- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07562802
THE EFFECTS OF VIRTUAL ART THERAPY ON PHYSIOLOGICAL PARAMETERS, DELIRIUM RISK, ANGER, ANXIETY, AND MENTAL AND SPIRITUAL RECOVERY IN INTENSIVE CARE PATIENTS.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Seher Çevik, PhD
- Numero di telefono: +905531463844
- Email: seherrcvk@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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. |
|
Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Nursing Delirium Screening Scale (Nu-DESC)
Lasso di tempo: 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).
|
3 day
|
|
State Anger Scale
Lasso di tempo: 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).
|
3 days
|
|
Integrated Anxiety Scale:
Lasso di tempo: 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.
|
3 days
|
|
Mental and Spiritual Recovery Assessment Scale - Short Form
Lasso di tempo: 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.
|
3 days
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- inonu university 2026
Piano per i dati dei singoli partecipanti (IPD)
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Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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