Liver Transplant DisorderNCT06356532
the Intensive Care Unit Diary for Liver Transplant Recipients
A study testing intensive care unit diary in people with Liver Transplant Disorder, run by Chang Gung Memorial Hospital.
Trial summary
the purpose of this study is to assess the effectiveness of the intensive care unit diary for intensive care unit liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Transplant Disorder
- What is being tested?
- intensive care unit diary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- intensive care unit diary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive care unit diaryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
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)
Measured: post operation day 1 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jyun-Sian WU, Master, Study chair, Chang Gung Memorail Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356532
- Sponsor's protocol ID
- 202312197544
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effectiveness of the Intensive Care Unit Diary for Intensive Care Unit Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT06356532
- Acronym / sponsor ID
- 202312197544
- Conditions
- Liver Transplant Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: intensive care unit diaryThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive care unit diaryThe 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. | Behavioural | experimental group |
Primary outcome
change from baseline in depression on the Depression-Anxiety-Stress scale at post operation day 7 and day 14
Time frame: Baseline and 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)
change from baseline in anxiety on the Depression-Anxiety-Stress scale at post operation day 7 and day 14
Time frame: Baseline and 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)
change from baseline in stress on the Depression-Anxiety-Stress scale at post operation day 7 and day 14
Time frame: Baseline and 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)
change from baseline in sense of coherence on the Sense of Coherence Scale at post operation day 7 and day 14
Time frame: Baseline and 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)
change from baseline in emotional stress on the Brief Symptom Rating Scale at post operation day 7 and day 14
Time frame: Baseline and 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)
1 secondary outcome
change from baseline in delirium on the intensive care delirium screening checklist at post operation day 1 and day 14
Time frame: post operation day 1 and day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jyun-Sian WU, Master study chair
Chang Gung Memorail Hospital
Questions about this trial
What is this clinical trial studying?
A study testing intensive care unit diary in people with Liver Transplant Disorder, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jyun-Sian WU, Master (0979087979, wujyunsian@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in depression on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 (time frame: Baseline and post operation day 7 and day 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.