the Intensive Care Unit Diary for Liver Transplant Recipients

NCT ID: NCT06356532

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

experimental group

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.

Group Type: EXPERIMENTAL

intensive care unit diary

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Willingness to sign the written informed consent form.
• Admission to the intensive care unit for liver transplant surgery.
• Ability to read and write in Chinese and communicate in either Chinese or Taiwanese dialect.
• Adults aged 18 years or older, both male and female.

Exclusion Criteria

• Diagnosis of a mental illness.
• Presence of intellectual, cognitive, or hearing impairments.
• Use of sedative medications and scoring less than -2 on the Richmond Agitation-Sedation Scale (RASS).
• Inability of family members to visit during the patient's stay in the intensive care unit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jyun-Sian WU, Master

Role: STUDY_CHAIR

Chang Gung Memorail Hospital

Central Contacts

Jyun-Sian WU, Master

Role: CONTACT

wujyunsian@cgmh.org.tw

0979087979

Other Identifiers

202312197544

Identifier Type: -

Identifier Source: org_study_id