- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07576920
Anxiety Levels in Living Liver Donors
Evaluation of Preoperative and Postoperative Anxiety in Living Liver Donors
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Zekine Begeç, Professor
- Numéro de téléphone: 3112 +904223410660
- E-mail: zekine.begec@inonu.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Muharrem Uçar, Professor
- Numéro de téléphone: 3112 +904223410660
- E-mail: umuharrem@hotmail.com
Lieux d'étude
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Malatya, Turquie (Türkiye)
- Recrutement
- Turgut Ozal Medical Center
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Chercheur principal:
- Zekine Begec
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Contact:
- Zekine Begec, Dr
- Numéro de téléphone: +904223410660
- E-mail: zekine.begec@inonu.edu.tr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Anxiety Scores
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Presence of an alternative donor
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Zekine Begeç, professor, Inonu University Department of Anesthesia
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Anxiety
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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