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 Feb 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
February 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2027
ExpectedSeptember 9, 2026
September 1, 2026
8 months
May 9, 2025
September 3, 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, 8 weeks, and 15 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, 8 weeks, and 15 weeks
Secondary Outcomes (2)
Self-reported resilience in HCWs
At baseline, 8 weeks, and 15 weeks
HCW self-reported probability of employment retention
At baseline, 8 weeks, and 15 weeks
Study Arms (8)
Cohort 1- Arm 1 (Cranial Electrotherapy Stimulation (CES) + life coaching)
EXPERIMENTALDevices received during week 1. During weeks 2-7, 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 during weeks 3, 5, and 7 and view video assignments 3 times during weeks 2,4 and 6. Participants cross-over and exchange their device at week 8 . During weeks 9-14 participants cross-over and use the sham device QD over 1 hour 5 days per week for 6 weeks on study.
Cohort 1 -Arm II (Sham device + life coaching sessions)
SHAM COMPARATORDevices received during week 1. During weeks 2-7, 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 during weeks 3, 5, and 7 and view video assignments 3 times during weeks 2, 4 and 6.. At week 8 participants cross over and exchange their device and receive their second device. During weeks 9-14, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study.
Cohort 2 - Arm III - CES device + life coaching sessions
EXPERIMENTALParticipants receive their devices during week 9. During weeks 10-15, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 11, 13, and 15 and view video assignments 3 times during weeks 10, 12, and 14. Participants cross-over and exchange their devices at week 16. During weeks 7-22, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study.
Cohort 2 - Arm IV (Sham device + life coaching sessions
SHAM COMPARATORParticipants receive their devices during week 9. During weeks 10-15, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 11, 13, and 15 and view video assignments 3 times during weeks 10, 12, and 14. Participants cross-over and exchange their devices at week 16. During weeks 7-22, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study
Cohort 3, Arm V (CES device + life coaching sessions)
EXPERIMENTALParticipants receive their devices during week 17. During weeks 18-23, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 19, 21, and 23 and view video assignments 3 times during weeks 18, 20, and 22. Participants cross-over and exchange their devices at week 24. During weeks 25-30, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study
Cohort 3, Arm VI (Sham-device + life coaching sessions)
SHAM COMPARATORParticipants receive their devices during week 17. During weeks 18-23, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 19, 21, and 23 and view video assignments 3 times during weeks 18, 20, and 22. Participants cross-over and exchange their devices at week 24. During weeks 25-30, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study.
Cohort 4, Arm VII (CES device + life coaching sessions)
EXPERIMENTALParticipants receive their devices during week 25. During weeks 26-31, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 27, 29, and 31 and view video assignments 3 times during weeks 26, 28, and 30. Participants cross-over and exchange their devices at week 32. During weeks 33-38, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study.
Cohort 4, Arm VIII (Sham device + life coaching sessions)
SHAM COMPARATORParticipants receive their devices during week 25. During weeks 26-31, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 27, 29, 31 and view video assignments 3 times during weeks 26, 28, 30. Participants cross-over and exchange their devices at week 32. During weeks 33-38, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study.
Interventions
Participate in discussions
Undergo coaching sessions
Use CES device
View video assignments
Undergo sham intervention
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
- 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
- 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 occuring Mondays at 6:30pm EST, 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
February 4, 2026
Primary Completion
October 4, 2026
Study Completion (Estimated)
October 4, 2027
Last Updated
September 9, 2026
Record last verified: 2026-09