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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in Anxiety Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to the nature of the intervention, participants and researchers cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •ECOG performance status of 3 or higher Patients who do not meet the inclusion criteria Patients unwilling to participate in the study
研究组 & 干预措施
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.
干预措施: Virtual Reality Art Therapy (Behavioral)
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.
干预措施: Physical Art Therapy (Behavioral)
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.
结局指标
主要结局
Change in Anxiety Level
时间窗: 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.
次要结局
- Change in Psychological Well-being(Baseline and after completion of the fourth intervention session (8 weeks))
- Change in Sleep Quality(Baseline and after completion of the fourth intervention session (8 weeks))
研究者
Esra Uslu Tanış
Principal Investigator
Dokuz Eylul University