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PULS Study on Performance and Power of the Police and the University Hospital Ulm

Organizational Data

DRKS-ID:
DRKS00013288
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2021-05-26
Last update in DRKS:
2023-01-26
Registration type:
Retrospective

Acronym/abbreviation of the study

PULS Study

URL of the study

No Entry

Brief summary in lay language

Examination of police officers from specific areas of police service who are exposed to particular stress and development of ways to prevent trauma-related stress in the police service.

Brief summary in scientific language

Possibilities for prevention of traumatic strain in police service The aim of the present study is to investigate the association of mental and physical stress during service, individual ressources and psychophysiological parameters. Based on these parameters, it will be evaluated if prevention of high mental and physical stress represents a promising approach to sustainably enhance the work ability of police officers.

Health condition or problem studied

ICD10:
F43.1 - Post-traumatic stress disorder
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
a) Telephone screening, b) Clinic appointment (CAPS clinical interview, questionnaires & blood sampling), c) Long-term measurementPulse (24H), d) Consultation.

Endpoints

Primary outcome:
Heart rate variability (HRV): SDNN & RMSSD at first measurement timepoint
Secondary outcome:
Blood markers - Interleukin-6 [IL-6] - Adrenocorticotropic hormone [ACTH] - Glycohemoglobin [HbA1c] - Total cholesterol [LDL and HDL] - DHEA-S - fibrinogen - triglycerides - HS-CRP Collection via questionnaires (supplement): Physical activity Quality of life Sleep quality Acute stress experience Long-term stress Emotion regulation Anxiety symptoms Depressive symptoms Somatoform symptoms Occupational stress Psychological stress in the work context Coping with stress Psychosocial climate at work all at first measurement timepoint

Study Design

Purpose:
Prevention
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
Cross-sectional study
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik Für Psychosomatische Medizin Ulm

Recruitment period and number of participants

Planned study start date:
2021-04-12
Actual study start date:
2021-04-12
Planned study completion date:
No Entry
Actual Study Completion Date:
2022-06-30
Target Sample Size:
120
Final Sample Size:
120

Inclusion Criteria

Sex:
All
Minimum Age:
25 Years
Maximum Age:
55 Years
Additional Inclusion Criteria:
Active or former active professional occupation in an especially endangering field of work like: "Kriminaldauerdienst" (special team of the criminal investigation departement), police on patrol, road accident unit or day-service at the jurisdiction of the police headquarter Ulm.

Exclusion Criteria

Individuals with steroid therapy within 30 days before telephone screening. Individuals with heavy, chronic inflammatory and/or life-threatening diseases (e.g. heavy coronary heart diseases, cardiac insufficiency, incurable cancer, rheumatism), atrial fibrillation, pacemaker. Pregnancy.

Addresses

Primary Sponsor

Universitätsklinikum Ulm
Dr. Marc N. Jarczok
Albert Einstein Allee 21
89081 ULM
Germany
Telephone:
+4973150061810
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Ulm
Dr. Marc N. Jarczok
Albert-Einstein-Allee 23
89081 Ulm
Germany
Telephone:
+49 731 500 61810
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinikum Ulm
M. Sc. Christine Schillings
Albert-Einstein-Allee 23
89081 Ulm
Germany
Telephone:
+49 731 500 61904
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinikum Ulm
Dr. Marc N. Jarczok
Albert-Einstein-Allee 23
89081 Ulm
Germany
Telephone:
+49 731 500 61810
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Ministerium für Inneres, Digitalisierung und Migration Baden-Württemberg
Postfach 10 34 65
70029 Stuttgart
Germany
Telephone:
0711/231-4
Fax:
No Entry
Contact per E-Mail
URL:
https://im.baden-wuerttemberg.de/de/startseite/

Ethics Committee

Address Ethics Committee

Ethikkommission der Universität Ulm
Helmholtzstr. 20
89081 Ulm
Germany
Telephone:
+49-731-50022050
Fax:
+49-731-50022036
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2020-10-19
Ethics committee number:
403/20
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-02-10

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry