NCT06356532

the Intensive Care Unit Diary for Liver Transplant Recipients

the Effectiveness of the Intensive Care Unit Diary for Intensive Care Unit Liver Transplant Recipients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

the purpose of this study is to assess the effectiveness of the intensive care unit diary for intensive care unit liver transplant recipients.

Detailed description

This study was a prospective two-armed randomized clinical trial to assess the effectiveness of the intensive care unit diary for intensive care unit liver transplant recipients. The investigators used simple random allocation with a drawing from a lots container to divide the sample into an experimental group and a control group. The participants in the control group received the routine care including communication and companionship provided by the nurses of the intensive care unit. The participants in the intervention group received the intensive care unit diary writing and reading. Participants are required to write at least one sentence daily. The primary writers will be the patients themselves, and in cases where patients are unable to write, their family members will write on their behalf. After completion, the diary will be handed over to the patients to review its contents for at least 10 minutes before bedtime, allowing them to write down their immediate reflections and thoughts on when they read. This process will continue until the 14th day post-operation. There will be a total of three time questionnaire, each taking 10-15 minutes to complete. The first questionnaire will be administered upon enrollment and will include self-constructed basic demographic and disease-related attribute questionnaires, Depression-Anxiety-Stress scale, Brief Symptom Rating Scale , and a Sense of Coherence Scale. The second questionnaire will be administered on the 7th day post-operation, consisting of Depression-Anxiety-Stress scale, Brief Symptom Rating Scale , and a Sense of Coherence Scale. The third questionnaire will be administered on the 14th day post-operation, containing Depression-Anxiety-Stress scale, Brief Symptom Rating Scale , and a Sense of Coherence Scale.Data collection will be conducted by co-principal investigator of the research team. She will distribute the questionnaires at enrollment, and on the 7th and 14th days post-operation. Once notified by the researchers, data collector will distribute and collect the questionnaires. Upon completion, the questionnaires will be sealed in envelopes by the data collectors. The data will be analyzed to investigate the effectiveness of the intervention in reducing stress, depression, and anxiety in liver transplant patients, as well as sense of coherence and reducing the incidence of delirium.

Conditions

• Liver Transplant Disorder

Interventions

Type	Name	Description
BEHAVIORAL	intensive care unit diary	The intensive care unit diary is a notebook provided to patients during their stay in the intensive care unit, allowing them to record all events that occur during this period. Patients are encouraged to freely write about their experiences, which may include details about their treatment progress, daily activities, visits from family members, and other relevant aspects of their stay.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-04-10
• Last updated: 2024-04-10