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Ligne directrice sur la prévention du délire pour les patients en soins intensifs

4 novembre 2026 mis à jour par: Ogretim Uyesi Serpil Topcu, Istanbul Demiroglu Bilim University

Évaluation de l'efficacité de l'utilisation des lignes directrices sur la prévention du délire pour les patients en soins intensifs

Delirium is a complication characterized by fluctuations in orientation, memory, thinking, or behavior, with sudden onset of these changes. Studies have shown that pharmacological agents are the most significant risk factors for delirium in intensive care units. In recent years, the impact of non-pharmacological interventions in preventing delirium development has started to be discussed.

Aperçu de l'étude

Statut

Complété

Intervention / Traitement

Description détaillée

Delirium is a complication characterized by fluctuations in orientation, memory, thinking, or behavior, with a sudden onset of these changes. Increased mortality and prolonged hospital stay have been identified in patients diagnosed with delirium. Advanced age, underlying urinary or respiratory tract infection, and existing cognitive impairment increase the risk of delirium development. Studies have shown that pharmacological agents are the most significant risk factors for delirium in intensive care units. However, environmental factors such as sound, continuous light, odors, invasive and non-invasive interventions, sensory overload, lack of meaningful verbal and cognitive stimuli, social isolation, immobilization, sleep disorders, temperature, drafts, and absence of windows in the environment are also indicated to contribute to delirium development. The presence of tubes, urinary catheters, invasive procedures, mechanical ventilation, and retention in the patient also increases the risk. In treatment, early detection and prevention of risk factors are prioritized. In case of development, efforts are made to prevent delirium-related complications and reduce its duration through pharmacological and non-pharmacological interventions. However, although many studies have been conducted on the prevention of delirium development with numerous pharmacological agents, a clear conclusion has not yet been reached. Pharmacological agents are generally used to alleviate symptoms. In recent years, the impact of non-pharmacological interventions in preventing delirium development has started to be discussed. Non-pharmacological interventions used in delirium prevention, as published by the National Institute for Health and Care Excellence (NICE), are itemized as pain management, prevention of dehydration, early mobilization, infection control, regulation of medications, sleep hygiene, and patient orientation. NICE also emphasizes the necessity of using a validated tool for assessing delirium.

A meta-analysis study has been published examining non-pharmacological interventions aimed at reducing the incidence of delirium, with a total of 26 studies included. According to this study, the methods that reduce the incidence are, respectively; family involvement, exercise program, multiple interventions (occupational therapy, reorientation, sleep therapy, music, etc.), ensuring cerebral hemodynamics, arranging the physical environment, and applying a sedation protocol. When the studies are examined, it is seen that efforts focus on ensuring sleep hygiene, maintaining patient orientation, and eliminating factors in the physical environment that may disrupt patient comfort. Evidence suggests strategies such as optimizing the environment, controlling light and noise, grouping patient care activities, and taking appropriate measures to preserve patients' sleep cycles to promote sleep regulation in adult ICU patients (Evidence: +1C). In the literature, studies have been conducted on the use of earplugs to protect ICU patients from noise and using eye masks to reduce exposure to light to ensure sleep hygiene. Delirium prevention strategies to be implemented should be compatible with clinical workflow. The method to be used should be easily adapted by all team members and patient relatives, and should be encouraged for use in clinical protocol. Collaboration between physicians, nurses, and patient relatives is essential in preventing delirium development. The pharmacological dimension of preventive interventions can be carried out by physicians, while non-pharmacological interventions can be implemented through collaboration between nurses and patient relatives. In this study, we aimed to determine the effect of guideline usage and team collaboration on the frequency of delirium development.

Type d'étude

Interventionnel

Inscription (Réel)

160

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.

Lieux d'étude

    • Şişli
      • Istanbul, Şişli, Turquie (Türkiye), 34394
        • Demiroğlu Bilim University

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Aged 18 and above,
  • Without motor, sensory, or hearing impairment,
  • Able to communicate,
  • Admitted to the intensive care unit within the first 24 hours of admission,
  • Without chronic cerebral damage,
  • Richmond Agitation Sedation Scale value between -1 and +1 at the beginning of the study,
  • Nursing Delirium Screening Scale (Nu-DESC) score <2,
  • No wounds or infections in the ears or eyes,
  • Patients who have given consent to participate in the study.

Exclusion Criteria:

  • Patients who receive sedation or require sedation during the data collection process, those who are unable to communicate due to intubation, those with diagnosed psychiatric disorders, those with profound hearing loss affecting communication, and those who do not wish to use eye masks and earplugs will be excluded from the study.

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: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Experimental

In the intervention group, initially, the Patient Identification Form, RASS, and Nu-DESC will be administered. The RASS and Nu-DESC forms will continue to be applied once a day throughout the patient's follow-up period in the intensive care unit, every 12 hours. Each intervention group patient randomized will receive the Delirium Prevention Guideline. The guideline includes standard practices used by intensive care nurses in patient monitoring. In addition to routine follow-ups, eye masks and earplugs will be applied to patients in the intervention group between 24:00 and 06:00. It is expected that the guideline will be used once every 24 hours, in the morning, to ensure standardization

Each intervention group patient randomized will receive the Delirium Prevention Guideline. The guideline is designed to be followed by nurses. However, collaboration with the physician is required for some aspects of the guideline (pain control, ordering/follow-up of laboratory tests, etc.). Support will be obtained from the intensive care physician, who is a member of the research team, for these steps. The guideline includes standard practices used by intensive care nurses in patient monitoring. In addition to routine follow-ups, eye masks and earplugs will be applied to patients in the intervention group between 24:00 and 06:00.

Aucune intervention: Control

Routine delirium monitoring conducted in the intensive care clinic will be performed for patients in this group. There is no standard form used for delirium in the unit where the study is conducted. At the beginning of data collection, the Control group patients will undergo the Patient Identification Form, RASS, and Nu-DESC (once every 12 hours). The RASS and Nu-DESC forms will continue to be applied once a day throughout the patient's follow-up period in the intensive care unit. Data collection will be terminated in case of delirium development in patients.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
In patients receiving Delirium Prevention Guidelines, the rate of delirium development is change compared to the control group at the end of one week.
Délai: 3 weeks

prevent delirium

3 weeks

Collaborateurs et enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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 (Réel)

15 juin 2024

Achèvement primaire (Réel)

15 février 2025

Achèvement de l'étude (Réel)

15 mars 2025

Dates d'inscription aux études

Première soumission

26 avril 2024

Première soumission répondant aux critères de contrôle qualité

3 mai 2024

Première publication (Réel)

7 mai 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 novembre 2026

Dernière vérification

1 avril 2025

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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

NON

Description du régime IPD

Researchers may share IPD data after the completion and publication of the study.

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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