要总结
The hypothesis is that the current bedpan is not adapted to the diversity of patients encountered. It is necessary to collect the opinions of patients themselves on the current pool in different departments in order to validate our hypothesis.
The objective is to evaluate pain in patients with reduced or very reduced mobility caused by the bedpan currently used in current practice through an observational study.
详细描述
Patients with reduced or severely reduced mobility, over 18 years of age, bedridden and requiring the use of a bedpan, estimated hospitalization equal to or greater than 2 days on the ward.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient of legal age (age ≥ 18 years).
- •Patient with reduced and very reduced mobility, bedridden requiring the use of a bedpan.
- •Estimated length of hospital stay on the ward ≥ 2 days.
- •Patient affiliated to a social security system.
- •Patient able to understand the protocol.
- •Patient having given oral non-opposition to participate.
- •Patient who has received the study information note.
- •Patient who had never participated in this study.
排除标准
- •Patients with cognitive impairment preventing objective pain assessment or with neurological pathologies.
- •Patients under guardianship, curatorship or safeguard of justice.
结局指标
主要结局
Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan.
时间窗: Four assessments in 48 hours
Pain will be assessed using a numerical pain scale (EN). The caregiver will ask the patient to rate his or her pain between 0 (no pain) and 10 (the most intense pain imaginable).
次要结局
- Assess alteration of skin condition at the seat of the patient using the bedpan(48 hours)
- Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan.(48 hours)
- Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort(48 hours)
- Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3(48 hours)
- Assess patient discomfort on the bedpan(48 hours)
- Assess the risk factors associated with the onset of pain when placing a bedpan.(48 hours)
- Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan.(48 hours)
- Assess the difficulty of positioning and removing the bedpan.(48 hours)
- Assess bedpan stability during use(48 hours)