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临床试验/NCT06045741
NCT06045741已完成不适用

Virtual Reality - A New Vision on Pain

Sykehuset i Vestfold HF1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
PROMIS Pain interference

研究概览

简要总结

The purpose of the project is to investigate if the use of virtual reality (VR) technology with pre-programmed proprietary software can provide better treatment for patients with long-term pain conditions. This is investigated in this pilot study conducted on patients referred to outpatient treatment at the Division of Physical Medicine and Rehabilitation. The pilot study will lay the foundation for a follow-up study (RCT). The effect of VR are evaluated by patient reporting forms; before start-up and 3 months after startup. Patients included in the study receive standard treatment supplemented with the use of VR technology.

The therapists involved will be Interviewed to examine their experiences with the use of the VR-technology in the treatment of patients.

VR technology can potentially contribute to better treatment (e.g. measured in outcomes such as activity, sleep problems, pain intensity, quality of life). Moreover we expect that a VR-assisted treatment to be more cost-effective and increased availability regardless of geography and demography.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • pain duration > 3 moths
  • Master Norwegian spoken language

排除标准

  • History of malignant disease
  • pain duration < 3 Months
  • Does not master Norwegian spoken language

结局指标

主要结局

PROMIS Pain interference

时间窗: Three months

Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.

PROMIS Pain intensity

时间窗: Three months

Numeric rating scale (NRS (0-10)) How much a person hurts

次要结局

  • EQ-5D-5L(Three months)
  • PROMIS Emotional Distress - Depression(Three months)
  • PROMIS Physical Health - Sleep Disturbance(Three months)
  • PROMIS Physical Health - Fatigue(Three months)
  • PROMIS Physical Function(Three months)
  • System Usability Scale (SUS)(Three months)
  • PROMIS Emotional Distress - Anxiety(Three months)
  • PROMIS Social Health - Ability to Participate in Social Roles and Activities(Three months)
  • RTWSE-11 Return ti work self efficacy(Three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Inge Ringheim

PhD

Sykehuset i Vestfold HF

研究点 (1)

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