- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05297435
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
Conditions
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.
Sponsor
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Trauma, Psychological; Somatic
-
Daniel MarotiWayne State UniversityActive, not recruitingSomatic Symptom Disorder | Functional Somatic DisorderSweden
-
Region StockholmKarolinska InstitutetActive, not recruitingMedically Unexplained Symptoms | Somatic Symptom and Related Disorders | Psychological Factors Affecting Other Medical ConditionsSweden
-
Daniel MarotiWayne State UniversityRecruitingSomatic Symptom Disorder | Functional Somatic Disorder | Functional Somatic SyndromesSweden
-
Victor CarrionUniversity of South Carolina; Iowa State University; University of San Diego; Pure...CompletedStress, Psychological | Trauma, Psychological
-
A.T. Still University of Health SciencesCompletedSomatic Dysfunction of Cranial Region | Somatic Dysfunction of Cervical Spine | Somatic Dysfunction of Lumbar Spine | Somatic Dysfunction of SacrumUnited States
-
Hôpital le VinatierNot yet recruitingTrauma, Psychological
-
Dominique JANUELRecruiting
-
University of OtagoRecruitingTrauma, Psychological | EarthquakeNew Zealand
-
Nottingham Trent UniversityNot yet recruitingTrauma, Psychological | Legal Education
-
Trauma Institute & Child Trauma InstituteGratis FoundationUnknownTrauma, Psychological | Conflict, InterparentalUnited States
Clinical Trials on Questionnaires
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Direction Centrale du Service de Santé des ArméesCompleted
-
Sun Yat-sen UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingIntensive Care Unit Syndrome | Pediatric Post-intensive Care SyndromeFrance
-
University Hospital, GrenobleUniversity Grenoble AlpsNot yet recruitingChildhood Cancer | Adapted Physical ActivityFrance
-
M.D. Anderson Cancer CenterCompletedAdvanced Cancer | Malignant Neoplasms of Independent (Primary) Multiple SitesUnited States
-
The University of Hong KongCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Cliniques universitaires Saint-Luc- Université...Fonds National de la Recherche ScientifiqueNot yet recruitingAlcohol Use Disorder
-
Memorial Sloan Kettering Cancer CenterIcahn School of Medicine at Mount Sinai; Hackensack Meridian Health; Derald H...CompletedLeukemia | Multiple Myeloma | Non-Hodgkin's Lymphoma | Hodgkin's DiseaseUnited States