Colorectal Cancer (Diagnosis)PVART-CRCNCT07464626
Virtual vs Physical Art Therapy for Anxiety, Psychological Well-being, and Sleep Quality in Colorectal Cancer Patients
A study testing Virtual Reality Art Therapy and Physical Art Therapy in people with Colorectal Cancer (Diagnosis) and Anxiety, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (Diagnosis), Anxiety, Sleep Disturbance
- What is being tested?
- Virtual Reality Art Therapy and Physical Art Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 30 Dec 2027
- 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
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University Hospital
Izmir, Balçova, 35330
Ezgi Karadağ, professor, +0905058135910, ezgikaradag44@gmail.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Colorectal Cancer (Diagnosis), Anxiety, Sleep Disturbance
- Being tested
- Virtual Reality Art Therapy, Physical Art Therapy
- Keywords
- Art Therapy, Virtual Reality Art Therapy, Psychological Well-being, Sleep Quality, Cancer Supportive Care, Non-pharmacological Intervention
- Medical subject headings
- Colorectal Neoplasms, Disease, Anxiety Disorders, Parasomnias, Psychological Well-Being, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Art TherapyBehavioural
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.
Physical Art TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Art Therapy | Experimental | 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. Receives: Behavioral: Virtual Reality Art Therapy |
| Physical Art Therapy | Experimental | 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. Receives: Behavioral: Physical Art Therapy |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Level
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.
Measured: Baseline and after completion of the fourth intervention session (8 weeks)
Secondary outcomes (2)
Change in Psychological Well-being
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.
Measured: Baseline and after completion of the fourth intervention session (8 weeks)
Change in Sleep Quality
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.
Measured: Baseline and after completion of the fourth intervention session (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer (Diagnosis)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to three parallel groups: a virtual reality art therapy group, a physical art therapy group, and a control group.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Uslu Tanış, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464626
- Sponsor's protocol ID
- DokuzEU-SBE-EUT-01
- Acronym
- PVART-CRC
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaimal G, Ray K, Muniz J. Reduction of Cortisol Levels and Participants' Responses Following Art Making. Art Ther (Alex). 2016 Apr 2;33(2):74-80. doi: 10.1080/07421656.2016.1166832. Epub 2016 May 23.
PubMed 27695158Hacmun I, Regev D, Salomon R. The Principles of Art Therapy in Virtual Reality. Front Psychol. 2018 Oct 31;9:2082. doi: 10.3389/fpsyg.2018.02082. eCollection 2018.
PubMed 30429813Jiang XH, Chen XJ, Xie QQ, Feng YS, Chen S, Peng JS. Effects of art therapy in cancer care: A systematic review and meta-analysis. Eur J Cancer Care (Engl). 2020 Sep;29(5):e13277. doi: 10.1111/ecc.13277. Epub 2020 Jun 15.
PubMed 32542749Bosman JT, Bood ZM, Scherer-Rath M, Dorr H, Christophe N, Sprangers MAG, van Laarhoven HWM. The effects of art therapy on anxiety, depression, and quality of life in adults with cancer: a systematic literature review. Support Care Cancer. 2021 May;29(5):2289-2298. doi: 10.1007/s00520-020-05869-0. Epub 2020 Nov 13.
PubMed 33188476
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07464626
- Acronym / sponsor ID
- PVART-CRC / DokuzEU-SBE-EUT-01
- Conditions
- Colorectal Cancer (Diagnosis), Anxiety, Sleep Disturbance
- Keywords
- Art Therapy, Virtual Reality Art Therapy, Psychological Well-being, Sleep Quality, Cancer Supportive Care, Non-pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 11 Mar 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to three parallel groups: a virtual reality art therapy group, a physical art therapy group, and a control group.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Art Therapy | Experimental | Behavioral: Virtual Reality Art TherapyParticipants 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. |
| Physical Art Therapy | Experimental | Behavioral: Physical Art TherapyParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 Reality Art TherapyParticipants 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. | Behavioural | Virtual Reality Art Therapy |
| Physical Art TherapyParticipants 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. | Behavioural | Physical Art Therapy |
Primary outcome
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.
2 secondary outcomes
Change in Psychological Well-being
Time frame: 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)
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 11 Mar 2026.
- Background: PubMed 27695158Kaimal G, Ray K, Muniz J. Reduction of Cortisol Levels and Participants' Responses Following Art Making. Art Ther (Alex). 2016 Apr 2;33(2):74-80. doi: 10.1080/07421656.2016.1166832. Epub 2016 May 23.
- Background: PubMed 30429813Hacmun I, Regev D, Salomon R. The Principles of Art Therapy in Virtual Reality. Front Psychol. 2018 Oct 31;9:2082. doi: 10.3389/fpsyg.2018.02082. eCollection 2018.
- Background: PubMed 32542749Jiang XH, Chen XJ, Xie QQ, Feng YS, Chen S, Peng JS. Effects of art therapy in cancer care: A systematic review and meta-analysis. Eur J Cancer Care (Engl). 2020 Sep;29(5):e13277. doi: 10.1111/ecc.13277. Epub 2020 Jun 15.
- Background: PubMed 33188476Bosman JT, Bood ZM, Scherer-Rath M, Dorr H, Christophe N, Sprangers MAG, van Laarhoven HWM. The effects of art therapy on anxiety, depression, and quality of life in adults with cancer: a systematic literature review. Support Care Cancer. 2021 May;29(5):2289-2298. doi: 10.1007/s00520-020-05869-0. Epub 2020 Nov 13.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Art Therapy and Physical Art Therapy in people with Colorectal Cancer (Diagnosis) and Anxiety, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Esra Uslu Tanis, Msc (+0905070049860, essrausl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Level (time frame: Baseline and after completion of the fourth intervention session (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07464626, which also lists 4 linked publications.
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 11 Mar 2026.