- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07464626
Virtual vs Physical Art Therapy for Anxiety, Psychological Well-being, and Sleep Quality in Colorectal Cancer Patients (PVART-CRC)
Effects of Virtual Art Therapy Delivered Through Virtual Reality Glasses and Physical Art Therapy on Anxiety, Psychological Well-being, and Sleep Quality in Patients With Colorectal Cancer: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Cancer and its treatments can lead to various psychological and physical symptoms, including anxiety, reduced psychological well-being, and impaired sleep quality. Non-pharmacological interventions such as art therapy have been increasingly used to support symptom management and improve psychological outcomes in patients with cancer.
This randomized controlled trial will evaluate the effectiveness of virtual reality-based art therapy and traditional physical art therapy in patients with colorectal cancer receiving outpatient chemotherapy. The study will be conducted at Dokuz Eylul University Hospital in Türkiye. The sample will consist of 78 adult patients diagnosed with colorectal cancer who meet the inclusion criteria.
Participants will be randomly assigned to one of three groups:
Virtual reality art therapy group Physical art therapy group Control group Patients in the intervention groups will participate in art therapy sessions every two weeks for a total of four sessions over eight weeks.
In the physical art therapy group, participants will create drawings using colored pencils and paper through structured therapeutic activities designed to promote emotional expression and stress management.
In the virtual reality art therapy group, participants will use a virtual reality headset and motion controllers to create drawings in a virtual painting environment using the Vermillion VR painting application. This immersive environment allows participants to engage in creative expression through digital art-making.
Each intervention session will last approximately 30 minutes. Standardized therapeutic prompts and breathing awareness exercises will be used at the beginning and end of each session.
Participants in the control group will receive routine care without art therapy interventions.
Data will be collected using the following instruments:
Sociodemographic and disease-related information form Hospital Anxiety and Depression Scale (HADS) Psychological Well-Being Scale Richards-Campbell Sleep Questionnaire Measurements will be conducted at baseline and after completion of the fourth session. Visual Analog Scale (VAS) scores will also be collected before and after each intervention session to evaluate immediate changes in anxiety levels.
The results of this study are expected to provide evidence regarding the effectiveness of virtual reality-based art therapy and physical art therapy as supportive care interventions for improving psychological outcomes and sleep quality in patients with colorectal cancer.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Esra Uslu Tanis, Msc
- Phone Number: +0905070049860
- Email: essrausl@gmail.com
Study Locations
-
-
Balçova
-
Izmir, Balçova, Turkey (Türkiye), 35330
- Recruiting
- Dokuz Eylul University Hospital
-
Contact:
- Ezgi Karadağ, professor
- Phone Number: +0905058135910
- Email: ezgikaradag44@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Art Therapy
Participants in this group will receive virtual reality-based art therapy using a virtual reality headset and motion controllers.
Patients will create drawings in a virtual painting environment using the Vermillion VR painting application.
Sessions will be conducted every two weeks for eight weeks, for a total of four sessions.
|
Participants will engage in art-making activities using a virtual reality headset and motion controllers.
The Vermillion VR painting application will be used to allow participants to create drawings in an immersive virtual environment.
Each session will last approximately 30 minutes and will be conducted every two weeks for a total of four sessions.
|
|
Experimental: Physical Art Therapy
Participants in this group will receive traditional art therapy sessions using colored pencils and paper.
Sessions will be conducted every two weeks for eight weeks, for a total of four sessions.
|
Participants will engage in structured art-making activities using colored pencils and paper.
Each participant will receive standard drawing materials and will be guided through therapeutic drawing exercises aimed at promoting emotional expression and stress reduction.
Each session will last approximately 30 minutes and will be conducted every two weeks for a total of four sessions.
|
|
No Intervention: Control Group
Participants in this group will receive routine care without art therapy interventions.
Outcome measurements will be collected at baseline and at the end of the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Anxiety Level
Time Frame: Baseline and after completion of the fourth intervention session (8 weeks)
|
Anxiety levels will be assessed using the Hospital Anxiety and Depression Scale (HADS).
The anxiety subscale consists of 7 items with scores ranging from 0 to 21.
Higher scores indicate higher levels of anxiety.
|
Baseline and after completion of the fourth intervention session (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Psychological Well-being
Time Frame: Baseline and after completion of the fourth intervention session (8 weeks)
|
Psychological well-being will be measured using the Psychological Well-Being Scale (Flourishing Scale).
The scale consists of 8 items scored on a 7-point Likert scale, with higher scores indicating greater psychological well-being.
|
Baseline and after completion of the fourth intervention session (8 weeks)
|
|
Change in Sleep Quality
Time Frame: Baseline and after completion of the fourth intervention session (8 weeks)
|
Sleep quality will be evaluated using the Richards-Campbell Sleep Questionnaire (RCSQ).
The scale uses a visual analog format ranging from 0 to 100, with higher scores indicating better sleep quality.
|
Baseline and after completion of the fourth intervention session (8 weeks)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kaimal G, Ray K, Muniz J. Reduction of cortisol levels and participants' responses following art making. Art Therapy. 2016;33(2):74-80.
- Hacmun I, Regev D, Solomon V. Art therapy in virtual reality: A qualitative study of art therapists' perspectives. Frontiers in Psychology. 2021.
- Jiang XH, Chen XJ, Xie QQ, et al. Effects of art therapy in cancer care: A systematic review and meta-analysis. European Journal of Cancer Care. 2020;29:e13277.
- Bosman JT, Bood ZM, Scherer-Rath M, et al. The effects of art therapy on anxiety, depression, and quality of life in adults with cancer: A systematic literature review. Supportive Care in Cancer. 2021;29:2289-2298.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Mental Disorders
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Pathological Conditions, Signs and Symptoms
- Behavior
- Personal Satisfaction
- Anxiety Disorders
- Colorectal Neoplasms
- Parasomnias
- Disease
- Sleep Initiation and Maintenance Disorders
- Psychological Well-Being
Other Study ID Numbers
- DokuzEU-SBE-EUT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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