Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
76 participants
INTERVENTIONAL
2022-02-09
2023-05-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.
NCT02690194
Interactive Effects of Mindfulness and Slow-paced Breathing
NCT04866901
Stress Management in College Students
NCT05392621
Promoting Stress Management and Engagement in Introductory Physics Courses with Mindfulness and Relaxation
NCT05542498
Stress Reduction: A Pilot Study With Adolescents
NCT02629016
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
tVNS + mindfulness
Transcutaneous vagus nerve stimulation plus behavioral: mindfulness
tVNS
transcutaneous vagus nerve stimulation
Mindfulness
Brightmind mobile mindfulness application
Sham + mindfulness
Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Mindfulness
Brightmind mobile mindfulness application
sham tVNS
sham transcutaneous vagus nerve stimulation
Mindfulness only
Mindfulness
Brightmind mobile mindfulness application
Control
Control number puzzle task delivered via mobile device
Number Puzzle
Control number puzzle task delivered via mobile device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tVNS
transcutaneous vagus nerve stimulation
Mindfulness
Brightmind mobile mindfulness application
sham tVNS
sham transcutaneous vagus nerve stimulation
Number Puzzle
Control number puzzle task delivered via mobile device
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must own a smartphone
* Must be able to read and write English
Exclusion Criteria
* Pregnancy
* History of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices
* History of adverse reaction to electrical nerve stimulation
* Prescribed sleep medications and/or psychotropic medications
* Illicit or prescription drug abuse within the last two months (marijuana or alcohol abuse \>2 weeks out will be acceptable for inclusion)
18 Years
30 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Florida
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sarah Bottari, M.S.
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Liva LaMontagne, Dr. Psych.
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Florida
Gainesville, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB202101724
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.