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

10 augustus 2026 bijgewerkt door: Rongjin Lin, First Affiliated Hospital of Fujian Medical University

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Fujian
      • Fuzhou, Fujian, China, 35005
        • Werving
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: Control Group
Participants in this group will receive routine care and routine psychological support during the perioperative and ICU recovery period.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Posttraumatic Stress Symptoms
Tijdsspanne: 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.
1 month after hospital discharge

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Posttraumatic stress symptoms at 3 months after hospital discharge
Tijdsspanne: 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.
3 months after hospital discharge
ICU-related memories
Tijdsspanne: Within 48 hours after ICU discharge, 1 month and 3 months after hospital discharge.
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.
Within 48 hours after ICU discharge, 1 month and 3 months after hospital discharge.
Anxiety and depression symptoms
Tijdsspanne: Baseline, within 48 hours after ICU discharge, before hospital discharge, 1 month and 3 months after hospital discharge.
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.
Baseline, within 48 hours after ICU discharge, before hospital discharge, 1 month and 3 months after hospital discharge.
Sleep quality
Tijdsspanne: Baseline, within 48 hours after ICU discharge, before hospital discharge, 1 month and 3 months after hospital discharge.
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.
Baseline, within 48 hours after ICU discharge, before hospital discharge, 1 month and 3 months after hospital discharge.
Health-related quality of life
Tijdsspanne: 1 month and 3 months after hospital discharge
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.
1 month and 3 months after hospital discharge
Patient satisfaction with ICU nursing care
Tijdsspanne: 1 week after ICU discharge
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.
1 week after ICU discharge
Family satisfaction with ICU care
Tijdsspanne: 1 week after ICU discharge
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.
1 week after ICU discharge

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

First Affiliated Hospital of Fujian Medical University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 juni 2026

Primaire voltooiing (Geschat)

28 februari 2027

Studie voltooiing (Geschat)

30 april 2027

Studieregistratiedata

Eerst ingediend

3 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

8 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

10 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025-026-02

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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