- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07562802
THE EFFECTS OF VIRTUAL ART THERAPY ON PHYSIOLOGICAL PARAMETERS, DELIRIUM RISK, ANGER, ANXIETY, AND MENTAL AND SPIRITUAL RECOVERY IN INTENSIVE CARE PATIENTS.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Seher Çevik, PhD
- Numéro de téléphone: +905531463844
- E-mail: seherrcvk@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Being 18 years of age or older Voluntarily agreeing to participate in the study Having no medical diagnosis that may trigger dizziness Having a score of 14 or higher on the Glasgow Coma Scale
Exclusion Criteria:
- Refusing to participate in the study Having any psychiatric diagnosis Having a medical diagnosis that may trigger dizziness Having a score of 13 or lower on the Glasgow Coma Scale
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Intervention
Patients in the intervention group will engage in a virtual painting activity once daily for three consecutive days using a virtual reality (VR) headset. The Meta Quest 3 VR headset and hand controllers will be utilized in the study. For the painting activity, the Vermillion - VR Painting application will be employed. This application is a sophisticated platform that simulates the traditional oil painting experience within a virtual reality environment. Rather than primarily offering pre-designed templates, it enables users to create original artworks on a blank canvas by using digital reproductions of physical painting materials, thereby supporting the authentic artistic creation process. Educational reference images and basic composition guides are also available within the application. The duration of each painting session may vary considerably depending on the participant's experience level, the complexity of the work, and the intended level of detail. While a simple sketch or stu |
The Vermillion - VR Painting application will be used to have the patient paint. This application is a sophisticated tool that simulates the traditional oil painting experience in a virtual reality environment. Users can create original works starting from a completely blank canvas; the application primarily supports the artistic creation process by using digital reproductions of real physical painting materials rather than offering ready-made templates. In addition, reference images and basic composition guides are available for educational purposes. The duration of a painting activity can vary significantly depending on the user's experience level, the complexity of the work, and the level of detail targeted; a simple sketch or study may take 15-30 minutes, while a complex composition or portrait may require several hours, or even multiple sessions for experienced users. The writing areas can be extended as needed. |
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Aucune intervention: control
No intervention will be administered to the control group throughout the study period, and patients will continue to receive routine medical and nursing care.
Parallel to the experimental group, on the third day, patients in the control group will be administered the Nursing Delirium Screening Scale, the State Anger Scale, the Integrated Anxiety Scale, and the Mental and Spiritual Recovery Assessment Scale - Short Form.
Vital signs will also be measured and recorded at that time.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Nursing Delirium Screening Scale (Nu-DESC)
Délai: 3 day
|
The Nursing Delirium Screening Scale (Nu-DESC) was developed by Gaudreau et al. in 2005.
The Turkish adaptation of the scale was conducted by Karataş and Bağlama (2021).
Nu-DESC is a rapid and practical screening tool that can be easily implemented in routine nursing practice.
The scale consists of five items assessed based on nurses' clinical observations: disorientation, inappropriate behavior, inappropriate communication, illusions/hallucinations, and psychomotor retardation.
Each item is scored from 0 (absent) to 2 (severe), with a maximum possible total score of 10.
The evaluation is based on observations accumulated over a 12-hour period.
A total score of 2 or higher is considered positive for delirium.
The internal consistency coefficient of the scale was reported as 0.74 (Karataş & Samancıoğlu, 2023).
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3 day
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State Anger Scale
Délai: 3 days
|
The State Anger Scale, developed by Spielberger (1999), is a unidimensional instrument designed to assess individuals' current level of anger.
The Turkish adaptation was conducted by Cankardaş and Şalcıoğlu.
The scale consists of 10 items, each rated on a 4-point Likert scale (1 = Not at all, 2 = Somewhat, 3 = Moderately, 4 = Very much).
Total scores range from 10 to 40, with higher scores indicating higher levels of state anger.
The internal consistency coefficient was reported as 0.94 (Cankardaş & Şalcıoğlu, 2021).
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3 days
|
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Integrated Anxiety Scale:
Délai: 3 days
|
The Integrated Anxiety Scale was developed by Ebadi (2020) and consists of 33 items.
Each item is rated on a 5-point scale ranging from 0 (Never) to 4 (Always).
The total score ranges from 0 to 132, with higher scores indicating higher levels of anxiety and stress.
The internal consistency coefficient of the scale was reported as 0.96.
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3 days
|
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Mental and Spiritual Recovery Assessment Scale - Short Form
Délai: 3 days
|
The Mental and Spiritual Recovery Assessment Scale - Short Form was developed by Barber et al. (2017) to evaluate individuals' levels of mental and spiritual recovery.
The Turkish adaptation was conducted by Danış and Günaydın (2024).
The scale consists of 15 items rated on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree).
It includes three subdimensions: Existential Well-Being, Religious Well-Being, and Spiritual Distress.
The total score ranges from 15 to 75, with higher scores indicating greater levels of mental and spiritual recovery.
The internal consistency coefficient (Cronbach's alpha) of the Turkish version was reported as 0.864 for the total scale, with subscale coefficients ranging from 0.773 to 0.953.
The Turkish validity and reliability study demonstrated adequate construct validity, linguistic validity, and item analysis results.
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3 days
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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
Autres numéros d'identification d'étude
- inonu university 2026
Plan pour les données individuelles des participants (IPD)
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Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
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