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临床试验/NCT04528238
NCT04528238撤回不适用

Multicentric, Randomized, Open-label Study to Assess the Impact of Relaxing Visual Immersion (RVI) on Reducing Anxiety During Intravenous Cancer Treatment in Cancer Patients.

Elsan0 个研究点开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Assess the impact of RVI on anxiety during the first intravenous cancer treatment session in cancer patients treated or not by anxiolytics

研究概览

简要总结

Since the 60's and 70's, the soar of audiovisual technologies allowed the development of virtual reality (VR). These technologies were then adapted to help reducing anxiety and pain during medical procedures. For visual or audio stimulation, the use of glasses or helmet is frequent. However, little is know about the efficacy of technologies which are not isolating the patient from his real environment during medical care. With this study, the investigators will assess the impact of this kind of sensitive stimulation without isolating the patient, on reducing the anxiety during intravenous treatment in patients with cancer. The machine the investigators are using is projecting relaxing nature movies on the ceiling of the room, with nature sounds or relaxing music.

详细描述

The diagnosis of cancer and the treatments used may be the cause, for the patient, of a significant emotional and psychological anxiety. For many years, several studies have evaluated the impact of visual and sensitive techniques on the well-being of the patient: landscaping of gardens,use of positive distraction means (decoration, brightness of spaces, photographs, layout of natural scenes, aquarium installation, etc.). The objective of these studies was to give to the patient a contact with nature reinforcing the positive emotions and reducing stress.

A randomized study including 37 patients who will undergo flexible sigmoidoscopy of diagnosis, to receive during the intervention, audio stimulation, audio and visual stimulation by glasses (Virtual IO, 1000 Leonora), or no stimulation. Audio and visual stimulation reduced abdominal discomfort (measured using visual analog scale VAS) and a decrease in anxiety (measured by the Stress Symptom Ratings scale) compared to the group without stimulation (p <0.05), but without solid evidence given the small number of patients with an imprecise randomization.

Other distraction systems using paintings of nature scenes combined with a listening to the sounds of nature were used during bronchoscopy: 80 patients were randomized (distraction systems versus control group without stimulation): the decrease in pain (rated on a 5-point scale from poor to excellent) was significantly greater in the intervention versus control group (p <0.015). There was no significant effect on anxiety measured by the S-STAI scale compared to the control group (with a 6 point difference between groups). Another Chinese prospective randomized controlled trial (Lee et al. 2004), conducted on 165 patients, has shown that visual and audio distraction (by Eyetrek system, Olympus) could reduce the need for sedatives used during colonoscopy compared to the group with visual distraction only and in the distraction-free control group (p <0.01). From the years 1960-1970, the development of digital audiovisual technologies allowed to develop virtual reality techniques. The term "virtual reality" (VR) refers to a computer technology that simulates artificially the user's environment, with which the user can interact. In oncology, virtual reality (VR) techniques have been used in 3 situations :

  • during painful procedures: A randomized controlled study conducted on 30 adolescents with cancer who will undergo a lumbar puncture, analyzed the impact of VR glasses on pain assessed by VAS and the feedback of the patients. There was no statistically significant difference between 2 groups but pain scores were lower in the VR group (The mean VAS in the VR group was 7 points with a range ranging from 0 to 48 while in the control group the average was 9 points with a range from 0 to 59).

Another randomized study conducted on 59 children with cancer whose treatments required access to a subcutaneous venous device assessed the value of VR distraction, non-virtual distraction and the absence of distraction. Reductions in pain and anxiety have been observed (measured by VAS) in children using VR distraction but were not significant given the small sample size. However the reduction of the heart rate was significant in the VR distraction group (p <0.05).

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 aged 18 and over.
  • Patient with cancer (any location) who need to receive an intravenous (IV) cancer treatment (adjuvant, neoadjuvant or palliative) when taking initial disease burden or upon relapse (the IV treatments concomitant with radiotherapy are also possible).
  • Patients scheduled for at least 3 consecutive sessions of IV anti-cancer treatment.
  • Patient under health insurance plan.
  • Information and signature of informed consent by the patient to participate in the study.

排除标准

  • Pregnant women.
  • Vulnerable patient (psychiatric illness, detainee, under legal protection, emancipated child).

结局指标

主要结局

Assess the impact of RVI on anxiety during the first intravenous cancer treatment session in cancer patients treated or not by anxiolytics

时间窗: Baseline : first visit for intravenous anti-cancer treatment.

Assessment of anxiety using the State-Trait Anxiety Inventory (STAI). The difference in the STAI-State anxiety score (STAI form Y-A) between e and after intervention will be studied in each group. A difference of at least 5 points of the change average before and after intervention between the experimental group and the control group will be considered as the minimum clinically significant difference.

次要结局

  • Assessment of the quality of life.(Up to 2 years, during 3 anti-cancer treatment sessions.)
  • Assessment of nausea.(Up to 2 years, during 3 anti-cancer treatment sessions.)
  • Assessment of psychological distress.(Up to 2 years, during 3 anti-cancer treatment sessions.)
  • Assessment of the quality of patient - caregiver communication.(Up to 2 years, during 3 anti-cancer treatment sessions.)
  • Assessment of the perception of elapsed time.(Up to 2 years, during 3 anti-cancer treatment sessions.)
  • Assessment of the anxiety.(Up to 2 years, during 3 anti-cancer treatment sessions.)
  • Assessment of pain felt.(Up to 2 years, during 3 anti-cancer treatment sessions.)
  • Assessment of the undesirable effects linked to the RVI.(Up to 2 years, during 3 anti-cancer treatment sessions.)
  • Analysis of the taking anti-anxiety treatments during anti-cancer treatment session(Up to 2 years, during 3 anti-cancer treatment sessions.)
  • Assessment of asthenia.(Up to 2 years, during 3 anti-cancer treatment sessions.)
  • Assessment of the vital signs.(Up to 2 years, during 3 anti-cancer treatment sessions.)

研究者

发起方
Elsan
申办方类型
Other
责任方
Sponsor

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