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

2026년 8월 10일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Fujian
      • Fuzhou, Fujian, 중국, 35005
        • 모병
        • The First Affiliated Hospital of Fujian Medical University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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.
간섭 없음: Control Group
Participants in this group will receive routine care and routine psychological support during the perioperative and ICU recovery period.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Posttraumatic Stress Symptoms
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Posttraumatic stress symptoms at 3 months after hospital discharge
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

First Affiliated Hospital of Fujian Medical University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 2일

기본 완료 (추정된)

2027년 2월 28일

연구 완료 (추정된)

2027년 4월 30일

연구 등록 날짜

최초 제출

2026년 6월 3일

QC 기준을 충족하는 최초 제출

2026년 6월 3일

처음 게시됨 (실제)

2026년 6월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 10일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025-026-02

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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