Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers
A Pilot Study Using a Cranial Electrotherapy Stimulation (CES) Device in Conjunction With Life Coaching to Alleviate Burnout Symptoms in HealthCare Workers (HCWs)
2 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2025
CompletedFirst Posted
Study publicly available on registry
May 18, 2025
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2026
Study Completion
Last participant's last visit for all outcomes
October 15, 2027
June 9, 2026
June 1, 2026
3 months
May 9, 2025
June 8, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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).
At baseline, 6 weeks, and 13 weeks
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.
At baseline, 6 weeks, and 13 weeks
Secondary Outcomes (2)
Self-reported resilience in HCWs
At baseline, 6 weeks, and 13 weeks
HCW self-reported probability of employment retention
At baseline, 6 weeks, and 13 weeks
Study Arms (2)
Arm I (Cranial Electrotherapy Stimulation (CES) + life coaching)
EXPERIMENTALDuring weeks 1-6, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also participate in virtual group life coaching sessions and discussions and view video assignments 3 times during weeks 1, 3, and 6. At week 7 participants will return their devices and receive their second device . During weeks 8-13 participants cross-over and use the sham device QD over 1 hour 5 days per week for 6 weeks on study.
Arm II (Sham device + life coaching sessions)
SHAM COMPARATORDuring weeks 1-6, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also participate in virtual group life coaching sessions and discussions and view video assignments 3 times during weeks 1, 3, and 6. At week 7, participants return their device and receive their second device. During weeks 8-13, participants cross-over and use the CES device QD over 1 hour 5 days per week for 6 weeks on study.
Interventions
Use CES device
Participate in discussions
Undergo coaching sessions
View video assignments
Undergo sham intervention
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
- Working on the Buffalo-Niagara Medical Campus (e.g. Roswell Park, Oishei Children's Hospital, Buffalo General, etc.)
- Ability to attend three (3) in-person appointments, one (1) hour in duration, at Roswell Park at week 1, week 6 and week 12 corresponding to the initial, midpoint, and final assessments
- Ability to use the CES daily for an hour each day
- Although the device is water-resistant, participants must agree to not use the device in the bath or shower
- Ability to read and write in English
- Participant has access to a computer with internet access and an email address
- Ability to attend three (3) virtual 60-minute group life coaching sessions, via Zoom
- Ability to complete three (3) 10-15-minute pre-recorded video assignments, which will be distributed via email (each assignment will be due by the end of the week that they are distributed)
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
You may not qualify if:
- 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.
- Unwilling or unable to follow protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Gallagher, PsyD
Roswell Park Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Researchers will be blinded with respect to subjects' study number, pre/post assessment data, and CES group (e.g., Group A versus Group B), the participants will remain blinded to which device they received (either sham or investigational device) throughout the duration of the study.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2025
First Posted
May 18, 2025
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
October 15, 2026
Study Completion (Estimated)
October 15, 2027
Last Updated
June 9, 2026
Record last verified: 2026-06