Preventive Narrative Exposure Intervention for PTSD in ICU Patients After Cardiopulmonary Bypass Cardiac Surgery (ICU-pNET)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Rongjin Lin
- 電話番号：+86-18276524344
- メール：Yaling_Qin0202@163.com
研究場所
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Fujian
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Fuzhou、Fujian、中国、35005
- 募集
- The First Affiliated Hospital of Fujian Medical University
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コンタクト：
- Rongjin Lin
- 電話番号：+86-18276524344
- メール：Yaling_Qin0202@163.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
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介入なし：Control Group
Participants in this group will receive routine care and routine psychological support during the perioperative and ICU recovery period.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Posttraumatic Stress Symptoms
時間枠：1 month after hospital discharge
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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.
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1 month after hospital discharge
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Posttraumatic stress symptoms at 3 months after hospital discharge
時間枠：3 months after hospital discharge
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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.
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3 months after hospital discharge
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ICU-related memories
時間枠：Within 48 hours after ICU discharge, 1 month and 3 months after hospital discharge.
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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.
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Within 48 hours after ICU discharge, 1 month and 3 months after hospital discharge.
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Anxiety and depression symptoms
時間枠：Baseline, within 48 hours after ICU discharge, before hospital discharge, 1 month and 3 months after hospital discharge.
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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.
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Baseline, within 48 hours after ICU discharge, before hospital discharge, 1 month and 3 months after hospital discharge.
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Sleep quality
時間枠：Baseline, within 48 hours after ICU discharge, before hospital discharge, 1 month and 3 months after hospital discharge.
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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.
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Baseline, within 48 hours after ICU discharge, before hospital discharge, 1 month and 3 months after hospital discharge.
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Health-related quality of life
時間枠：1 month and 3 months after hospital discharge
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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.
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1 month and 3 months after hospital discharge
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Patient satisfaction with ICU nursing care
時間枠：1 week after ICU discharge
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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.
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1 week after ICU discharge
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Family satisfaction with ICU care
時間枠：1 week after ICU discharge
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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.
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1 week after ICU discharge
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025-026-02
個々の参加者データ (IPD) の計画
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IPD プランの説明
医薬品およびデバイス情報、研究文書
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米国FDA規制機器製品の研究
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