the Intensive Care Unit Diary for Liver Transplant Recipients

NCT06356532 | Not Yet Recruiting

• 1 other identifier: 202312197544
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Transplant Disorder

Outcome Measures

Primary Outcomes (5)

• change from baseline in depression on the Depression-Anxiety-Stress scale at post operation day 7 and day 14

  The Depression-Anxiety-Stress scale is a validated, self reported instrument assessing depression over the past 7days period. Possible scores range from 0 (no depression)-21 (worst depression). Change=( post operation day 7 score-Baseline score)\&( post operation day 14 score-Baseline score)

  Baseline and post operation day 7 and day 14

• change from baseline in anxiety on the Depression-Anxiety-Stress scale at post operation day 7 and day 14

  The Depression-Anxiety-Stress scale is a validated, self reported instrument assessing anxiety over the past 7days period. Possible scores range from 0 (no anxiety)-21 (worst anxiety). Change=( post operation day 7 score-Baseline score)\&( post operation day 14 score-Baseline score)

  Baseline and post operation day 7 and day 14

• change from baseline in stress on the Depression-Anxiety-Stress scale at post operation day 7 and day 14

  The Depression-Anxiety-Stress scale is a validated, self reported instrument assessing stress over the past 7days period. Possible scores range from 0 (no stress)-21 (worst stress). Change=( post operation day 7 score-Baseline score)\&( post operation day 14 score-Baseline score)

  Baseline and post operation day 7 and day 14

• change from baseline in sense of coherence on the Sense of Coherence Scale at post operation day 7 and day 14

  The Sense of Coherence Scale is a validated, self reported instrument assessing sense of coherence. Possible scores range from 0 (worst)-91(best). Change=( post operation day 7 score-Baseline score)\&( post operation day 14 score-Baseline score)

  Baseline and post operation day 7 and day 14

• change from baseline in emotional stress on the Brief Symptom Rating Scale at post operation day 7 and day 14

  The Brief Symptom Rating Scale is a validated, self reported instrument assessing emotional distress. Possible scores range from 0 (best)-15(worst). Change=( post operation day 7 score-Baseline score)\&( post operation day 14 score-Baseline score)

  Baseline and post operation day 7 and day 14

Secondary Outcomes (1)

• change from baseline in delirium on the intensive care delirium screening checklist at post operation day 1 and day 14

  post operation day 1 and day 14

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Behavioral: intensive care unit diary

control group

NO INTERVENTION

The participants in the control group received the routine care including communication and companionship provided by the nurses of the intensive care unit.

Interventions

intensive care unit diary 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.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Officials

• Jyun-Sian WU, Master

  Chang Gung Memorail Hospital

  STUDY CHAIR

Central Study Contacts

Jyun-Sian WU, Master

CONTACT

0979087979; wujyunsian@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor is blinded to the group assignments of the patients. She is tasked with collecting the measured outcomes from the patients. 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 10, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share