Effects of a Structured Early Rehabilitation Nursing Pathway on Gastrointestinal Recovery and Quality of Life in Severe Acute Pancreatitis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Incidence of Complications
研究概览
简要总结
This randomized controlled trial evaluates the clinical efficacy of a structured early rehabilitation nursing (ERN) pathway compared to routine care in patients with severe acute pancreatitis (SAP). The study aims to determine if the ERN pathway, which includes phased mobility, respiratory training, and psychological support, can improve gastrointestinal recovery, reduce hospital stay and complications, and enhance functional independence and quality of life.
详细描述
Severe acute pancreatitis (SAP) is a life-threatening condition with high mortality and morbidity, often complicated by prolonged immobilization, leading to muscle atrophy, delayed gut recovery, and increased infection risk. Current nursing practices often neglect early mobilization. This study introduced and tested a structured early rehabilitation nursing pathway (SERNP) designed to address these gaps. A total of 104 eligible SAP patients were randomly assigned to either the SERNP group (n=52) or a control group receiving routine care (n=52). The SERNP intervention was initiated within 48 hours of achieving hemodynamic stability and was delivered in three phases over 14 days: Phase 1 (Days 1-3) focused on bedside passive exercises and respiratory training; Phase 2 (Days 4-7) introduced progressive mobilization like sitting and assisted standing; and Phase 3 (Days 8-14) involved supervised ambulation. The study hypothesis was that the SERNP would accelerate recovery and improve outcomes by addressing both the physiological and psychosocial consequences of SAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Diagnosis of Severe Acute Pancreatitis (SAP) according to the Revised Atlanta Classification.
- •APACHE II score >
- •Expected ICU stay ≥ 14 days.
- •Hemodynamic stability (mean arterial pressure ≥ 65 mmHg for > 24 hours).
- •Provided informed consent.
排除标准
- •Presence of chronic metabolic disorders (e.g., end-stage renal disease, cirrhosis).
- •Coagulopathy (INR > 1.5 or platelet count < 50×10⁹/L).
- •Cognitive impairment hindering cooperation with the rehabilitation protocol.
- •Recent use of antiplatelet or anticoagulant medication (within 7 days).
结局指标
主要结局
Incidence of Complications
时间窗: From randomization until hospital discharge (an average of 14 days)
Percentage of patients who developed complications, including pressure ulcers, pneumonia, and venous thrombosis.
Time to Relief of Abdominal Distension
时间窗: From randomization up to hospital discharge (an average of 14 days)
Time in days from randomization until the resolution of abdominal distension, as assessed by clinical evaluation.
Time to First Bowel Movement
时间窗: From randomization up to hospital discharge (an average of 14 days)
Time in days from randomization until the first anal exhaust (bowel movement).
Duration of Hospital Stay
时间窗: From hospital admission up to hospital discharge (an average of 14 days)
Total length of stay in the hospital, measured in days.
Incidence of Complications
时间窗: From randomization until hospital discharge (an average of 14 days)
Percentage of patients who developed complications, including pressure ulcers, pneumonia, and venous thrombosis.
次要结局
- Activities of Daily Living (ADL) Score(Within 24 hours prior to Intensive Care Unit (ICU) discharge)
- Quality of Life (QoL) Score(At 48 hours prior to hospital discharge)
- Nursing Satisfaction(Within 24 hours prior to hospital discharge)
- Activities of Daily Living (ADL) Score(Within 24 hours prior to Intensive Care Unit (ICU) discharge)
- Quality of Life (QoL) Score(At 48 hours prior to hospital discharge)
- Nursing Satisfaction(Within 24 hours prior to hospital discharge)
研究者
Qiandi Huang
Principal investigator
Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University