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Standardized Patient Education in Pituitary Surgery

24 mai 2026 mis à jour par: AKİF BULUT, Uludag University

The Impact of Standardized Patient Education on Patient Outcomes in Transsphenoidal Pituitary Surgery

Protocols are being developed and implemented to ensure the best possible recovery process for patients undergoing transsphenoidal surgery, and their impact on patient outcomes is being evaluated. In studies where perioperative protocols-including patient education (verbal and written instruction on dehydration, hyponatremia, adrenal insufficiency, CSF leakage, meningitis, and the signs and symptoms of visual or other neurological disorders)-are implemented, it has been reported that patients' length of hospital stay is reduced, the rate of patients experiencing hyponatremia has decreased, and readmissions have declined (Sanchez-Garavito et al., 2024; Sarris et al., 2021). However, since these studies included protocols covering the entire surgical process-not just patient education-it is difficult to determine whether changes in patient outcomes stem from patient education or from alterations in other parameters within the protocol.

Therefore, in the clinic where this study will be conducted, the effect of patient education on postoperative patient outcomes will be examined by developing an educational material that standardizes patient education, without making any changes to the surgical or pharmacological processes.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

102

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Admitted for elective surgery due to a pituitary tumor.
  • Has not previously undergone surgery for the same medical condition.
  • Has voluntarily agreed to participate in the study.
  • Has no missing medical data.
  • Can speak Turkish or understand what is being explained.
  • Patients aged 18 and older.

Exclusion Criteria:

  • Emergency surgery will be performed.
  • Revision surgery will be performed.
  • Those who voluntarily decline to participate in the study.
  • Those with incomplete medical data.
  • Those who cannot speak or understand Turkish.
  • Patients under the age of 18.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Education group
The standardized educational material to be used with the training group was developed by the researchers through a literature review and includes evidence-based recommendations that patients should follow after pituitary surgery. The educational material and the sources used to create it are included in the appendix. Before providing education to patients in the intervention group, nurses and resident physicians working in neurosurgery will receive in-person training on the rationale and details of the material. Patients will be included in the education program starting from their preoperative hospital admission; the content of the educational material will be explained by a nurse, and a visual copy will be provided to both the patient and their caregiver. Additionally, the material will be posted in a clearly visible location in the patient's room.
Autre: Standardized Pituitary Training
The standardized educational material to be used with the training group was developed by the researchers through a literature review and includes evidence-based recommendations that patients should follow after pituitary surgery. The educational material and the sources used to create it are included in the appendix. Before providing education to patients in the intervention group, nurses and resident physicians working in neurosurgery will receive in-person training on the rationale and details of the material. Patients will be included in the education program starting from their preoperative hospital admission; the content of the educational material will be explained by a nurse, and a visual copy will be provided to both the patient and their caregiver. Additionally, the material will be posted in a clearly visible location in the patient's room.
Aucune intervention: Control group
The control group for this study will consist of former patients who underwent pituitary surgery at the Neurosurgery Clinic prior to the start of this scientific study. Routine post-operative care at the clinic following pituitary surgery is as follows: patients who have undergone pituitary surgery are provided with information about the surgical process by the attending physician prior to surgery, and their voluntary written consent is obtained. After surgery, the physician, resident, and nurse provide verbal instructions to the patient regarding constipation and precautions related to the nose; however, no standardized written educational materials are used.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
The total time from admission to discharge for patients who received standardized patient education in transsphenoidal pituitary surgery
Délai: "From the registration phase through to the end of the 52-week training program"
"From the registration phase through to the end of the 52-week training program"

Mesures de résultats secondaires

Mesure des résultats
Délai
Complication rates (meningitis, hyponatremia, CSF leak) and rates of unplanned readmission among patients who received standardized training in transsphenoidal pituitary surgery during their hospital stay.
Délai: From the registration phase through to the end of the 52-week training program
From the registration phase through to the end of the 52-week training program

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Uludag University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 septembre 2027

Dates d'inscription aux études

Première soumission

24 mai 2026

Première soumission répondant aux critères de contrôle qualité

24 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026-8/11

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Due to the ethics committee's decision regarding the conduct of the study, the data will not be publicly disclosed. However, the data will be shared if a reasonable justification is provided.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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