Prevention of Pain Induced During Bed Bath in Ehpad, by Adapted Mobilization Techniques : A Single Case Experimental Design (ABAB) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pain reduction with ALGOPLUS
研究概览
简要总结
Residents of long-term care facilities are subjected to procedures and treatments that may be painful. The prevalence is 90% among older adults living in institutions. Preventing procedure-induced pain is essential, as the consequences can be even more harmful. Induced pain is defined as "short-term pain caused by a healthcare provider, treatment, or care, under predictable circumstances," according to the UPSA Pain Institute.
For these older adults, personal hygiene is performed in bed by nursing assistants and requires frequent handling and repositioning. It includes dressing and undressing, which are sources of pain. Despite this, these activities are repeated daily because they are essential. Addressing pain is a fundamental criterion for quality of life in older adults.
In many cases, these residents require daily premedication with analgesics to prevent pain caused by personal care. For these residents, who are already on multiple medications, the addition of analgesics increases the risk of drug interactions, leading to more frequent side effects.
详细描述
For residents who meet the eligibility criteria, a member of the research team-including the physician and the psychomotor therapist-meets with the resident to inform them about the study and obtain their verbal consent, if possible. If the resident is unable to give consent, the information is provided to the family or a trusted representative by phone or during a visit to the nursing home. The representative may ask the care team any questions and give oral consent after sufficient time to consider the matter.
If consent is given, the resident is then enrolled and randomized into the study.
Randomization will be based on the number of days in the first week (5, 6, or 7 days) and will be performed by the investigator in the eCRF.
The psychomotor therapist will provide expertise that the nursing assistants (NAs) will need to apply during their daily care routines throughout the pilot period in order to make care sessions less unpleasant and painful for the residents.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria common to all groups
- •Senior residents
- •With a stable Algoplus score of 2 or higher
- •Information provided to and consent obtained from the resident or their trusted representative
- •Eligible for intervention by a psychomotor therapist
- •Criteria specific to Group 1:
- •Residents requiring high doses of analgesics (Level 3) before bathing
- •GIR (Iso-Resource Group) 1, with multiple medical conditions
- •Criteria specific to Group 2:
- •Residents requiring Level 1 or 2 analgesics before bathing
- •GIR (Iso-Resource Group) 2 or 3, with multiple medical conditions
- •Criteria specific to Group 3:
- •Residents experiencing pain without analgesics prior to bathing
- •GIR (Iso-Resource Group) 3 or 4, with multiple medical conditions
排除标准
- •Resident who has previously received treatment from a psychomotor therapist
- •Resident capable of washing at the sink (partially) or independently
- •Under guardianship, conservatorship, or judicial protection
研究组 & 干预措施
Resident GIR1
Resident (GIR (Iso-Resource Group) 1) requiring high doses of pain medication (Level 3) before bathing
干预措施: Standard personal hygiene (Other)
Resident GIR1
Resident (GIR (Iso-Resource Group) 1) requiring high doses of pain medication (Level 3) before bathing
干预措施: Adapted toilet (Other)
Resident GIR 2-3
Residents (GIR (Iso-Resource Group) 2 or 3) who require Level 1 or 2 analgesics before bathing
干预措施: Standard personal hygiene (Other)
Resident GIR 2-3
Residents (GIR (Iso-Resource Group) 2 or 3) who require Level 1 or 2 analgesics before bathing
干预措施: Adapted toilet (Other)
Resident GIR 3-4
Residents (GIR (Iso-Resource Group) 3 or 4 ) without analgesics before bathing
干预措施: Standard personal hygiene (Other)
Resident GIR 3-4
Residents (GIR (Iso-Resource Group) 3 or 4 ) without analgesics before bathing
干预措施: Adapted toilet (Other)
结局指标
主要结局
Pain reduction with ALGOPLUS
时间窗: 4 weeks
Pain measured using the ALGOPLUS scale by one independent evaluator (an experienced medical or paramedical professional) after bathing.
次要结局
- Bathing Process(4 weeks)
- Drug profile(4 weeks)
- Satisfaction of care workers(4 weeks)