Acute Pancreatitis Drug-Induced
Conditions
Keywords
Early Rehabilitation Nursing, Severe Acute Pancreatitis, Patient-Centered Care, Functional Recovery, Critical Care, Quality of Life
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStructured Early Rehabilitation Nursing Pathway
A multi-component, phased nursing intervention focused on early and progressive mobilization, respiratory exercises, and psychological support.
BEHAVIORALRoutine Care
Standard nursing care for severe acute pancreatitis patients in the ICU, including monitoring and passive limb mobilization.
Sponsors
Qiandi Huang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Severe Acute Pancreatitis (SAP) according to the Revised Atlanta Classification. * APACHE II score \> 8. * Expected ICU stay ≥ 14 days. * Hemodynamic stability (mean arterial pressure ≥ 65 mmHg for \> 24 hours). * Provided informed consent.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Relief of Abdominal Distension | 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 | 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 | 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 | From randomization until hospital discharge (an average of 14 days) | Percentage of patients who developed complications, including pressure ulcers, pneumonia, and venous thrombosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) Score | At 48 hours prior to hospital discharge | Quality of life assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire. This measures four domains: physical health, psychological health, social relationships, and environment. Scores are transformed to a 0-100 scale, with higher scores indicating better QoL. |
| Nursing Satisfaction | Within 24 hours prior to hospital discharge | Patient satisfaction with nursing care, measured using a 10-item Likert scale developed for ICU settings. The rate of patients rating care as satisfied or very satisfied was calculated. |
| Activities of Daily Living (ADL) Score | Within 24 hours prior to Intensive Care Unit (ICU) discharge | Functional independence measured using the Barthel Index (BI). The scale ranges from 0 to 100, with higher scores indicating greater independence. |
Countries
China
Outcome results
None listed