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NCT Number: NCT07076316

Early Rehabilitation Nursing for Severe Acute Pancreatitis

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.

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Key information

Conditions

Acute Pancreatitis Drug-Induced Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Jianghan University, The Sixth Hospital of Wuhan

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Structured Early Rehabilitation Nursing Pathway

Behavioral

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

Routine Care

Behavioral

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

Primary outcomes

  1. Time to Relief of Abdominal Distension

    Time frame: 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.

  2. Time to First Bowel Movement

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

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

  3. Duration of Hospital Stay

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

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

  4. Incidence of Complications

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

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

Secondary outcomes

  1. Activities of Daily Living (ADL) Score

    Time frame: 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.

  2. Quality of Life (QoL) Score

    Time frame: 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.

  3. Nursing Satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Qiandi Huang

Other

Registry information

Official study title

Effects of a Structured Early Rehabilitation Nursing Pathway on Gastrointestinal Recovery and Quality of Life in Severe Acute Pancreatitis Patients: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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