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

NCT07632131 | Recruiting

• 1 other identifier: 2025-026-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiopulmonary Bypass; Intensive Care Units; Stress Disorders, Post-Traumatic

Keywords

Cardiopulmonary Bypass; Intensive Care Unit; Narrative Exposure; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ICU-pNET Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants in this group will receive routine care and routine psychological support during the perioperative and ICU recovery period.

Interventions

ICU-Based Preventive Narrative Exposure Intervention BEHAVIORAL

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.

ICU-pNET Group

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older.
• 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.
• The participant is able to communicate effectively, and the participant and family members are willing to cooperate with the study.
• 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.

You may not qualify if:

• 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.
• 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.
• History of a clearly diagnosed severe mental disorder, or mental abnormalities caused by organic brain disease.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 35005, China

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Rongjin Lin

CONTACT

+86-18276524344; Yaling_Qin0202@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. No masking will be used because the intervention is a behavioral nursing intervention and participants and intervention providers will be aware of group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Nurse

Model Details: Participants will be randomly assigned in a 1:1 ratio to the intervention group or the control group.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)