- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07576920
Anxiety Levels in Living Liver Donors
Evaluation of Preoperative and Postoperative Anxiety in Living Liver Donors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Liver transplantation is the only treatment for end-stage liver disease. The shortage of organ donations is leading clinicians to increasingly perform transplants from living donors. The biggest concern in living-donor liver transplantation is donor safety.
Liver donors undergo a major surgical operation that offers no medical benefit to them. The procedure can involve not only a physical but also a psychological burden. Given this situation, protecting both the physical and psychological health of liver donors is essential.
Anxiety studies primarily focus on organ transplant recipients However, the quality of life of donors and psychological conditions such as anxiety and depression are attracting increasing attention in the field of organ transplantation today. Neuropsychiatric Disease and Treatment 2018:14 1999-2005 A literature review revealed that there are limited studies investigating how donors are affected during the transplantation process in living-donor liver transplantation.
The aim of our study is to determine the preoperative and postoperative anxiety levels of donors in living donor liver transplantation and to identify possible conditions that may be associated with anxiety.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye), 44315
- Turgut Ozal Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ASA 1-2 group patients aged 18-65 years who are liver transplant donors
Exclusion Criteria:
- Patients with communication problems, those who are illiterate,
- Patients do not have sufficient time for the tests,
- Patients using sedatives, antidepressants, or antiepileptic drugs,
- Patients with cerebrovascular or psychiatric diseases,
- Patients with alcohol or substance addiction,
- Patients who do not want or cannot undergo the second test
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Living liver donors
Liver transplant donors who will undergo surgery between May and July 2026
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Anxiety scores will evaluated STAI test.
The STAI test consists of two sections of 20 questions each.
The first section of the test includes questions about how the person feels at that moment.
Answers are given on a scale of 4 points.
For example: I am calm right now: not at all=1, a little=2, a lot=3, completely=4.
The second section of the test includes questions about how the person feels in general and is also answered on a scale of 4 points.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anxiety Scores
Time Frame: From 24 hours prior to the operation to postoperative 3. day and 7. day
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The STAI test is a questionnaire comprising two, 20-item scales used to measure state and trait anxiety.
The anxiety levels of LLDs will be evaluated by using the STAI.
The STAI-State (STAI-S) form will be use to measure the current anxiety level.
The test includes questions about how the person feels at that moment.
Answers are given on a scale of 4 points.
For example: I am calm right now: not at all=1, a little=2, a lot=3, completely=4.
The STAI-Trait (STAI-T) form will be use to measure the underlying (ongoing/personality) anxiety level of the patient.
The test includes questions about how the person feels in general and is also answered on a scale of 4 points.
Each patient will complete these forms preoperatively and postoperatively.
The mean (total) score on the STAI has a minimum of 20 and a maximum of 80.
The STAI scores are generally classified as no anxiety or low anxiety (score of 20-37), moderate anxiety (score of 38-44), and high anxiety (score of 45-80).
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From 24 hours prior to the operation to postoperative 3. day and 7. day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Presence of an alternative donor
Time Frame: Prior to the operation
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The relationship between the presence or absence of an alternative donor and donors anxiety scores will be evaluated.
This will be defined as "alternative donor available" or "alternative donor not available."
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Prior to the operation
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Recipient Prognosis
Time Frame: at the postoperative 3. day and 7. day
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The relationship between the recipients prognosis and donors anxiety scores will be evaluated.
This will be defined as the recipient living or not living
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at the postoperative 3. day and 7. day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zekine Begeç, professor, Inonu University Department of Anesthesia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Anxiety
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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