Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorRoswell Park Cancer Institute

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Cranial Electrical Stimulation (CES)

    Procedure/Surgery

    Use CES device

  • Discussion

    Other intervention

    Participate in discussions

  • Health and Wellness Coach

    Behavioral

    Undergo coaching sessions

  • Informational Intervention

    Other intervention

    View video assignments

  • Sham Intervention

    Procedure/Surgery

    Undergo sham intervention

Treatment groups

40 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Cohort 1- Arm 1 (Cranial Electrotherapy Stimulation (CES) + life coaching)Experimental treatment 3 interventions
Group B: Cohort 1 -Arm II (Sham device + life coaching sessions)Sham comparator 4 interventions
Group C: Cohort 2 - Arm III - CES device + life coaching sessionsExperimental treatment 4 interventions
Group D: Cohort 2 - Arm IV (Sham device + life coaching sessionsSham comparator 4 interventions
Group E: Cohort 3, Arm V (CES device + life coaching sessions)Experimental treatment 3 interventions
Group F: Cohort 3, Arm VI (Sham-device + life coaching sessions)Sham comparator 3 interventions
Group G: Cohort 4, Arm VII (CES device + life coaching sessions)Experimental treatment 3 interventions
Group H: Cohort 4, Arm VIII (Sham device + life coaching sessions)Sham comparator 3 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
At baseline, 8 weeks, and 15 weeks
2

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.

Time frame
At baseline, 8 weeks, and 15 weeks

Secondary outcomes

1

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.

Time frame
At baseline, 8 weeks, and 15 weeks
2

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.

Time frame
At baseline, 8 weeks, and 15 weeks

Other outcomes

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