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Impact of Relaxing Visual Immersion on Anxiety During Anti-cancer Treatment.

2022年10月25日 更新者:Elsan

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

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.

研究概览

地位

撤销

条件

详细说明

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).

- during hospitalization: This situation is considered stressful because it is linked to a change in the state of health and because it introduces stressful conditions like lack of autonomy, privacy, etc.

A study showed on 19 hospitalized patients with metastatic cancer, exposed to 4 sessions of 30 minutes for 1 week with a VR headset, an increase in joy over the 4 sessions (before and after the test, p <0.009) and a decrease in sadness over the 2nd session (before and after the test, p <0.003).

Another study showed on 33 hospitalized patients with metastatic cancer under the same conditions as the Banos study, an increase in positive emotions and a decrease in negative emotions after each session (p <0.05).

- during the chemotherapy infusion to reduce the symptoms related to the treatment or disease: A study evaluated the interest of VR by head-mounted display (Sony PC Glasstron PLM-S700) in 16 women aged 50 years and older during chemotherapy infusions. The symptoms such as anxiety and fatigue were assessed (STAI scale and revised Piper scale PFS). Patients were randomized to 2 chemotherapy sessions with the use of VR head-mounted display for one session and without stimulation for the other session. A decrease in anxiety immediately after the session was shown in this small number of patients (p = 0.10). On the other hand, there was no difference for fatigue but the study was carried out only on one session of RV.

It was showed a benefit of VR in 123 patients with breast, lung or colon cancer, receiving 2 chemotherapy sessions: participants were randomized according to a cross-over design in order to receive the VR intervention (by i-Glasses SVGA HeadMounted Display helmet) during one chemotherapy session and to receive during the other session no VR intervention (control arm), each patient being their own control. This technique was using a laptop, VR headset, and software. The Symptom Distress Scale was used to assess symptoms of distress immediately after the session and 48 hours after the session. No significant difference was found for the symptoms of distress between the session receiving the VR intervention and the session not receiving the intervention of VR. However, the study only assessed the use of VR over a single treatment session. The patients who received the VR technique had a decrease in anxiety during the initial session of chemotherapy (decrease of 3.34 points, p = 0.01). In addition, the perception of the time during the chemotherapy session was significantly altered, making the session more tolerable because it is shorter and thus validating the distraction capacity of this intervention.

When it comes to physical variables (vital signs), 4 studies found a significant difference in heart rate with a lower rate in the Virtual Reality group.

However, few studies in oncology have looked at non-isolating devices for VR (without helmet or glasses), therefore without excluding the patient from his environment. This non-isolating technology has also been considered as being able to offer the patient a more secure environment.

The purpose of this study is to assess the impact of this kind of stimulation during the intravenous treatment in patients with cancer.

研究类型

介入性

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Relaxing Visual Immersion
The patients will benefit a Relaxing Visual Immersion during the intravenous treatment for their cancer.
During the intravenous treatment for cancer, a nature movie will be projected on the ceiling of the room, along with natural sounds or a relaxing music. The patient will choose the movie or movies he wants to watch and can decide to stop the Relaxing Visual Immersion (RVI) at any time. The RVI is a system that does not isolate the patient from his familiar or medical entourage and which integrates virtual scenarios in the environment of care.
无干预:No sensitive stimulation
The patients will not receive Relaxing Visual Immersion during the intravenous treatment for their cancer.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Assess the impact of RVI on anxiety during the first intravenous cancer treatment session in cancer patients treated or not by anxiolytics
大体时间: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.
Baseline : first visit for intravenous anti-cancer treatment.

次要结果测量

结果测量
措施说明
大体时间
Assessment of pain felt.
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Using a visual analog scale.
Up to 2 years, during 3 anti-cancer treatment sessions.
Assessment of asthenia.
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Using the Piper's Revised Fatigue Scale.
Up to 2 years, during 3 anti-cancer treatment sessions.
Assessment of nausea.
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Using a visual analog scale.
Up to 2 years, during 3 anti-cancer treatment sessions.
Assessment of psychological distress.
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Using the Distress Thermometer Scale.
Up to 2 years, during 3 anti-cancer treatment sessions.
Assessment of the perception of elapsed time.
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Using a specific questionnaire designed for this study.
Up to 2 years, during 3 anti-cancer treatment sessions.
Assessment of the quality of patient - caregiver communication.
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Using a specific questionnaire designed for this study, for the caregiver point of view.
Up to 2 years, during 3 anti-cancer treatment sessions.
Assessment of the vital signs.
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Taking blood pressure before and after each treatment session.
Up to 2 years, during 3 anti-cancer treatment sessions.
Assessment of the vital signs.
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Taking cardiac rate before and after each treatment session.
Up to 2 years, during 3 anti-cancer treatment sessions.
Assessment of the undesirable effects linked to the RVI.
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Collection of the adverse events (drought eye, headache, dizziness).
Up to 2 years, during 3 anti-cancer treatment sessions.
Assessment of the anxiety.
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Using the State-Trait Anxiety Inventory (STAI).
Up to 2 years, during 3 anti-cancer treatment sessions.
Analysis of the taking anti-anxiety treatments during anti-cancer treatment session
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Harvesting prescribed doses of anxiolytics during anti-cancer treatment sessions.
Up to 2 years, during 3 anti-cancer treatment sessions.
Assessment of the quality of life.
大体时间:Up to 2 years, during 3 anti-cancer treatment sessions.
Using the QLQ-C30 questionnaire.
Up to 2 years, during 3 anti-cancer treatment sessions.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年9月1日

初级完成 (预期的)

2024年9月1日

研究完成 (预期的)

2024年9月1日

研究注册日期

首次提交

2020年7月29日

首先提交符合 QC 标准的

2020年8月25日

首次发布 (实际的)

2020年8月27日

研究记录更新

最后更新发布 (实际的)

2022年10月27日

上次提交的符合 QC 标准的更新

2022年10月25日

最后验证

2022年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • IMAVANX

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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