NCT05977894

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 28, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Completed
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

July 12, 2023

Last Update Submit

May 5, 2025

Conditions

Keywords

FloatationAnxietyAttentionAwarenessBurnoutRelaxation TherapySelf-conceptWellbeing

Outcome Measures

Primary Outcomes (1)

  • Change in the inventory wellbeing score

    The sum of the positive affect and nonstress scores (range 11-55)

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Change in the nonstress score

    Through study completion, an average of 1 year

  • Change in the positive affect score

    Through study completion, an average of 1 year

Study Arms (1)

Nurses and physicians

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

Other: Reduced Environmental Stimulation Therapy

Interventions

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.

Also known as: Floatation-REST
Nurses and physicians

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Nurses and physicians

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501, United States

Location

Related Publications (27)

  • Dyrbye LN, Satele D, Sloan J, Shanafelt TD. Utility of a brief screening tool to identify physicians in distress. J Gen Intern Med. 2013 Mar;28(3):421-7. doi: 10.1007/s11606-012-2252-9. Epub 2012 Nov 6.

    PMID: 23129161BACKGROUND
  • Dyrbye LN, West CP, Satele D, Boone S, Tan L, Sloan J, Shanafelt TD. Burnout among U.S. medical students, residents, and early career physicians relative to the general U.S. population. Acad Med. 2014 Mar;89(3):443-51. doi: 10.1097/ACM.0000000000000134.

    PMID: 24448053BACKGROUND
  • Brazeau CM, Shanafelt T, Durning SJ, Massie FS, Eacker A, Moutier C, Satele DV, Sloan JA, Dyrbye LN. Distress among matriculating medical students relative to the general population. Acad Med. 2014 Nov;89(11):1520-5. doi: 10.1097/ACM.0000000000000482.

    PMID: 25250752BACKGROUND
  • Poghosyan L, Clarke SP, Finlayson M, Aiken LH. Nurse burnout and quality of care: cross-national investigation in six countries. Res Nurs Health. 2010 Aug;33(4):288-98. doi: 10.1002/nur.20383.

    PMID: 20645421BACKGROUND
  • Vahey DC, Aiken LH, Sloane DM, Clarke SP, Vargas D. Nurse burnout and patient satisfaction. Med Care. 2004 Feb;42(2 Suppl):II57-66. doi: 10.1097/01.mlr.0000109126.50398.5a.

    PMID: 14734943BACKGROUND
  • Chang EM, Bidewell JW, Huntington AD, Daly J, Johnson A, Wilson H, Lambert VA, Lambert CE. A survey of role stress, coping and health in Australian and New Zealand hospital nurses. Int J Nurs Stud. 2007 Nov;44(8):1354-62. doi: 10.1016/j.ijnurstu.2006.06.003. Epub 2006 Aug 9.

    PMID: 16901488BACKGROUND
  • Lindqvist R, Smeds Alenius L, Griffiths P, Runesdotter S, Tishelman C. Structural characteristics of hospitals and nurse-reported care quality, work environment, burnout and leaving intentions. J Nurs Manag. 2015 Mar;23(2):263-74. doi: 10.1111/jonm.12123. Epub 2013 Sep 19.

    PMID: 24047463BACKGROUND
  • Poncet MC, Toullic P, Papazian L, Kentish-Barnes N, Timsit JF, Pochard F, Chevret S, Schlemmer B, Azoulay E. Burnout syndrome in critical care nursing staff. Am J Respir Crit Care Med. 2007 Apr 1;175(7):698-704. doi: 10.1164/rccm.200606-806OC. Epub 2006 Nov 16.

    PMID: 17110646BACKGROUND
  • Embriaco N, Papazian L, Kentish-Barnes N, Pochard F, Azoulay E. Burnout syndrome among critical care healthcare workers. Curr Opin Crit Care. 2007 Oct;13(5):482-8. doi: 10.1097/MCC.0b013e3282efd28a.

    PMID: 17762223BACKGROUND
  • Chuang CH, Tseng PC, Lin CY, Lin KH, Chen YY. Burnout in the intensive care unit professionals: A systematic review. Medicine (Baltimore). 2016 Dec;95(50):e5629. doi: 10.1097/MD.0000000000005629.

    PMID: 27977605BACKGROUND
  • Mealer ML, Shelton A, Berg B, Rothbaum B, Moss M. Increased prevalence of post-traumatic stress disorder symptoms in critical care nurses. Am J Respir Crit Care Med. 2007 Apr 1;175(7):693-7. doi: 10.1164/rccm.200606-735OC. Epub 2006 Dec 21.

    PMID: 17185650BACKGROUND
  • Abdo SA, El-Sallamy RM, El-Sherbiny AA, Kabbash IA. Burnout among physicians and nursing staff working in the emergency hospital of Tanta University, Egypt. East Mediterr Health J. 2016 Mar 15;21(12):906-15. doi: 10.26719/2015.21.12.906.

    PMID: 26996364BACKGROUND
  • Alqahtani AM, Awadalla NJ, Alsaleem SA, Alsamghan AS, Alsaleem MA. Burnout Syndrome among Emergency Physicians and Nurses in Abha and Khamis Mushait Cities, Aseer Region, Southwestern Saudi Arabia. ScientificWorldJournal. 2019 Feb 18;2019:4515972. doi: 10.1155/2019/4515972. eCollection 2019.

    PMID: 30906233BACKGROUND
  • Hamdan M, Hamra AA. Burnout among workers in emergency Departments in Palestinian hospitals: prevalence and associated factors. BMC Health Serv Res. 2017 Jun 15;17(1):407. doi: 10.1186/s12913-017-2356-3.

    PMID: 28619081BACKGROUND
  • Hinderer KA, VonRueden KT, Friedmann E, McQuillan KA, Gilmore R, Kramer B, Murray M. Burnout, compassion fatigue, compassion satisfaction, and secondary traumatic stress in trauma nurses. J Trauma Nurs. 2014 Jul-Aug;21(4):160-9. doi: 10.1097/JTN.0000000000000055.

    PMID: 25023839BACKGROUND
  • Munnangi S, Dupiton L, Boutin A, Angus LDG. Burnout, Perceived Stress, and Job Satisfaction Among Trauma Nurses at a Level I Safety-Net Trauma Center. J Trauma Nurs. 2018 Jan/Feb;25(1):4-13. doi: 10.1097/JTN.0000000000000335.

    PMID: 29319643BACKGROUND
  • Dunham CM, Burger AL, Hileman BM, Chance EA. Psychometric properties of the St. Elizabeth Youngstown hospital wellbeing inventory and non-burnout inventory for physicians and nurses. BMC Psychol. 2019 Jun 17;7(1):36. doi: 10.1186/s40359-019-0316-x.

    PMID: 31208464BACKGROUND
  • Kim HS, Yeom HA. The association between spiritual well-being and burnout in intensive care unit nurses: A descriptive study. Intensive Crit Care Nurs. 2018 Jun;46:92-97. doi: 10.1016/j.iccn.2017.11.005. Epub 2018 Apr 3.

    PMID: 29625870BACKGROUND
  • Feinstein JS, Khalsa SS, Yeh H, Al Zoubi O, Arevian AC, Wohlrab C, Pantino MK, Cartmell LJ, Simmons WK, Stein MB, Paulus MP. The Elicitation of Relaxation and Interoceptive Awareness Using Floatation Therapy in Individuals With High Anxiety Sensitivity. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jun;3(6):555-562. doi: 10.1016/j.bpsc.2018.02.005. Epub 2018 Mar 9.

    PMID: 29656950BACKGROUND
  • Flux MC, Fine TH, Poplin T, Al Zoubi O, Schoenhals WA, Schettler J, Refai HH, Naegele J, Wohlrab C, Yeh HW, Lowry CA, Levine JC, Smith R, Khalsa SS, Feinstein JS. Exploring the acute cardiovascular effects of Floatation-REST. Front Neurosci. 2022 Dec 9;16:995594. doi: 10.3389/fnins.2022.995594. eCollection 2022.

    PMID: 36570829BACKGROUND
  • Khalsa SS, Moseman SE, Yeh HW, Upshaw V, Persac B, Breese E, Lapidus RC, Chappelle S, Paulus MP, Feinstein JS. Reduced Environmental Stimulation in Anorexia Nervosa: An Early-Phase Clinical Trial. Front Psychol. 2020 Oct 6;11:567499. doi: 10.3389/fpsyg.2020.567499. eCollection 2020.

    PMID: 33123048BACKGROUND
  • Schulz P, Kaspar CH. Neuroendocrine and psychological effects of restricted environmental stimulation technique in a flotation tank. Biol Psychol. 1994 Mar;37(2):161-75. doi: 10.1016/0301-0511(94)90029-9.

    PMID: 8003591BACKGROUND
  • Caldwell LK, Kraemer WJ, Post EM, Volek JS, Focht BC, Newton RU, Hakkinen K, Maresh CM. Acute Floatation-REST Improves Perceived Recovery After a High-Intensity Resistance Exercise Stress in Trained Men. Med Sci Sports Exerc. 2022 Aug 1;54(8):1371-1381. doi: 10.1249/MSS.0000000000002906. Epub 2022 Apr 6.

    PMID: 35389942BACKGROUND
  • Kjellgren A, Sundequist U, Norlander T, Archer T. Effects of flotation-REST on muscle tension pain. Pain Res Manag. 2001 Winter;6(4):181-9. doi: 10.1155/2001/768501.

    PMID: 11854763BACKGROUND
  • Kjellgren A, Westman J. Beneficial effects of treatment with sensory isolation in flotation-tank as a preventive health-care intervention - a randomized controlled pilot trial. BMC Complement Altern Med. 2014 Oct 25;14:417. doi: 10.1186/1472-6882-14-417.

    PMID: 25344737BACKGROUND
  • Feinstein JS, Khalsa SS, Yeh HW, Wohlrab C, Simmons WK, Stein MB, Paulus MP. Examining the short-term anxiolytic and antidepressant effect of Floatation-REST. PLoS One. 2018 Feb 2;13(2):e0190292. doi: 10.1371/journal.pone.0190292. eCollection 2018.

    PMID: 29394251BACKGROUND
  • Jonsson K, Kjellgren A. Promising effects of treatment with flotation-REST (restricted environmental stimulation technique) as an intervention for generalized anxiety disorder (GAD): a randomized controlled pilot trial. BMC Complement Altern Med. 2016 Mar 25;16:108. doi: 10.1186/s12906-016-1089-x.

    PMID: 27016217BACKGROUND

MeSH Terms

Conditions

Burnout, ProfessionalBurnout, PsychologicalAnxiety Disorders

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • C. Michael Dunham, MD

    Mercy Health Ohio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Investigator

Study Record Dates

First Submitted

July 12, 2023

First Posted

August 7, 2023

Study Start

October 28, 2023

Primary Completion

May 5, 2026

Study Completion

May 5, 2026

Last Updated

May 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Estimate that a descriptive manuscript will be developed and likely accepted for publication by December 2024.
Access Criteria
Information will be shared through an open access publication.

Locations