Delirium RiskNCT07562802
THE EFFECTS OF VIRTUAL ART THERAPY ON PHYSIOLOGICAL PARAMETERS, DELIRIUM RISK, ANGER, ANXIETY, AND MENTAL AND SPIRITUAL RECOVERY IN INTENSIVE CARE PATIENTS.
A study testing Virtual Art Therapy in people with Delirium Risk and Critical Illness in Coronary ICU Patients, run by Inonu University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium Risk, Critical Illness in Coronary ICU Patients, Mental and Spiritual Recovery
- What is being tested?
- Virtual Art Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Patients treated in intensive care units are under both physiological and psychological stress due to life-threatening illnesses, invasive procedures, prolonged stays in isolated environments, and a process full of uncertainty. In coping with this process, alternative and complementary approaches are emerging alongside medical treatment. Virtual art therapy, which has emerged as a result of adapting traditional art therapy practices to digital and virtual environments with technology, is being investigated as a new treatment method to help patients relax and support their physical and mental recovery. The aim of this research is to examine the effect of virtual art therapy on physiological parameters, delirium risk, anger, anxiety levels, and mental and spiritual recovery in intensive care patients. The research will be conducted in the coronary intensive care unit of Malatya Training and Research Hospital. The research population will consist of patients followed in the aforementioned unit. The sample will consist of 62 patients determined by power analysis. After the patients are randomized and assigned to their groups, the experimental group will be asked to paint using virtual reality glasses. The research data will be collected through the Personal Introduction and Monitoring Form, the Nursing Delirium Screening Scale, the State Anger Scale, the Integrated Anxiety Scale, and the Mental and Spiritual Recovery Assessment Scale Short Form. Descriptive statistics, Independent Samples t-test/Mann Whitney U test, and Dependent Samples T-test/Wilcoxon test for comparing repeated measures within groups will be used in the evaluation of the data. The research aims to reveal the potential of virtual art therapy to accelerate the mental and emotional recovery of patients beyond traditional treatment methods. It also aims to test the applicability of technology-based alternative treatment methods in intensive care settings where the application area of this therapy is limited. The results of this research, which will show that alternative treatment methods such as art therapy and virtual reality can be used as an effective tool, especially in intensive care units, can make a significant contribution to the fields of nursing and medical treatment.
- Conditions
- Delirium Risk, Critical Illness in Coronary ICU Patients, Mental and Spiritual Recovery, Effects of Virtual Art Therapy
- Being tested
- Virtual Art Therapy
- Keywords
- Anxiety, Delirium, Nursing, Anger, Spiritual and Mental Healing, Virtual Art Therapy, Intensive Care
- Medical subject headings
- Anxiety Disorders, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Art TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start28 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium RiskStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seher ÇEVİK, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562802
- Sponsor's protocol ID
- inonu university 2026
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF VIRTUAL ART THERAPY ON PHYSIOLOGICAL PARAMETERS, DELIRIUM RISK, ANGER, ANXIETY, AND MENTAL AND SPIRITUAL RECOVERY IN INTENSIVE CARE PATIENTS.
- ClinicalTrials.gov ID
- NCT07562802
- Acronym / sponsor ID
- inonu university 2026
- Conditions
- Delirium Risk, Critical Illness in Coronary ICU Patients, Mental and Spiritual Recovery, Effects of Virtual Art Therapy
- Keywords
- Anxiety, Delirium, Nursing, Anger, Spiritual and Mental Healing, Virtual Art Therapy, Intensive Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 28 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients treated in intensive care units are under both physiological and psychological stress due to life-threatening illnesses, invasive procedures, prolonged stays in isolated environments, and a process full of uncertainty. In coping with this process, alternative and complementary approaches are emerging alongside medical treatment. Virtual art therapy, which has emerged as a result of adapting traditional art therapy practices to digital and virtual environments with technology, is being investigated as a new treatment method to help patients relax and support their physical and mental recovery. The aim of this research is to examine the effect of virtual art therapy on physiological parameters, delirium risk, anger, anxiety levels, and mental and spiritual recovery in intensive care patients. The research will be conducted in the coronary intensive care unit of Malatya Training and Research Hospital. The research population will consist of patients followed in the aforementioned unit. The sample will consist of 62 patients determined by power analysis. After the patients are randomized and assigned to their groups, the experimental group will be asked to paint using virtual reality glasses. The research data will be collected through the Personal Introduction and Monitoring Form, the Nursing Delirium Screening Scale, the State Anger Scale, the Integrated Anxiety Scale, and the Mental and Spiritual Recovery Assessment Scale Short Form. Descriptive statistics, Independent Samples t-test/Mann Whitney U test, and Dependent Samples T-test/Wilcoxon test for comparing repeated measures within groups will be used in the evaluation of the data. The research aims to reveal the potential of virtual art therapy to accelerate the mental and emotional recovery of patients beyond traditional treatment methods. It also aims to test the applicability of technology-based alternative treatment methods in intensive care settings where the application area of this therapy is limited. The results of this research, which will show that alternative treatment methods such as art therapy and virtual reality can be used as an effective tool, especially in intensive care units, can make a significant contribution to the fields of nursing and medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Virtual Art TherapyPatients 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Art TherapyThe 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. | Other | Intervention |
Primary outcome
Nursing Delirium Screening Scale (Nu-DESC)
Time frame: 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).
State Anger Scale
Time frame: 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).
Integrated Anxiety Scale:
Time frame: 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.
Mental and Spiritual Recovery Assessment Scale - Short Form
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Art Therapy in people with Delirium Risk and Critical Illness in Coronary ICU Patients, run by Inonu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seher Çevik, PhD (+905531463844, seherrcvk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nursing Delirium Screening Scale (Nu-DESC) (time frame: 3 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.