关键词: 重症监护室；身体约束；质量标准；阶梯设计整群随机对照试验

Abstract: Objective: To establish a graded physical restraint nursing quality standard for ICU and conduct training to ICU nurses, to provide references for standardizing graded physical restraint nursing practices. Methods: From July to December 2023, a Stepped Wedge Cluster Randomized Trial was conducted among 346 ICU nurses across 4 tertiary grade A hospitals in 4 cities in Fujian province. Using a cluster sampling approach, ICU nurses in 4 hospitals were sequentially randomized into 4 groups according to the stepped wedge design. Nurses in the control group received training based on the conventional physical restraint nursing quality standard, while those in the intervention group were trained according to the graded physical restraint nursing quality standard for the ICU. Evaluations included scores on the ICU Graded Physical Restraint Nursing Assessment Questionnaire, as well as the number of non-compliant items in physical restraint quality checks, physical restraint rate, duration of graded physical restraint, distribution of restraint levels, incidence of restraint-related complications, and unplanned extubation rate. Results: After training, the intervention group showed improved assessment scores and a reduction in non-compliant items during physical restraint quality checks. The physical restraint rate and the duration of grade Ⅲ and Ⅳ physical restraints were lower in the intervention group compared to the control group. Differences in physical restraint levels were also observed across intervention phases (P<0.05). There was no statistically significant difference in the incidence of physical restraint-related complications between the two groups (P>0.05), and no unplanned extubation events occurred in either group. Conclusion: The establishment, training and application of the ICU graded physical restraint nursing quality standard helpes ICU nurses to develop an awareness of the need to accurately assess the level of physical restraint and to manage the quality of lean physical restraint.

Key words: ICU; physical restraint; quality standard; Stepped Wedge Cluster Randomized Trial