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Psychotraumatology in Somatic Medicine

Sponsor
Cantonal Hospital of St. Gallen (Other)
Overall Status
Completed
CT.gov ID
NCT05297435
Collaborator
(none)
200
Enrollment
1
Location
11.4
Actual Duration (Months)
17.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Psychotraumatology is clinically highly relevant, especially in the medical-somatic disciplines. Despite progress in recent decades, the clinical care is still inadequate - with unfavorable health effects for affected patients. There are avoidable burdens for involved clinicians and the health care system as a whole, also in terms of costs. With this background, our long-term project combines different research levels. Besides clarifying the clinical phenomenon, it aims to examine 1) the influence of traumatization on the physician-patient interaction as well as 2) the current psychological stress of the patients. Furthermore, 3) moderating factors on the side of the physicians, such as professional experience on the physician-patient interaction will be examined.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Questionnaires

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Psychotraumatology in Somatic Medicine - Gynecological Consultation
Actual Study Start Date :
Jan 19, 2021
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Dec 31, 2021

Outcome Measures

Primary Outcome Measures

  1. Quality of physician-patient relationship [Day 0]

    German version of the questionnaire "Patient Reactions Assessment Instruments" (PRA-D; Brenk-Franz et al., 2016)

Secondary Outcome Measures

  1. Early traumatization [Day 0]

    German version of the questionnaire "Childhood Trauma Questionnaire" (CTQ, Bernstein und Fink, 1998)

  2. Current traumatization [Day 0]

    German version of the questionnaire "Impact of Event Scale-Revised" (IES-R; Weiss & Marmar, 1997)

  3. Anxiety & Depression [Day 0]

    German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; Herrmann et al., 1995; Hermann-Lingen et al., 2011)

  4. Dissociative symptoms [Day 0]

    German questionnaire on dissociative symptoms (FDS-20; Spitzer et al., 2021)

  5. General distress [Day 0]

    German version of the questionnaire "distress thermometer" (BTH; Mehnert et al., 2006)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Inclusion Criteria:

  • At least 18 years old

  • Female patients of the preventive consultation of the gynecological clinic of the cantonal hospital St.Gallen

Exclusion Criteria:

  • Severe mental disorder (e.g. dissociative disorder)

  • Insufficient knowledge of German

Contacts and Locations

Locations

Site City State Country Postal Code
1 Katja Haemmerli Keller St.Gallen Switzerland 9007

Sponsors and Collaborators

  • Cantonal Hospital of St. Gallen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katja Haemmerli Keller, Dr. phil., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT05297435
Other Study ID Numbers:
  • 2020-02551
First Posted:
Mar 28, 2022
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Psychological Trauma

Study Results

No Results Posted as of Mar 28, 2022