跳至主要内容
临床试验/NCT05365256
NCT05365256招募中不适用

Impact of Virtual Reality on the Mental Health of Patients Undergoing Adjuvant Treatment for Colorectal Cancer VIRECAPS2

Ramsay Générale de Santé2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2022年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
98
试验地点
2
主要终点
Level of psychological well-being

研究概览

简要总结

The increase in the survival of cancer patients and the incidence of cancers leads to a rapid increase in the number of people living after a diagnosis of cancer.

Occupation during chemotherapy treatment time has been identified as an excellent way to support cancer patients. Studies show that distraction interventions increase tolerance to treatment, by decreasing the importance given to negative stimuli associated with chemotherapy and increasing pleasurable emotions.

In this context, virtual reality (VR) is a promising intervention for patients receiving chemotherapy. VR is considered a powerful painkiller, even more effective than other distractors, such as movies or video games for example.

Several studies have shown short-term beneficial effects of integrating VR in patients undergoing chemotherapy. This intervention would help patients better adhere to and tolerate treatment. Considering that positive emotions could be one of the underlying processes necessary for the effectiveness of VR, it would be possible to support the cancer patient towards better overall well-being thanks to these new technologies.

Investigators can therefore ask themselves the question of the impact that VR used during chemotherapy can have on the adaptation of patients to the disease and its treatments as well as on their psychological distress in the medium and long term.

详细描述

The increase in the survival of cancer patients and the incidence of cancers leads to a rapid increase in the number of people living after a diagnosis of cancer. Supporting people during and after treatment is an element of the third Cancer Plan (2014-2019) promoting the emergence of innovations for the benefit of patients as well as the implementation of global and personalized actions of support, and wishing to reduce the impact of cancer on personal life.

Occupation during chemotherapy treatment time has been identified as an excellent way to support cancer patients. Studies show that distraction interventions (progressive relaxation, guided imagery, cognitive distractions such as reading, humor, listening to music, watching a movie, etc.) increase tolerance to treatment, by decreasing the importance given to negative stimuli associated with chemotherapy and increasing pleasurable emotions.

In this context, virtual reality (VR) is a promising intervention for patients receiving chemotherapy. It makes it possible to modulate the attentional and emotional processes responsible for physiological and psychic reactions (pain, psychological distress, anxiety). VR is considered a powerful painkiller, even more effective than other distractors, such as movies or video games for example.

Several studies have shown short-term beneficial effects of integrating VR in patients undergoing chemotherapy. This intervention would help patients better adhere to and tolerate treatment. Considering that positive emotions could be one of the underlying processes necessary for the effectiveness of VR, it would be possible to support the cancer patient towards better overall well-being thanks to these new technologies.

Investigators can therefore ask themselves the question of the impact that VR used during chemotherapy can have on the adaptation of patients to the disease and its treatments as well as on their psychological distress in the medium and long term.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female, over 18 years of age.
  • Patient with colorectal cancer treated with adjuvant chemotherapy.
  • Chemotherapy naïve patient
  • Patient speaking and understanding French and able to complete the questionnaires.
  • Affiliated patient or beneficiary of a social security scheme.
  • Patient having been informed of the research and having signed a free and informed consent

排除标准

  • Patient participating in another clinical study
  • Patient with a history or progressive psychiatric illness
  • Patient with severe visual and hearing impairment
  • Patient not supporting the wearing of the virtual reality headset
  • Patient who is unable to undergo medical monitoring for geographical, social or psychological reasons
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant, breastfeeding or parturient women

结局指标

主要结局

Level of psychological well-being

时间窗: 6 months

Total score from WEMWBS scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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