About this trial
This clinical trial evaluates the effect of life coaching together with Cranial Electrotherapy Stimulation (CES) as an intervention to decrease self-reported symptoms of burnout, moral distress, resilience, and employee retention in oncology healthcare workers. Burnout and moral distress are occupational hazards for oncology healthcare workers. Emotional exhaustion, depersonalization, and lack of personal accomplishment at work are symptoms of burnout. Moral distress may be defined as knowing the right thing to do but being unable to do so based upon internal or external constraints. The device is attached to the earlobes that uses cranial electrotherapy stimulation (CES) at a microcurrent to alleviate symptoms of anxiety, insomnia, pain, and possibly depression. Life coaching is partnering with clients in a thought-provoking and creative process that inspires them to maximize their personal and professional potential and can increase resiliency skills such as boundary setting and prioritizing, increases in self-compassion and self-care, and potentially indirectly positively impact patient care. Undergoing the use of CES via the CES device, coupled with life coaching, may help alleviate burnout symptoms and moral distress in oncology healthcare workers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 21 ≤ and ≤ 75 years old
Patient-facing healthcare workers (e.g., medical doctor, advanced practice provider, nurse)
Experiencing symptoms of burnout, as defined by a score of 1, 2, or 3 on question #2 of the Mini-Z II Survey
Ability to attend three (3) in-person appointments, one (1) hour in duration, at Roswell Park at week 1, week 6 and week 15 corresponding to the initial, midpoint, and final assessments
Disqualifiers
Subjects who self-report as pregnant or nursing. Pregnancy be verified with a urine test for all persons of childbearing potential with a uterus
Subjects with a self-reported history of the following: Meniere's disease, history of vertigo or prone to dizziness, seizure disorder, pacemaker / implantable cardioverter-defibrillator (automatic implantable cardioverter defibrillator [AICD]), cochlear implant, or any implanted electrical devices that cannot be shut off
Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit.
Any self-reported medical or psychiatric condition which in the PI or study physician's opinion deems the participant an unsuitable candidate to participate in this trial.
Trial design
Crossover
Treatments tested in this trial
Cranial Electrical Stimulation (CES)
Procedure/SurgeryUse CES device
Discussion
Other interventionParticipate in discussions
Health and Wellness Coach
BehavioralUndergo coaching sessions
Informational Intervention
Other interventionView video assignments
Sham Intervention
Procedure/SurgeryUndergo sham intervention
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Symptoms of burnout in healthcare workers (HCWs)
Will be assessed using the Mini-Z Survey. Will be summarized by study arm and time-point (baseline, midpoint, and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. The Mini-Z scores will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using linear mixed models (LMMs).
Symptoms of moral distress in HCWs
Will be assessed using the Measure of Moral Distress for Healthcare Workers (MMDHW). Will be summarized by study arm and time-point (baseline, midpoint, and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. The MMDHW scores will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using LMMs.
Secondary outcomes
Self-reported resilience in HCWs
Measure of resilience will be assessed using the Brief Resilient Coping Scale. Will be summarized by study arm and time-point (baseline and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. Will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using LMMs.
HCW self-reported probability of employment retention
Likelihood of employment retention will be assessed using the Organizational Wellbeing Assessment - Retention. Will be summarized by study arm and time-point (baseline and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. Will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using LMMs.
Sponsors and contacts
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