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Recruiting NCT07464626

Virtual vs Physical Art Therapy for Anxiety, Psychological Well-being, and Sleep Quality in Colorectal Cancer Patients

No phase Interventional Colorectal Cancer (Diagnosis) Anxiety Sleep Disturbance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Art Therapy, Physical Art Therapy.
Who it may be relevant to
Registry conditions: Colorectal Cancer (Diagnosis), Anxiety, Sleep Disturbance. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral Virtual Reality Art Therapy
    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.
  • Behavioral Physical Art Therapy
    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.

Primary outcome measures

  • Change in Anxiety Level [Time frame: Baseline and after completion of the fourth intervention session (8 weeks)]
Secondary outcome measures (2)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Dokuz Eylul University Hospital — Izmir

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. PMID 27695158
  • Hacmun 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. PMID 30429813
  • Jiang 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. PMID 32542749
  • Bosman 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. PMID 33188476

Identifiers

NCT: NCT07464626 · DokuzEU-SBE-EUT-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗