Floatation Experience in Nurses and Physicians

May 5, 2025 updated by: C. Michael Dunham, Mercy Health Ohio

Wellbeing Monitoring During Sequential Reduced Environmental Stimulation-Floatation

The goal of this observational study is to monitor the floatation experience and continue the program as long as deemed important. The main question it aims to answer is: will inventory wellbeing scores increase according to the number of floatation sessions accrued? Nurses (registered, practitioner, and anesthetist) and physicians, employed at St. Elizabeth Youngstown Trauma Center, Mercy Health, will be welcomed to participate in the floatation experience. Participants will be given an option to complete the Wellbeing Inventory survey prior to each floatation session.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The floatation program is a Mercy Health enterprise sponsored by the Mercy Health Mahoning Valley Foundation.The goal of this study is to monitor the floatation experience and continue the program as long as deemed important. The investigators hypothesize that inventory wellbeing scores will increase according to the number of floatation sessions accrued. Nurses (registered, practitioner, and anesthetist) and physicians, employed at St. Elizabeth Youngstown Trauma Center, Mercy Health, will be welcomed to participate in the optional floatation program in Warren, Ohio at no financial cost to them. They will become aware of floatation options through the Mercy Health Be Well wellness program. Floatation monitoring will include assessments of wellbeing, nonstress, and positive affect scores. Participants will be given an option to complete the Wellbeing Inventory survey prior to each floatation session. This will be a self-reporting anonymous process. The investigator will never know the identity of the participant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Youngstown, Ohio, United States, 44501
        • St. Elizabeth Youngstown Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Nurses (registered, practitioner, and anesthetist) and physicians, employed at St. Elizabeth Youngstown Trauma Center, Mercy Health

Description

Inclusion Criteria:

  • Nurses and physicians

Exclusion Criteria:

  • Any person that is not a physician or nurse at St. Elizabeth Youngstown Hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Nurses and physicians
Nurses (registered, practitioner, and anesthetist) and physicians, employed at St. Elizabeth Youngstown Trauma Center, Mercy Health
Other: Reduced Environmental Stimulation Therapy
During floatation-REST (Reduced Environmental Stimulation Therapy), the participant enters a tank that is approximately 5 feet wide, 7 feet long and 5 feet high. The tank is filled with a 10 inch height of water containing enough Epsom salt (magnesium sulfate) to create body buoyancy. The water temperature is 93.5 degrees F, an approximate equivalent for normal skin temperature. Ear plugs are used to mitigate sound and the tank is without light illumination to prevent visual stimulation. The sessions are typically 60 minutes in duration. The individual is "Floating-in Solitude, Darkness, Silence, and Thermal-Neutrality." This experience reduces external sensory nervous system input and creates an extraordinarily deep state of mental and physical relaxation.
Other Names:
  • Floatation-REST

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the inventory wellbeing score
Time Frame: Through study completion, an average of 1 year
The sum of the positive affect and nonstress scores (range 11-55)
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the nonstress score
Time Frame: Through study completion, an average of 1 year
The sum of the reverse-scored ratings for the 7 negative affect items (range 7-35)
Through study completion, an average of 1 year
Change in the positive affect score
Time Frame: Through study completion, an average of 1 year
The sum of the ratings for the 4 positive affect items (range 4-20)
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mercy Health Ohio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: C. Michael Dunham, MD, Mercy Health Ohio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6120-810-1-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The wellbeing scores will be assessed according to the number of floatation sessions undertaken and described in a manuscript to be submitted to a peer-reviewed PubMed journal.

IPD Sharing Time Frame

Estimate that a descriptive manuscript will be developed and likely accepted for publication by December 2024.

IPD Sharing Access Criteria

Information will be shared through an open access publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wellbeing

Clinical Trials on Reduced Environmental Stimulation Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings