Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-30
Brief Title:
the Intensive Care Unit Diary for Liver Transplant Recipients
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
the Effectiveness of the Intensive Care Unit Diary for Intensive Care Unit Liver Transplant Recipients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ScaleData 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
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 ScaleData 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None