NCT07562802

Brief Summary

Patients in intensive care units experience significant physiological and psychological stress due to life-threatening conditions and invasive treatments. This randomized controlled study aims to examine the effects of virtual art therapy on physiological parameters, delirium risk, anger, anxiety, and mental-spiritual recovery in 62 patients in the coronary ICU of Malatya Training and Research Hospital. Data will be collected using validated scales and analyzed with appropriate parametric or non-parametric tests. The study seeks to evaluate the effectiveness and applicability of virtual art therapy as a technology-based complementary intervention in intensive care settings.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

April 25, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 25, 2026

Last Update Submit

April 25, 2026

Conditions

Keywords

AnxietyDeliriumNursingAngerSpiritual and Mental HealingVirtual Art TherapyIntensive Care

Outcome Measures

Primary Outcomes (4)

  • Nursing Delirium Screening Scale (Nu-DESC)

    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

    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:

    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

    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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Virtual Art Therapy

control

NO INTERVENTION

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.

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersDelirium

Condition Hierarchy (Ancestors)

Mental DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive Disorders

Central Study Contacts

Seher Çevik, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 1, 2026

Study Start

April 28, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL