the Intensive Care Unit Diary for Liver Transplant Recipients

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplant Disorder
• Intervention / Treatment: Behavioral: intensive care unit diary

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jyun-Sian WU, Master; Phone Number: 0979087979; Email: wujyunsian@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in delirium on the intensive care delirium screening checklist at post operation day 1 and day 14	The the intensive care delirium screening checklist is a validated instrument assessing delirium. Possible scores range from 0 (best)-8(worst). Change=( post operation day 14 score-post operation day 1 score)	post operation day 1 and day 14

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Jyun-Sian WU, Master, Chang Gung Memorail Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 30, 2024
• First Submitted That Met QC Criteria: April 7, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 202312197544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No