- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02905071
Validation of a Scale of Well-being at Work (SERENAT)
Study of the Psychometric Properties of the Scale of Well-being at Work: The Serenat Study
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
This is a cross sectional survey. 200 subjects were selected among people having consulted an occupational doctor to validate the scale in the general population (study 1), and 50 subjects among a psychiatric population for the ancillary study (study 2).
The Serenat Scale is a self-report questionnaire composed of 20 items. All items are scored on a four point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree) resulting in a range of 0 to 60. The 20 items are related to different domains. 10 items explore psychological balance at work: relaxation (item 1), sleep quality (item 2), concentration (item 3), form (item 4), sense of security (item 5), satisfaction (item 6), quality of relationships and contacts at work (item 7), voltage or aggressiveness (item 8), optimism for the future from a professional point of view (item 9), life balance (item 10). 10 items are related to working conditions and organization of work: comfort of the working environment (item 11), time constraint (item 12), sense of competence (item 13), decision latitude (item 14), interest at work and variety of tasks (item 15), recognition (item 16), professional support (item 17), communication and transfer of information (item 18), human conflict (item 19), satisfactory work schedules (item 20).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
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Lille, Frankreich
- CHRU,Hôpital Fontan 2
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- agree to participate, exert a professional activity for at least 3 months at the time of inclusion, consult an occupational doctor or go to consultations related to stress and anxiety, read and be able to respond to the scale,
Exclusion Criteria:
- not be acting on work stoppage, nor pregnant, be capable of consent, not benefit from any legal protection regime and not be deprived of freedom.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Study 1 Group 1 G1 (n =50)
filling of Serenat at baseline (T1)
|
Patients who consult occupational doctor complete the serenat questionnaire.The time taken to complete the serenat scale is about 5 minutes.
Andere Namen:
|
Experimental: Study 1 Group 2 G2 (n=50)
Serenat at baseline T1 and 3 others questionnaires
|
Subjects who consult occupational doctor complete the 4 questionnaires.The time taken to complete the 4 questionnaires is about 15 minutes.
Andere Namen:
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Experimental: Study 1 Group 3 G3 (n =50)
filling of Serenat at baseline T1 and T2 (one week after baseline).
|
Patients who consult a psychiatrist in a stress anxiety unit complete the 4 questionnaires.
Andere Namen:
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Experimental: Study 2 Ancillary study (n=50)
filling of Serenat, HADS, STAY-Y and BDI at baseline T1
|
Subjects who consult occupational doctor complete the 4 questionnaires.The time taken to complete the 4 questionnaires is about 15 minutes.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Serenat scale
Zeitfenster: At baseline (T1)
|
For Group 1, Group 2, Group 3: The Serenat Scale is a self-report questionnaire composed of 20 items.
All items are scored on a four point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree) resulting in a range of 0 to 60.
The 20 items are related to different domains.
10 items explore psychological balance at work. 10 items are related to working conditions and organization of work.
|
At baseline (T1)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Serenat scale
Zeitfenster: one week after baseline (T2)
|
For Group 3: The Serenat Scale is a self-report questionnaire composed of 20 items.
All items are scored on a four point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree) resulting in a range of 0 to 60.
The 20 items are related to different domains.
10 items explore psychological balance at work. 10 items are related to working conditions and organization of work.
|
one week after baseline (T2)
|
Hospital Anxiety and Depression Scale (HADS)
Zeitfenster: At baseline (T1)
|
For group 2: The scale allows to detect anxiety and depression using 14 items rated from 0-3.
|
At baseline (T1)
|
State-Trait Anxiety inventory (STAI-Y)
Zeitfenster: At baseline (T1)
|
For Group: Self-administered questionnaire of 20 items side on 4 levels from 'not at all' to one side "many" side 4 (total score of 20-80).
It measures an intensity of more anxiety and is not related to an anxiety disorder
|
At baseline (T1)
|
The Beck depression inventory (BDI-21)
Zeitfenster: At baseline (T1)
|
For Group, Self-assessment questionnaire measuring the severity of depression
|
At baseline (T1)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Dominique SERVANT, MD, PhD, University Hospital, Lille
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Andrea H, Bultmann U, Beurskens AJ, Swaen GM, van Schayck CP, Kant IJ. Anxiety and depression in the working population using the HAD Scale--psychometrics, prevalence and relationships with psychosocial work characteristics. Soc Psychiatry Psychiatr Epidemiol. 2004 Aug;39(8):637-46. doi: 10.1007/s00127-004-0797-6.
- Stansfeld S, Candy B. Psychosocial work environment and mental health--a meta-analytic review. Scand J Work Environ Health. 2006 Dec;32(6):443-62. doi: 10.5271/sjweh.1050.
- Melchior M, Caspi A, Milne BJ, Danese A, Poulton R, Moffitt TE. Work stress precipitates depression and anxiety in young, working women and men. Psychol Med. 2007 Aug;37(8):1119-29. doi: 10.1017/S0033291707000414. Epub 2007 Apr 4.
- Servant D, Drumez E, Raynal S, Demarty AL, Salembier A, Deschepper MH, Bizet MA, Pisanu-Zimny A, Culem JB, Labreuche J, Duhamel A, Vaiva G. [Elaboration and psychometric properties of a well-being scale at work. The Serenat study among employees in occupational medicine unit]. Rev Epidemiol Sante Publique. 2019 Sep;67(5):303-309. doi: 10.1016/j.respe.2019.05.011. Epub 2019 Jun 28. French.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2012_63
- 2013-A00831-44 (Andere Kennung: ID-RDB number, ANSM)
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