THE EFFECTS OF VIRTUAL ART THERAPY ON PHYSIOLOGICAL PARAMETERS, DELIRIUM RISK, ANGER, ANXIETY, AND MENTAL AND SPIRITUAL RECOVERY IN INTENSIVE CARE PATIENTS.

April 25, 2026 updated by: seher ÇEVİK, Inonu University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Other: Virtual Art Therapy

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.
No 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
3 day
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).
3 days
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.
3 days
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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • inonu university 2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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