跳至主要内容
临床试验/CTRI/2025/05/087252
CTRI/2025/05/087252尚未招募2 期

An exploratory study to assess the effectiveness of Virtual Reality assisted Guided Imagery on quality of life of cancer patients undergoing Chemo-radiation treatment.

SMRATA Trust1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年8月6日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
Quality of Life using the FACT G

研究概览

简要总结

Cancer significantly impacts patients’ mental and physical well-being, with 25% to 60% reporting clinical distress. Chemoradiation, a common treatment, often leads to debilitating side effects. Guided imagery, especially when delivered through virtual reality (VR), has emerged as a promising non-invasive intervention to alleviate distress, reduce pain and anxiety, and improve mood and overall well-being. This study aims to assess the effectiveness of VR-assisted guided imagery in reducing distress among patients undergoing chemoradiation. The hypothesis posits that patients receiving this intervention will show higher quality-of-life scores (FACT-G) compared to those receiving standard care. A quasi-experimental, non-randomized design will be used.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • New patients aged 18 years to 70 years with a confirmed cancer diagnosis and enrolled in chemo-radiation 2) Able to provide informed consent 3) Eastern Cooperative Oncology Group (ECOG) performance status of 0–2 in order to prevent biasness among the patients and to check the patient’s performance status 4) Able to understand and complete the study questionnaires.

排除标准

  • Severe cognitive impairment or active psychiatric illness 2) Visual or auditory impairments that would prevent use of the VR device 3) Concurrent participation in other psychosocial interventions 4) History of seizures or motion sickness (contraindicated for VR use).

结局指标

主要结局

Quality of Life using the FACT G

时间窗: Weekly

次要结局

  • Distress reduction using the Distress Thermometer Scale(Weekly)

研究者

发起方
SMRATA Trust
申办方类型
Other [A Non Profit Organization]

研究点 (1)

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