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临床试验/NCT06199050
NCT06199050已完成不适用

The Effect of 360° Virtual Reality Movies on Fear and Anxiety

Maastricht Radiation Oncology2 个研究点 分布在 1 个国家目标入组 292 人开始时间: 2023年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
292
试验地点
2
主要终点
Subjective fear, anxiety and stress (QSC-R23)

研究概览

简要总结

To assess the effect of web-based 360° Virtual Reality movies on fear and anxiety, The investigators would like to assess the patient-perceived level of fear and anxiety quantitatively, making use of several questionnaires.

详细描述

In ENGAGE, a KWF Samenloop Voor Hoop subsidized project, we have developed VR movies to reduce fear and anxiety for patients who are going to be treated at Maastro. These movies are based on where most fear and anxiety are experienced and have been developed after extensive discussion with different disciplines in patient care and with agreement of the Director Patient Care. The movies include: 1) Mouldroom, 2) VMDIBH mamma photons, 3) Head and Neck photons, 4) Lung photons, 5) CT-scan, 6) Prostate photons, and 7) Head and Neck/ Neuro protons. Currently, the web-based 360° movies are implemented in clinical practice and the VR glasses with the 360° movies will be used as soon as social work has decided on where to integrate the use in the care pathway.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
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

  • Diagnosed with breast- (only VMDIP), lung-, prostate-, head and neck cancer, a brain tumor.
  • Being able to speak, read and write in Dutch
  • General interview between radiation oncologist and patient (= Intake)
  • Ability to give written informed consent before the start of the study
  • Decision talk about start of treatment must have taken place

排除标准

  • Patients who are already receiving radiotherapy treatment
  • Pre-operative consultation for breast cancer patients
  • Patients who have seen the VR-videos already

结局指标

主要结局

Subjective fear, anxiety and stress (QSC-R23)

时间窗: 1 month

What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the Questionnaire on Stress in Cancer Patients revised version (QSC-R23). Dutch version of the Questionnaire on stress symptoms (QSC-R23) - 23 questions likert scale.

Subjective fear, anxiety and stress (SPIRIT)

时间窗: 1 month

What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the additional treatment-specific questions (SPIRIT). SPecifIc RadIation Treatment related questions (SPIRIT) - 10 questions likert scale

Relationship between fear, anxiety, stress experience, and answers given in the standard PROMS questionnaire

时间窗: 1 month

Is there a relationship between fear, anxiety, stress experience, and answers given to specific questions in the standard PROMS questionnaire. (e.g., the general quality of life questionnaire (EQ5D), especially on FEAR and DEPRESSION and health-related quality of life (SF-36)?)

Subjective fear, anxiety and stress (PROMS)

时间窗: 1 month

What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the Patient Reported Outcome Measures (PROMS) questionnaires. Patient reported outcome measures.

Subjective fear, anxiety and stress (HADS)

时间窗: 1 month

What is the subjective fear, anxiety, and stress experience of patients before radiation treatment, specifically for the eight different user cases for which VR-movies are present, using the Hospital Anxiety and Depression Scale (HADS). Hospital Anxiety and Depression Scale (HADS) - 14 questions likert scale

Relationship with demographics

时间窗: 1 month

Is there a relationship between fear, anxiety, stress experience, and the demographics of a patient.(I.e., prognosis, cancer indication, kind of treatment procedure)

次要结局

未报告次要终点

研究者

发起方
Maastricht Radiation Oncology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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