Dokuz Eylul University Hospital
Izmir, Balçova, 35330, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07464626
This randomized controlled trial aims to evaluate the effects of virtual reality-based art therapy and physical art therapy on anxiety, psychological well-being, and sleep quality in patients with colorectal cancer receiving outpatient chemotherapy. A total of 78 patients will be randomly assigned to three groups: a virtual reality art therapy group, a physical art therapy group, and a control group. Participants in the intervention groups will receive art therapy sessions every two weeks for eight weeks (four sessions in total). Anxiety, psychological well-being, and sleep quality will be assessed using validated scales before the intervention and after the fourth session. The findings are expected to contribute to the development of non-pharmacological supportive care interventions for oncology patients.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Izmir, Balçova, 35330, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age 18 years or older Diagnosed with colorectal cancer Receiving outpatient chemotherapy (FOLFOX or XELOX regimen) ECOG performance status between 0 and 2 Not receiving radiotherapy No hearing or speech impairments No severe psychiatric disorders (e.g., schizophrenia, major depression, bipolar disorder) Able to understand the study procedures and provide informed consent Willing to participate in the study Exclusion Criteria ECOG performance status of 3 or higher Patients who do not meet the inclusion criteria Patients unwilling to participate in the study
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Dokuz Eylul University
Other
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
Acronym: PVART-CRC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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