Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07632131

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

Led by First Affiliated Hospital of Fujian Medical University · Updated on 2026-06-08

100

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate whether an ICU-based preventive narrative exposure intervention can help reduce posttraumatic stress symptoms in adult patients after cardiac surgery with cardiopulmonary bypass. The study includes adults undergoing this surgery who are admitted to the cardiac surgical intensive care unit, and it compares an intervention group receiving this narrative exposure support with a control group receiving routine care and psychological support. Participants in the intervention group will receive routine care plus a preventive narrative exposure intervention supported by an ICU visitor book. This intervention includes preoperative education, review of ICU experiences, timeline construction, guided narration of stressful ICU events, and integration of the experience before discharge. The ICU visitor book contains selected photos, family messages, and key recovery events to help patients better understand and organize their ICU stay. The control group will receive routine care and psychological support without the narrative intervention. During the study, participants will be assessed for posttraumatic stress symptoms one month after hospital discharge as the primary outcome. Secondary outcomes include symptoms at three months, ICU memories, anxiety, depression, sleep quality, quality of life, and satisfaction with ICU care. Researchers will monitor these measures to compare the effects of the intervention, with the study expected to end by April 2027.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Scheduled to undergo cardiac surgery with cardiopulmonary bypass
  • Planned postoperative admission to the cardiac surgical intensive care unit with an expected ICU stay over 24 hours
  • Able to communicate effectively and willing to cooperate along with family members
  • Conscious before the first postoperative intervention, negative for delirium, and able to understand and complete study procedures
Not Eligible

You will not qualify if you...

  • Experienced severe traumatic events within the past year, such as diagnosis of a major unrelated disease or death of an immediate family member
  • Currently receiving treatment for mental disorders like depressive disorder, anxiety disorder, bipolar disorder, or schizophrenia spectrum disorders
  • History of severe mental disorder or mental abnormalities caused by organic brain disease

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Inpatient Treatment

Duration - Perioperative and early recovery period during ICU stay

Participants receive routine care during cardiac surgery and ICU stay. Those in the intervention group also receive a preventive narrative exposure intervention using an ICU visitor book to help organize and process ICU experiences.

Visits coincide with ICU stay and perioperative period

Outpatient Treatment

Duration - Up to 1 month after hospital discharge

Participants continue to receive routine psychological support and complete study procedures after hospital discharge, including assessment of posttraumatic stress symptoms.

1 follow-up visit approximately 1 month after discharge

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China, 35005

Actively Recruiting

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Research Team

R

Rongjin Lin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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