This trial studies how well the Cereset intervention works in relieving stress in caregivers of patients with glioma. Cereset is a stress-relaxation treatment where sounds are used that help to balance brain rhythms. The purpose of this study is to see if caregivers of patients with brain tumors will use the device and see how it might relieve stress and anxiety in caregivers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03935269.
PRIMARY OBJECTIVE:
I. To determine the feasibility of completing the prescribed Cereset Research Office intervention for trial participants in this single arm, open label study.
SECONDARY OBJECTIVES:
I. To assess the tolerability of the intervention.
II. To assess changes in trial participant wellbeing and quality of life.
III. To assess changes in physiological response at pre-intervention and post-intervention time points.
EXPLORATORY OBJECTIVE:
I. To assess the trial participant acceptability of the Cereset Research intervention.
OUTLINE:
Caregivers undergo Cereset Research Office session in an office setting for 5 sessions over 1-1.5 hour each.
After completion of study, participants are followed up for 10-12 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorRoy Ervin Strowd