- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07778355
Operating Room Orientation Video Education in Patients Undergoing Prostate Surgery
The Effect of Operating Room Orientation Video Education Applied at Different Times on Postoperative Pain and Anxiety in Patients Undergoing Prostate Surgery
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study will evaluate whether the timing of operating room orientation video education influences postoperative pain and state anxiety in patients undergoing surgery for benign prostatic hyperplasia. The intervention consists of a 5-minute video designed to familiarize patients with the perioperative environment and expected procedures. The video includes information about the operating room environment, the operating table, patient positioning, information related to the surgical process, the post-anesthesia care unit, and patient transfer.
Participants will be randomly allocated in a 1:1:1 ratio to one of three parallel groups. Participants in the first intervention group will receive the video approximately one day before surgery in the surgical ward. Participants in the second intervention group will receive the same video approximately 30 minutes before surgery in the operating room waiting unit. Participants in the control group will receive routine preoperative information according to standard clinical practice.
Pain intensity will be assessed using the Visual Analog Scale, and state anxiety will be assessed using the State-Trait Anxiety Inventory-State Anxiety Scale. Assessments will be performed one day before surgery, before the intervention in the operating room waiting unit, and six hours after surgery in the surgical ward.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Beyza Çakır
- Numéro de téléphone: +905372600955
- E-mail: beyzacakir7856@gmail.com
Lieux d'étude
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Atakum
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Samsun, Atakum, Turquie (Türkiye), 55500
- Ondokuz Mayıs University Health Practice and Research Center
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Contact:
- Beyza Çakır
- Numéro de téléphone: +905372600955
- E-mail: beyzacakir7856@gmail.com
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Chercheur principal:
- Beyza Çakır
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Sous-enquêteur:
- Özge İşeri, Associate professor
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Being conscious and able to communicate. Being able to read and understand Turkish. Voluntarily agreeing to participate in the study and providing informed consent.
Having no visual or hearing impairment that would interfere with viewing the educational video or completing the study assessments.
Undergoing prostate surgery for the first time. Being 18 years of age or older.
Exclusion Criteria:
- Having a diagnosed psychiatric disorder. Having a chronic pain syndrome. Being scheduled for emergency surgery. Having previously received similar operating room orientation education.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Ward Video Education Group
Participants will receive a 5-minute operating room orientation video approximately one day before surgery in the surgical ward.
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A 5-minute video-based educational intervention designed to familiarize patients with the operating room environment and the perioperative process.
The video includes information about the operating room environment, operating table, patient positioning, information related to the surgical process, the post-anesthesia care unit, and patient transfer.
|
|
Expérimental: Operating Room Waiting Unit Video Education Group
Participants will receive the same 5-minute operating room orientation video approximately 30 minutes before surgery in the operating room waiting unit.
|
A 5-minute video-based educational intervention designed to familiarize patients with the operating room environment and the perioperative process.
The video includes information about the operating room environment, operating table, patient positioning, information related to the surgical process, the post-anesthesia care unit, and patient transfer.
|
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Comparateur actif: Routine Information Control Group
Participants will receive routine preoperative information according to standard clinical practice without the study-specific operating room orientation video.
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Participants will receive routine preoperative information according to standard clinical practice without the study-specific operating room orientation video.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Postoperative state anxiety
Délai: From baseline to 6 hours after surgery
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State anxiety will be assessed using the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S), using the Turkish adaptation by Necla Öner and Ayhan Le Compte.
State anxiety will be assessed one day before surgery in the surgical ward, before video education in the operating room waiting unit, and 6 hours after surgery in the surgical ward.
The primary postoperative assessment will be the STAI-S score at 6 hours after surgery.
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From baseline to 6 hours after surgery
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Postoperative pain intensity
Délai: From baseline to 6 hours after surgery
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Pain intensity will be assessed using the Visual Analog Scale (VAS).
Pain will be assessed one day before surgery in the surgical ward, before video education in the operating room waiting unit, and 6 hours after surgery in the surgical ward.
The primary postoperative assessment will be the VAS score at 6 hours after surgery.
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From baseline to 6 hours after surgery
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
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
- Maladies urogénitales
- Maladies génitales
- La douleur
- Manifestations neurologiques
- Les troubles mentaux
- Complications postopératoires
- Processus pathologiques
- Maladies génitales, sexe masculin
- Maladies de la prostate
- Maladies urogénitales masculines
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Douleur, Postopératoire
- Troubles anxieux
- Hyperplasie prostatique
Autres numéros d'identification d'étude
- 2025/1127
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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