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临床试验/NCT05291533
NCT05291533已完成不适用

Patient Experiences With Virtual Reality Mindfulness Skills Training

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2022年5月6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
29
试验地点
1
主要终点
Change in composite score on Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson & Zwick, 1982)

研究概览

简要总结

This study aims to assess acceptability and preliminary efficacy of an intervention being administered clinically, a virtual reality (VR) mindfulness program. It is hypothesized that patients will find VR mindfulness an acceptable intervention and that it will reduce symptoms of anxiety.

详细描述

This pilot study proposes to assess acceptability and preliminary efficacy of an intervention being administered clinically, a virtual reality (VR) mindfulness program. Acceptability and preliminary efficacy will be determined by 1) patient feedback on their satisfaction with the intervention evaluated by the Client Satisfaction Questionnaire-8 (CSQ-8); 2) changes in acute subjective anxiety before and after using the program; 3) changes in subjective relaxation before and after using the program; 4) changes in global anxiety at referral to psychology and just prior to discharge; Any patient on units with access to this VR program who are referred for a psychological evaluation will have the opportunity to engage in the VR intervention.

Overall Design:

This study is an open trial evaluating the acceptability and efficacy of a VR mindfulness program being clinically implemented to address acute anxiety in patients admitted to medical and rehabilitation inpatient units.

VR Mindfulness Program:

Participants referred for a psychological or neuropsychological evaluation will have the opportunity to complete the study. A study staff member who is not the evaluating clinician will approach the patient to inquire about their interest in the study and conduct the informed consent process. Patients are typically referred for a psychological evaluation based on acute anxiety observed by staff or reported by the patient. The evaluating psychologist will collaborate with treatment team to make a clinical determination about whether VR mindfulness is indication (see exclusion criteria below). If it is determined that the patient could benefit from the VR intervention, a VR team member will facilitate the administration of a self-report measure on anxiety (GAD-7), obtain subjective ratings of anxiety and relaxation, and then administer the 5-minute VR mindfulness intervention. After patient's completion of the intervention, the VR team member will repeat the measures of subjective anxiety and relaxation. This procedure will be repeated as-needed (determined by clinical team) or up to three times per week based on patient preference and staff availability. The CSQ-8 will be administered after the patient's first use of VR mindfulness and again the day before discharge, if the patient opted to use repeatedly. The study team will re-administer the GAD-7 on the day prior to the patient's discharge.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Referred to psychology/neuropsychology
  • Identified by treatment team for use of VR mindfulness intervention
  • Able to provide informed consent or assent
  • Patient is over the age of 18

排除标准

  • Has not engaged in VR mindfulness intervention.
  • Determination by clinical team that patient cannot or would not benefit from participation in VR.
  • Reasons may include history of severe motion sickness or seizures, history of destruction of property, visual disturbance, vertigo, and cognitive impairment, delirium, and current or past diagnosis of a psychotic disorder

结局指标

主要结局

Change in composite score on Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson & Zwick, 1982)

时间窗: Immediately after first intervention (use of VR) and at hospital discharge an average of 10 days later

An 8-item, empirically validated measure of satisfaction with a clinical program. Scores therefore range from 8 to 32, with lower values indicating lower satisfaction and higher values indicating higher satisfaction.

次要结局

  • Mean change in General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006) from baseline to discharge(Immediately before first intervention (use of VR) and at hospital discharge an average of 10 days later)
  • Mean change in Subject Units of Distress (SUDS) from pre- to post-VR(Immediately before and after each intervention (use of VR), up to two times per week for duration of hospital stay (average 10 days))
  • Mean change in Subjective units of relaxation from pre-to post-VR(Immediately before and after each intervention (use of VR), up to two times per week for duration of hospital stay (average 10 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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