Anxiety PostoperativeNCT07576920
Anxiety Levels in Living Liver Donors
An observational study of Anxiety Postoperative, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Postoperative
- What is being tested?
- Anxiety scores
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2026to 27 Oct 2026
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Living liver donors
Who may be able to join
- ASA 1-2 group patients aged 18-65 years who are liver transplant donors
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Preoperative and Postoperative Anxiety in Living Liver Donors
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.
Read the 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.
- Conditions
- Anxiety Postoperative
- Being tested
- Anxiety scores
- Keywords
- Anxiety, Liver Transplantation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety scoresBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Living liver donors | Liver transplant donors who will undergo surgery between May and July 2026 Receives: Behavioral: Anxiety scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Scores
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).
Measured: From 24 hours prior to the operation to postoperative 3. day and 7. day
Secondary outcomes (2)
Presence of an alternative donor
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."
Measured: Prior to the operation
Recipient Prognosis
The relationship between the recipients prognosis and donors anxiety scores will be evaluated. This will be defined as the recipient living or not living
Measured: at the postoperative 3. day and 7. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start4 May 2026
- Primary completion15 Aug 2026
- Study completion27 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety PostoperativeStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekine Begec, Inonu University
- Investigators
- Zekine Begeç, professor, Principal investigator, Inonu University Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576920
- Sponsor's protocol ID
- Anxiety
- Status last verified
- Nov 2026
- First submitted
- 29 Apr 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34269646
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preoperative and Postoperative Anxiety in Living Liver Donors
- ClinicalTrials.gov ID
- NCT07576920
- Acronym / sponsor ID
- Anxiety
- Conditions
- Anxiety Postoperative
- Keywords
- Anxiety, Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 27 Oct 2026 (actual)
- First posted
- 8 May 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living liver donors | – | Behavioral: Anxiety scoresLiver transplant donors who will undergo surgery between May and July 2026 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Living liver donors
Key inclusion criteria (1 listed)
- ASA 1-2 group patients aged 18-65 years who are liver transplant donors
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| Anxiety scoresAnxiety 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. | Behavioural | Living liver donors |
Primary outcome
Anxiety Scores
Time frame: From 24 hours prior to the operation to postoperative 3. day and 7. day
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).
2 secondary outcomes
Presence of an alternative donor
Time frame: Prior to the operation
Recipient Prognosis
Time frame: at the postoperative 3. day and 7. day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 34269646Erdogan 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.
- 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.
Zekine Begeç, professor principal investigator
Inonu University Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Postoperative, run by Inonu University at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Scores (time frame: From 24 hours prior to the operation to postoperative 3. day and 7. day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07576920, which also lists 1 linked publication.
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 4 Nov 2026.