An interventional study of ICU-Based Preventive Narrative Exposure Intervention in Cardiopulmonary Bypass, Intensive Care Units and Stress Disorders, Post-Traumatic, sponsored by First Affiliated Hospital of Fujian Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by First Affiliated Hospital of Fujian Medical University · Not applicable, Interventional, and Prevention
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.
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 100 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →First Affiliated Hospital of Fujian Medical University is the lead sponsor of 97 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
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
Participants in this group will receive routine care and routine psychological support during the perioperative and ICU recovery period.
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.
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.
Time frame: 1 month after hospital discharge
Posttraumatic stress symptoms at 3 months 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.
Time frame: 3 months after hospital discharge
ICU-related memories
ICU-related memories will be assessed using the ICU Memory Tool, a questionnaire designed to assess patients' recall of their ICU stay, including factual memories, memories of feelings, and delusional memories.
Time frame: Within 48 hours after ICU discharge, 1 month and 3 months after hospital discharge.
Anxiety and depression symptoms
Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS includes 14 items and consists of two subscales for anxiety and depression, with each subscale ranging from 0 to 21. Higher scores indicate more severe anxiety or depression symptoms.
Time frame: Baseline, within 48 hours after ICU discharge, before hospital discharge, 1 month and 3 months after hospital discharge.
Sleep quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The scale includes seven components, with the total score ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Time frame: Baseline, within 48 hours after ICU discharge, before hospital discharge, 1 month and 3 months after hospital discharge.
Health-related quality of life
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey. The scale includes 36 items covering eight domains of health status. Scores are transformed to a 0 to 100 scale, with higher scores indicating better health-related quality of life.
Time frame: 1 month and 3 months after hospital discharge
Patient satisfaction with ICU nursing care
Patient satisfaction with ICU nursing care will be assessed using the ICU Patient Hospitalization Satisfaction Questionnaire. The questionnaire includes 10 items rated on a 5-point Likert scale. Higher total scores indicate higher patient satisfaction.
Time frame: 1 week after ICU discharge
Family satisfaction with ICU care
Family satisfaction with ICU care will be assessed using the Chinese version of the Critical Care Family Satisfaction Survey. The scale includes 27 items rated on a 5-point Likert scale, with total scores ranging from 27 to 135. Higher scores indicate higher family satisfaction.
Time frame: 1 week after ICU discharge
Plan to share: No — 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.
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First Affiliated Hospital of Fujian Medical University