Early Rehabilitation Nursing for Severe Acute Pancreatitis

NCT07076316 | Completed

• 1 other identifier: JHUSH-SAP-ERN-2021-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis Drug-Induced

Keywords

Early Rehabilitation Nursing; Severe Acute Pancreatitis; Patient-Centered Care; Functional Recovery; Critical Care; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Time to Relief of Abdominal Distension

  Time in days from randomization until the resolution of abdominal distension, as assessed by clinical evaluation.

  From randomization up to hospital discharge (an average of 14 days)

• Time to First Bowel Movement

  Time in days from randomization until the first anal exhaust (bowel movement).

  From randomization up to hospital discharge (an average of 14 days)

• Duration of Hospital Stay

  Total length of stay in the hospital, measured in days.

  From hospital admission up to hospital discharge (an average of 14 days)

• Incidence of Complications

  Percentage of patients who developed complications, including pressure ulcers, pneumonia, and venous thrombosis.

  From randomization until hospital discharge (an average of 14 days)

Secondary Outcomes (3)

• 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

Study Arms (2)

ERN Group

EXPERIMENTAL

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.

Behavioral: Structured Early Rehabilitation Nursing Pathway

Control Group

ACTIVE COMPARATOR

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

Behavioral: Routine Care

Interventions

Structured Early Rehabilitation Nursing Pathway BEHAVIORAL

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

ERN Group

Routine Care BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Qiandi Huang: lead

Study Sites (1)

Affiliated Hospital of Jianghan University, The Sixth Hospital of Wuhan

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 22, 2025
• Study Start: February 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 22, 2025

Record last verified: 2025-06

Locations

CN (1)