Early Rehabilitation Nursing for Severe Acute Pancreatitis

NCT ID: NCT07076316

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-03-31

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.

Conditions

Acute Pancreatitis Drug-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ERN Group

Patients received a structured early rehabilitation nursing pathway (SERNP) in addition to routine care. The intervention was implemented within 48 hours of hemodynamic stability and included:

• Phase 1 (Days 1-3): Bedside passive range-of-motion exercises (10 min/session, 2x/day), respiratory training (lip pursing and abdominal breathing, 3 sessions/day), and gradual head-of-bed elevation (30° to 90°).
• Phase 2 (Days 4-7): Progressive mobilization including sitting at bedside (5-10 min, 3x/day) and assisted standing with a tilt-table (≤15 min/session).
• Phase 3 (Days 8-14): Supervised ambulation (2-5 meters, 2x/day) with mobility aids.

Group Type: EXPERIMENTAL

Structured Early Rehabilitation Nursing Pathway

Intervention Type: BEHAVIORAL

A multi-component, phased nursing intervention focused on early and progressive mobilization, respiratory exercises, and psychological support.

Control Group

Patients received routine care, which included vital sign monitoring, strict fasting, fluid balance recording, and passive limb mobilization twice daily.

Group Type: ACTIVE_COMPARATOR

Routine Care

Intervention Type: BEHAVIORAL

Standard nursing care for severe acute pancreatitis patients in the ICU, including monitoring and passive limb mobilization.

Interventions

Structured Early Rehabilitation Nursing Pathway

A multi-component, phased nursing intervention focused on early and progressive mobilization, respiratory exercises, and psychological support.

Intervention Type: BEHAVIORAL

Routine Care

Standard nursing care for severe acute pancreatitis patients in the ICU, including monitoring and passive limb mobilization.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qiandi Huang

OTHER

Sponsor Role: lead

Responsible Party

Qiandi Huang

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Affiliated Hospital of Jianghan University, The Sixth Hospital of Wuhan

Wuhan, Hubei, China

Countries

China

Other Identifiers

JHUSH-SAP-ERN-2021-01

Identifier Type: -

Identifier Source: org_study_id