Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT06977503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
A Pilot Study Using a Cranial Electrotherapy Stimulation (CES) Device in Conjunction With Life Coaching to Alleviate Burnout Symptoms in HealthCare Workers (HCWs)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the efficacy of using Cranial Electrotherapy Stimulation (CES) with group life coaching sessions as an intervention to decrease healthcare worker self-reported symptoms of burnout and moral distress.
SECONDARY OBJECTIVE:
I. To determine the efficacy of using Cranial Electrotherapy Stimulation (CES) with group life coaching sessions as a supportive intervention to increase healthcare worker self-reported ratings of resilience, and employment retention (Organizational Wellbeing Assessment - Retention \[OWA-R\]).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: During weeks 1-6, participants use the CES device once daily (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. During weeks 7-12, participants cross-over and use the sham device QD over 1 hour 5 days per week for 6 weeks on study.
ARM II: During 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. During weeks 7-12, participants cross-over and use the CES device QD over 1 hour 5 days per week for 6 weeks on study.
I. To determine the efficacy of using Cranial Electrotherapy Stimulation (CES) with group life coaching sessions as an intervention to decrease healthcare worker self-reported symptoms of burnout and moral distress.
SECONDARY OBJECTIVE:
I. To determine the efficacy of using Cranial Electrotherapy Stimulation (CES) with group life coaching sessions as a supportive intervention to increase healthcare worker self-reported ratings of resilience, and employment retention (Organizational Wellbeing Assessment - Retention \[OWA-R\]).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: During weeks 1-6, participants use the CES device once daily (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. During weeks 7-12, participants cross-over and use the sham device QD over 1 hour 5 days per week for 6 weeks on study.
ARM II: During 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. During weeks 7-12, participants cross-over and use the CES device QD over 1 hour 5 days per week for 6 weeks on study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: