School of Nursing, Ningxia Medical University, 1160 Sheng Li Street, Yinchuan, 750004, China.
Department of Geriatric Medicine and Special Medical, Ningxia Medical University General Hospital, 804 Sheng Li South Street, Yinchuan, 750004, China.
Trials. 2022 May 14;23(1):404. doi: 10.1186/s13063-022-06326-5.
Common and frequent as acute pain is, it is often underestimated and undertreated in older people with dementia in nursing homes and inadequate pain management remains an issue.
The study is designed to be a randomized, sham-controlled trial and is underway in nursing homes located in China. A total of 206 dementia patients are being recruited from nursing homes in Yinchuan, China. They are randomly allocated to an intervention or a controlled group in a 1:1 ratio. The intervention group will be treated with true APP therapy, while the other group will receive APP at sham point stimulation therapy. The patients will be assessed at baseline (T0), at 5 min during performing the intervention (T1), and at 5 min after completion of the intervention (T2). The primary outcome is the level of pain relief at T1 and T2. Physiological parameters, side effects and additional use of analgesics during the procedure, satisfaction from caregivers, and acceptance of patients are evaluated as secondary outcomes.
The results of this study are expected to verify the analgesic effect of APP for acute pain in patients with mild dementia in nursing homes. It has the potential to prompt APP therapy to be implemented widely in dementia patients with acute pain in nursing homes.
Chinese Clinical Trial Registry ChiCTR2100047932 . Registered on 27 June 2021. Currently, patient recruitment is ongoing. Recruitment is expected to take place from December 2020 to December 2021.
急性疼痛虽然常见且频繁，但在养老院中患有痴呆症的老年人中往往被低估和治疗不足，且疼痛管理不足仍然是一个问题。
该研究旨在设计为一项随机、假对照试验，正在中国的养老院中进行。共有 206 名痴呆症患者从中国银川的养老院招募。他们以 1:1 的比例随机分配到干预组或对照组。干预组将接受真实 APP 治疗，而另一组将接受 APP 在假穴位刺激治疗。患者将在基线（T0）、干预期间的 5 分钟（T1）和干预完成后的 5 分钟（T2）进行评估。主要结局是 T1 和 T2 时的疼痛缓解程度。评估生理参数、副作用以及在治疗过程中额外使用镇痛药、护理人员的满意度和患者的接受度作为次要结局。
预计该研究的结果将验证 APP 对养老院中轻度痴呆症患者急性疼痛的镇痛效果。它有可能促使 APP 疗法在养老院中患有急性疼痛的痴呆症患者中广泛实施。
中国临床试验注册中心 ChiCTR2100047932 。注册于 2021 年 6 月 27 日。目前正在招募患者。预计招募时间为 2020 年 12 月至 2021 年 12 月。
