Development and Validation of Clinical Practice Standards for Physical Restraint in Hospitalized Patients: A Multi-Method Study.

Background: Physical restraint is commonly used in clinical settings to ensure patient safety, yet its application lacks standardization and may lead to adverse physical and psychological effects. There remains a significant gap in evidence-based guidelines tailored to nurses practices. Objective: This study aimed to develop and validate clinical practice standards for physical restraint in hospitalized patients from a nurses staff perspective and to evaluate their impact on nurses knowledge, attitude, behaviors, and patient outcomes. Methods: A multi-stage design was employed, including a cross-sectional survey, semi-structured interviews, a Delphi expert consultation, and a controlled trial. The study involved 202 nurses and 100 patients from a tertiary hospital in Chongqing, China. The intervention group received standardized training based on the newly developed restraint criteria, while the control group followed routine protocols. Results: The expert consultation achieved high consensus (Cr = 0.85). Post-training, the intervention group showed significant improvements in knowledge, attitude, and practice scores (P < 0.05), and a reduction in restraint use and duration (P < 0.05). Although adverse event rates decreased in the intervention group, the differences were not statistically significant. Conclusion: The developed standards effectively enhance nurses practice, reduce unnecessary restraint use, and maintain patient safety, supporting their integration into clinical nurses management.