Preventive Narrative Exposure Intervention for PTSD in ICU Patients After Cardiopulmonary Bypass Cardiac Surgery (ICU-pNET)

Effects of Preventive Narrative Exposure Intervention on Posttraumatic Stress Disorder Among ICU Patients After Cardiopulmonary Bypass Cardiac Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Stress Disorders, Post-Traumatic; Cardiopulmonary Bypass; Intensive Care Units
• Intervention / Treatment: Behavioral: ICU-Based Preventive Narrative Exposure Intervention

Detailed Description

Patients admitted to the intensive care unit after cardiac surgery with cardiopulmonary bypass may experience stressful events such as mechanical ventilation, invasive procedures, physical restriction, noise from monitoring devices, sleep disturbance, and uncertainty about their condition. These experiences may lead to fragmented ICU memories, gaps in factual understanding, frightening or unreal memories, and a persistent sense of threat after discharge. These factors may increase the risk of posttraumatic stress symptoms.

Existing supportive approaches, such as routine psychological education or ICU diaries, may help patients obtain factual information and emotional support. However, they may not sufficiently support patients in actively organizing and processing stressful ICU-related memories. Therefore, this study will test an ICU-based preventive narrative exposure intervention designed for patients after cardiopulmonary bypass cardiac surgery.

The intervention is delivered during the perioperative and early recovery period. It uses an ICU visitor book as a narrative support tool. The visitor book contains selected and privacy-protected photos, family messages, and key recovery events. These materials are used to help patients reconstruct the timeline of their ICU experience, understand what happened during treatment, and narrate stressful events in a guided and structured way. The intervention also includes brief education about stress reactions, grounding strategies, review of ICU experiences, and integration of the experience before discharge.

The intervention is preventive rather than therapeutic treatment for diagnosed posttraumatic stress disorder. It is intended to help patients form a more coherent and understandable account of their ICU experience, reduce distress related to fragmented or frightening memories, and support psychological recovery after cardiac surgery.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rongjin Lin; Phone Number: +86-18276524344; Email: Yaling_Qin0202@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 35005
      • Recruiting
      • The First Affiliated Hospital Of Fujian Medical University
      • Contact: Rongjin Lin; Phone Number: +86-18276524344; Email: Yaling_Qin0202@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICU-pNET Group; Participants in this group will receive routine care plus an ICU-based preventive narrative exposure intervention supported by an ICU visitor book.	Behavioral: 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.
No Intervention: Control Group; Participants in this group will receive routine care and routine psychological support during the perioperative and ICU recovery period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posttraumatic Stress Symptoms	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.	1 month after hospital discharge

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Cardiopulmonary Bypass; Stress Disorders, Post-Traumatic; Narrative Exposure
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2025-026-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study involves sensitive clinical and psychological information. Data sharing was not included in the approved informed consent documents.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No