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Recruiting NCT07576920

Anxiety Levels in Living Liver Donors

Observational Anxiety Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anxiety scores.
Who it may be relevant to
Registry conditions: Anxiety Postoperative. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Preoperative and Postoperative Anxiety in Living Liver Donors

Overview

Anxiety is a state of worry and apprehension caused by internal and external threats. High preoperative anxiety levels have been associated with increased anesthetic requirements, higher morbidity, and mortality rates. In adult patients undergoing various surgical procedures, preoperative anxiety rates have been reported to range from 11% to 80%. Most studies show that postoperative anxiety levels are related to preoperative anxiety levels. In patients undergoing general anesthesia, anxiety levels increase a few days after surgery as issues related to recovery and pain become apparent. Patients with high postoperative anxiety levels have also been reported to have a higher rate of medical complications.

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.

Interventions

  • Behavioral Anxiety scores
    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.

Primary outcome measures

  • Anxiety Scores [Time frame: From 24 hours prior to the operation to postoperative 3. day and 7. day]
Secondary outcome measures (2)
  • Presence of an alternative donor [Time frame: Prior to the operation]
  • Recipient Prognosis [Time frame: at the postoperative 3. day and 7. day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Turgut Ozal Medical Center — Malatya

Publications

  • Erdogan MA, Ucar M, Ozgul U, Erdogan S, Colak YZ, Ozhan O, Yaman R, Ugur Y, Aydemir S, Parlakpinar H. Preoperative and Postoperative Endogenous Melatonin and Anxiety Levels and Their Correlation in Living Liver Donors. Exp Clin Transplant. 2025 Apr;23(4):278-284. doi: 10.6002/ect.2021.0060. Epub 2021 Jul 16. PMID 34269646

Identifiers

NCT: NCT07576920 · Anxiety

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗