- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07576920
Anxiety Levels in Living Liver Donors
Evaluation of Preoperative and Postoperative Anxiety in Living Liver Donors
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Zekine Begeç, Professor
- Telefonnummer: 3112 +904223410660
- E-Mail: zekine.begec@inonu.edu.tr
Studieren Sie die Kontaktsicherung
- Name: Muharrem Uçar, Professor
- Telefonnummer: 3112 +904223410660
- E-Mail: umuharrem@hotmail.com
Studienorte
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Malatya, Türkei (türkiye)
- Rekrutierung
- Turgut Ozal Medical Center
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Hauptermittler:
- Zekine Begec
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Kontakt:
- Zekine Begec, Dr
- Telefonnummer: +904223410660
- E-Mail: zekine.begec@inonu.edu.tr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Anxiety Scores
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Presence of an alternative donor
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Zekine Begeç, professor, Inonu University Department of Anesthesia
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Anxiety
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