Clinical trial NCT06378554: Cereset Research for Performance Improvement in a Hospital Nursing Unit
Official title: Cereset Research for Performance Improvement in a Hospital Nursing Unit
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Health Personnel
Stress
Anxiety
Insomnia
Depression
Keywords: Anxiety
Stress
Insomnia
Cereset Research
Brain electrical activity
Neurotechnology
HIRREM
Neuromodulation
Acoustic stimulation
Healthcare Worker
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: The Susanne Marcus Collins Foundation, Inc.
First posted: 2024-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percent of ortho trauma unit staff who complete Cereset intervention
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles H Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
References: