Preventive Narrative Exposure Intervention for PTSD in ICU Patients After Cardiopulmonary Bypass Cardiac Surgery

NCT07632131 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Fujian Medical University

Phase

Not applicable

Started

2026-06-02

Last updated

2026-08-12

Condition(s) studied

Cardiopulmonary BypassIntensive Care UnitsStress Disorders, Post-Traumatic

Investigational drug(s) / intervention(s)

ICU-Based Preventive Narrative Exposure Intervention

ICU-Based Preventive Narrative Exposure Intervention: The intervention is an ICU-based preventive narrative exposure intervention supported by an ICU visitor book. It includes preoperative education, review of ICU experiences, construction of a timeline, guided narration of stressful ICU-related events, and integration of the experience before discharge. The ICU visitor book includes selected photos, family messages, and key recovery events to help participants better understand and organize their ICU experience.

Study summary

This clinical trial aims to evaluate whether an ICU-based preventive narrative exposure intervention can help prevent posttraumatic stress symptoms in adult patients after cardiac surgery with cardiopulmonary bypass.

The study will include adult patients who undergo cardiac surgery with cardiopulmonary bypass and are admitted to the cardiac surgical intensive care unit. Participants will be randomly assigned to either the intervention group or the control group.

Participants in the control group will receive routine care and routine psychological support. Participants in the intervention group will receive routine care plus an ICU-based preventive narrative exposure intervention supported by an ICU visitor book. The intervention includes preoperative education, review of ICU experiences, construction of a timeline, guided narration of stressful ICU-related events, and integration of the experience before discharge.

The ICU visitor book includes selected photos, family messages, and key recovery events. It is used to help patients better understand and organize their ICU experience.

Researchers will compare the intervention group with the control group to see whether the intervention reduces posttraumatic stress symptoms. The primary outcome is posttraumatic stress symptoms at 1 month after discharge. Secondary outcomes include posttraumatic stress symptoms at 3 months after discharge, ICU memories, anxiety, depression, sleep quality, quality of life, and patient and family satisfaction with ICU care.

The findings may provide evidence for an early psychological nursing intervention to prevent posttraumatic stress disorder in ICU patients after cardiopulmonary bypass cardiac surgery.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Aged 18 years or older. 2. Scheduled to undergo cardiac surgery with cardiopulmonary bypass, with planned postoperative admission to the cardiac surgical intensive care unit and an expected ICU stay of more than 24 hours. 3. The participant is able to communicate effectively, and the participant and family members are willing to cooperate with the study. 4. Conscious before the first postoperative intervention, negative for delirium as assessed by the Confusion Assessment Method for the Intensive Care Unit, and able to understand and complete the intervention and related assessments. Exclusion Criteria: 1. Experienced severe traumatic events within the past year, such as diagnosis of a major disease unrelated to the current cardiac condition in the participant or an immediate family member, or death of an immediate family member or significant other. 2. Currently receiving treatment for mental disorders, including pharmacological treatment or psychotherapy for conditions such as depressive disorder, anxiety disorder, bipolar disorder, or schizophrenia spectrum disorders. 3. History of a clearly diagnosed severe mental disorder, or mental abnormalities caused by organic brain disease.

Primary outcome measure(s)

Posttraumatic Stress Symptoms — 1 month after hospital discharge
Posttraumatic stress symptoms will be assessed using the Impact of Event Scale-Revised. The total score ranges from 0 to 88, with higher scores indicating more severe posttraumatic stress symptoms.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	Recruiting

More First Affiliated Hospital of Fujian Medical University trials in China

68Ga-NI-FAPI PET/CT: First-in-human Study Recruiting

Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After TKA Recruiting

18F-FAPIBiotin PET/CT: Dosimetry and Biodistribution Study Recruiting

PH-DyPred: A Multimodal Dynamic Risk Prediction Study in Pulmonary Hypertension Recruiting

Taining Golden Lake Comprehensive Chronic Disease Management Initiative Recruiting

Other trials for the same condition

Research on Circulation Management Strategy Based on Oxygen Metabolism Balance After CHD Surgery Enrolling by invitation

Concomitant Tricuspid Repair in Patients With Left Heart Surgery Starting soon

Protective Effect of RIPC Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII) Starting soon

rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) Starting soon

Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07632131 on ClinicalTrials.gov ↗ ← All trials in China