跳至主要内容
临床试验/NCT05135260
NCT05135260已完成不适用

The Effects of Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic

Cody Stansel2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2021年11月1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
99
试验地点
2
主要终点
Positive or negative effect of Virtual Reality therapy on improving the experience of participants receiving chemotherapy

研究概览

简要总结

This study will investigate the ability of virtual reality to function as a novel distraction intervention and improve the experience of patients who are receiving chemotherapy in the infusion clinic.

详细描述

Objectives:

Primary Objective:

  • To deploy and evaluate virtual reality as an intervention for stress, pain, and negative affect

Secondary Objective:

  • To evaluate cyber sickness and patient satisfaction related to the virtual reality treatment

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
Single (Participant)

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

  • At or above the age of 18
  • English Speaking
  • Diagnosed with cancer
  • No previous history of seizures, losses of awareness, or other symptoms linked to an epileptic condition
  • Not sensitive to motion sickness
  • Not currently experiencing any contagious conditions, infections, or diseases (particularly of the eyes, skin, or scalp)
  • Does not use a device to regulate heart rate or rhythm (such as a pacemaker)
  • Not taking antiarrhythmic medications
  • Not actively receiving radiopharmaceutical therapy
  • To ensure that there is sufficient time to complete the virtual reality treatment, patients who are scheduled for visits for periods of less than one hour will not be included in this study. Additionally, patients must consent to participating in the study on the day of the experience.
  • Patients who are asleep prior to consenting will not be asked to participate in the study

排除标准

  • 未提供

结局指标

主要结局

Positive or negative effect of Virtual Reality therapy on improving the experience of participants receiving chemotherapy

时间窗: Approximately 12 months

Measured by the Positive and Negative Affect Scale (0=minimum to 5=maximum). Consisting of a number of words that describe different feelings and emotions. Patients are instructed to indicate to what extent they currently feel each of the feelings or emotions. Afterwards, patient responses are scored to produce a numerical positive affect score and a negative affect score.

Measure the affect of Virtual Reality Therapy on improving stress

时间窗: Approximately 12 months

Measured by stress level using the stress numerical rating

Measure the affect of Virtual Reality Therapy on improving pain

时间窗: Approximately 12 months

Measured by pain level using the pain numerical score (scale 0 (none) to 10 (worst)

次要结局

  • Rate of cyber sickness (Virtual Reality Therapy Arm Only)(Approximately 12 months)

研究者

发起方
Cody Stansel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cody Stansel

Principal Investigator

Vanderbilt-Ingram Cancer Center

研究点 (2)

Loading locations...

相似试验