跳至主要内容
临床试验/NCT06378554
NCT06378554Enrolling By Invitation不适用

Cereset Research for Performance Improvement in a Hospital Nursing Unit

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
1
主要终点
Percent of ortho trauma unit staff who complete Cereset intervention

研究概览

简要总结

The purpose of this study is to explore whether an implementation process composed of offering CR to staff in a single hospital nursing unit has any potential impact on unit-level quality measures post-implementation.

详细描述

This is a pre-post design quality improvement project and implementation study, evaluating implementation measures, group level quality measures using QI methodology, and individual-level behavioral and performance measures before and after implementation of the Cereset Research (CR) evidence-based intervention among nursing unit staff. Individual-level behavioral symptoms and a nursing performance metric will be evaluated among healthcare workers in the nursing unit in the pre- and post-implementation timeframes among individuals who consent to participate in these evaluation activities. Up to 40 members of the unit will have the opportunity to enroll in the acoustic echoing neurostimulation intervention during the implementation timeframe. The neurostimulation intervention consists of 4 Cereset Research sessions of audible tones echoing current brainwave activity, and individual level behavioral symptoms will be collected following the last intervention session.

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
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to comply with basic instructions and be able to sit still, comfortably during sessions.
  • Healthcare worker in the Orthopedic Trauma Unit at Atrium Health Wake Forest Baptist, aged 18 years and older.

排除标准

  • Unable, unwilling, or incompetent to provide informed consent.
  • Physically unable to come to the study visits.
  • Severe hearing impairment (because CR involves acoustic stimulation that participants would need to be able to hear).
  • Weight is over the chair limit (400 pounds).
  • Currently enrolled in another Cereset Research study.
  • Use of the following modalities within one month before enrollment: electroconvulsive therapy (ECT), prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, eye movement desensitization and reprocessing (EMDR), brain spotting, neurofeedback, biofeedback, or deep brain stimulation (DBS). Individuals will be given the opportunity to discontinue these techniques for one month and then enroll.
  • Known seizure disorder.
  • Thoughts of active suicide within the last 3 months.

研究组 & 干预措施

Cereset Intervention Group

Active Comparator

This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM).

干预措施: Cereset Research (Device)

No Intervention

No Intervention

No Intervention

结局指标

主要结局

Percent of ortho trauma unit staff who complete Cereset intervention

时间窗: up to 2 years

Percent of ortho trauma unit staff who complete CR Intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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