Recruiting

Acute Stress

Sponsor:

Well Living Lab, Inc.

Code:

NCT05298189

Conditions

Stress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

MindBreaks - Audio-visual

MindBreaks - Auditory-only

MindBreaks - Visual-only

Study Details

Brief summary:

The proposed study aims to evaluate whether different features of a relaxation room affect how individuals recover from acute stress. This study will use a unique methodology to capture participants' physiological and behavioral measures through a combination of non-invasive technologies, including wearables devices, active sensors, cognitive tasks, and/or subjective questionnaires. Participants will perform a stress induction task, after which they will rest in a relaxation room. Physiological measures and cognitive performance will be recorded throughout the experiment to determine whether features of the relaxation room promote recovery after acute stress. Identifying the occurrence of stress and ways to potentially reduce the effects of stress could lead to novel interventions for helping individuals reduce work-related stress.

Conditions

Stress

Study ID

NCT05298189

Start date

Dec 2, 2021

Status verified date

Mar, 2022

Completion date

Jun 1, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Adults at least age 18
2. Participants are able to remain in the Well Living Lab for 3-4 hours
3. Participants are able to perform scripted tasks
4. Participants are able to provide informed consent
5. Participants are able to wear the wearable devices at all times during the study
6. Participants have completed a COVID vaccine regimen and can provide written documentation verifying vaccination status at least fourteen (14) days prior to the commencement of the research study

Exclusion Criteria:

1. Participants with a reported history of diagnosed mood, anxiety, or major health disorders
2. Participants who have used steroid-based medications within the past three years
3. Participants with a history of drug/alcohol abuse
4. Participants with or recovering from nicotine dependency who cannot use a nicotine patch
5. Participants who consume excessive amounts of caffeine
6. Participants who have had severe sleep disturbance (e.g., shift work, chronic insomnia)
7. Women who are pregnant or intend to become pregnant at the time of the study
8. Participants with a history of diagnosed cognitive impairment
9. Participants taking any medications that might affect the physiological measures of interest
10. Participants with anything that might affect collecting the physiological measures of interest (e.g., cosmetic products, head coverings, head products, etc.).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Audio-visual Group

experimental: Auditory-only Group

This group will recover in the relaxation room with only auditory stimuli.

experimental: Visual-only group

no intervention: Control Group

Interventions

MindBreaks - Audio-visual

A "MindBreaks" room is designed to deliver short, effective, and restorative breaks to help increase energy, reduce stress, enhance mood, improve focus, and boost performance. For this intervention, the MindBreaks room will contain visual and auditory stimuli.

MindBreaks - Auditory-only

A "MindBreaks" room is designed to deliver short, effective, and restorative breaks to help increase energy, reduce stress, enhance mood, improve focus, and boost performance. For this intervention, the MindBreaks room will contain only auditory stimuli.

MindBreaks - Visual-only

A "MindBreaks" room is designed to deliver short, effective, and restorative breaks to help increase energy, reduce stress, enhance mood, improve focus, and boost performance. For this intervention, the MindBreaks room will contain only visual stimuli.

Primary outcome measure

  • Change in cognitive performance relative to baseline [ Time Frame: throughout the one day experimental session at time points approximately -35 minutes, -5 minutes, +15 minutes, +35 minutes, +55 minutes relative to the start of the stress induction task ]
  • Change in perceived stress relative to baseline [ Time Frame: throughout the one day experimental session at time points approximately -35 minutes, -5 minutes, +5 minutes, +15 minutes, +35 minutes, +55 minutes relative to the start of the stress induction task ]
  • Change in heart rate relative to baseline [ Time Frame: throughout the one day experimental session during baseline (-35 minutes to -5 minutes), stress induction task (+0 to +15 minutes), recovery period #1 (+15 to +35 minutes), recovery period #2 (+35 to +55 minutes) epochs ]
  • Change in electroencephalography (EEG) alpha band power relative to baseline [ Time Frame: throughout the one day experimental session during baseline (-35 minutes to -5 minutes), stress induction task (+0 to +15 minutes), recovery period #1 (+15 to +35 minutes), recovery period #2 (+35 to +55 minutes) epochs ]

Central Contacts and Locations

Central contacts

Kevin A Mazurek, PhD

507-258-7592kevin.mazurek@delos.com

Locations

Well Living Lab Inc.

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Eric Heins

507-259-0611eric.heins@delos.com

Principal Investigator:

Colin P West, MD, Ph.D

More Information

Sponsor

Well Living Lab, Inc.

Last update posted

Mar 28, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Well Living Lab, Inc. on 2022-03-28.