A Pilot Study to Test the Acceptability and Feasibility o... | NCT05134155

Studies
A Pilot Study to Test the Acceptability and Feasibility of Relaxation Rooms to Help Reduce Occupational Stress Among Healthcare Workers

NCT05134155

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 16, 2023Actual

Enrollment

86Actual

Phase

Not provided

Conditions

Burn Out
Stress

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 26, 2022Actual

Primary Completion Date

Oct 27, 2022Actual

Completion Date

Oct 27, 2022Actual

First Submitted Date

Nov 14, 2021

First Submission Date that Met QC Criteria

Nov 23, 2021

First Posted Date

Nov 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2023

Last Update Posted Date

Mar 16, 2023Actual

Name	Class
Well Living Lab, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Test the acceptability and feasibility of a relaxation room to reduce work stress among clinicians and collect clinician-reported outcome data after using the relaxation room.

Detailed Description

The plan is to pilot test a relaxation room to demonstrate its acceptability and feasibility in the hospital and collect clinician-centered outcomes. This study will inform the design of a future trial using this intervention.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acceptability	the proportion of clinicians who found the MindBreaks room to be somewhat acceptable or acceptable	12 months

Secondary Outcomes

Measure	Description	Time Frame
Recruitment	the number recruited	12 months
Room Usage	how long participants stayed in the MindBreaks room	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinician at Mayo working at St. Mary's hospital or the downtown Rochester campus during the study

Exclusion Criteria:

Any physical condition that might prevent them from sitting for 20-30 minutes in the room
Significant hearing loss that they would not be able to hear the audio stimuli
Significant vision loss that they would not be able to see the visual stimuli

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Only clinicians at Mayo will be recruited as part of this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liselotte N Dyrbye, MD, MHPE	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D000077062	Burnout, Psychological

Ancestor Terms

ID	Term
D013315	Stress, Psychological
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided