Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT05977894
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-08
First Post:
2023-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Floatation Experience in Nurses and Physicians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the inventory wellbeing score', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The sum of the positive affect and nonstress scores (range 11-55)'}], 'secondaryOutcomes': [{'measure': 'Change in the nonstress score', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The sum of the reverse-scored ratings for the 7 negative affect items (range 7-35)'}, {'measure': 'Change in the positive affect score', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The sum of the ratings for the 4 positive affect items (range 4-20)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Floatation', 'Anxiety', 'Attention', 'Awareness', 'Burnout', 'Relaxation Therapy', 'Self-concept', 'Wellbeing'], 'conditions': ['Burnout, Professional', 'Negative Affect', 'Positive Affect', 'Wellbeing', 'Burnout', 'Psychological']}, 'referencesModule': {'references': [{'pmid': '23129161', 'type': 'BACKGROUND', 'citation': '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': '24448053', 'type': 'BACKGROUND', 'citation': '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': '25250752', 'type': 'BACKGROUND', 'citation': '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': '20645421', 'type': 'BACKGROUND', 'citation': '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': '14734943', 'type': 'BACKGROUND', 'citation': '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': '16901488', 'type': 'BACKGROUND', 'citation': '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': '24047463', 'type': 'BACKGROUND', 'citation': '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': '17110646', 'type': 'BACKGROUND', 'citation': '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': '17762223', 'type': 'BACKGROUND', 'citation': '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': '27977605', 'type': 'BACKGROUND', 'citation': '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': '17185650', 'type': 'BACKGROUND', 'citation': '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': '26996364', 'type': 'BACKGROUND', 'citation': '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': '30906233', 'type': 'BACKGROUND', 'citation': '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': '28619081', 'type': 'BACKGROUND', 'citation': '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': '25023839', 'type': 'BACKGROUND', 'citation': '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': '29319643', 'type': 'BACKGROUND', 'citation': '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': '31208464', 'type': 'BACKGROUND', 'citation': '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': '29625870', 'type': 'BACKGROUND', 'citation': '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': '29656950', 'type': 'BACKGROUND', 'citation': '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': '36570829', 'type': 'BACKGROUND', 'citation': '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': '33123048', 'type': 'BACKGROUND', 'citation': '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': '8003591', 'type': 'BACKGROUND', 'citation': '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': '35389942', 'type': 'BACKGROUND', 'citation': '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': '11854763', 'type': 'BACKGROUND', 'citation': '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': '25344737', 'type': 'BACKGROUND', 'citation': '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': '29394251', 'type': 'BACKGROUND', 'citation': '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': '27016217', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nurses (registered, practitioner, and anesthetist) and physicians, employed at St. Elizabeth Youngstown Trauma Center, Mercy Health', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nurses and physicians\n\nExclusion Criteria:\n\n* Any person that is not a physician or nurse at St. Elizabeth Youngstown Hospital'}, 'identificationModule': {'nctId': 'NCT05977894', 'briefTitle': 'Floatation Experience in Nurses and Physicians', 'organization': {'class': 'OTHER', 'fullName': 'Mercy Health Ohio'}, 'officialTitle': 'Wellbeing Monitoring During Sequential Reduced Environmental Stimulation-Floatation', 'orgStudyIdInfo': {'id': '6120-810-1-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nurses and physicians', 'description': 'Nurses (registered, practitioner, and anesthetist) and physicians, employed at St. Elizabeth Youngstown Trauma Center, Mercy Health', 'interventionNames': ['Other: Reduced Environmental Stimulation Therapy']}], 'interventions': [{'name': 'Reduced Environmental Stimulation Therapy', 'type': 'OTHER', 'otherNames': ['Floatation-REST'], 'description': '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.', 'armGroupLabels': ['Nurses and physicians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44501', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'St. Elizabeth Youngstown Hospital', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}], 'overallOfficials': [{'name': 'C. Michael Dunham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mercy Health Ohio'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Estimate that a descriptive manuscript will be developed and likely accepted for publication by December 2024.', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'Information will be shared through an open access publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Health Ohio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Investigator', 'investigatorFullName': 'C. Michael Dunham', 'investigatorAffiliation': 'Mercy Health Ohio'}}}}