Psychotraumatology in Somatic Medicine

March 25, 2022 updated by: Katja Haemmerli Keller, Cantonal Hospital of St. Gallen

Psychotraumatology in Somatic Medicine - Gynecological Consultation

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • St.Gallen, Switzerland, 9007
        • Katja Haemmerli Keller

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of physician-patient relationship
Time Frame: Day 0
German version of the questionnaire "Patient Reactions Assessment Instruments" (PRA-D; Brenk-Franz et al., 2016)
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early traumatization
Time Frame: Day 0
German version of the questionnaire "Childhood Trauma Questionnaire" (CTQ, Bernstein und Fink, 1998)
Day 0
Current traumatization
Time Frame: Day 0
German version of the questionnaire "Impact of Event Scale-Revised" (IES-R; Weiss & Marmar, 1997)
Day 0
Anxiety & Depression
Time Frame: Day 0
German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; Herrmann et al., 1995; Hermann-Lingen et al., 2011)
Day 0
Dissociative symptoms
Time Frame: Day 0
German questionnaire on dissociative symptoms (FDS-20; Spitzer et al., 2021)
Day 0
General distress
Time Frame: Day 0
German version of the questionnaire "distress thermometer" (BTH; Mehnert et al., 2006)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-02551

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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