Trauma, Psychological; SomaticNCT05297435
Psychotraumatology in Somatic Medicine
An observational study of Trauma, Psychological; Somatic, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Trauma, Psychological; Somatic
- What is being tested?
- Questionnaires
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Jan 2021to 31 Dec 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Female patients of the preventive consultation of the gynecological clinic of the cantonal hospital St.Gallen
Who may be able to join
- At least 18 years old
- Female patients of the preventive consultation of the gynecological clinic of the cantonal hospital St.Gallen
Who cannot join
- Severe mental disorder (e.g. dissociative disorder)
- Insufficient knowledge of German
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Trauma, Psychological; Somatic
- Being tested
- Questionnaires
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesDiagnostic test
Questionnaire study
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of physician-patient relationship
German version of the questionnaire "Patient Reactions Assessment Instruments" (PRA-D; Brenk-Franz et al., 2016)
Measured: Day 0
Secondary outcomes (5)
Early traumatization
German version of the questionnaire "Childhood Trauma Questionnaire" (CTQ, Bernstein und Fink, 1998)
Measured: Day 0
Current traumatization
German version of the questionnaire "Impact of Event Scale-Revised" (IES-R; Weiss \& Marmar, 1997)
Measured: Day 0
Anxiety & Depression
German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; Herrmann et al., 1995; Hermann-Lingen et al., 2011)
Measured: Day 0
Dissociative symptoms
German questionnaire on dissociative symptoms (FDS-20; Spitzer et al., 2021)
Measured: Day 0
General distress
German version of the questionnaire "distress thermometer" (BTH; Mehnert et al., 2006)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start19 Jan 2021
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, Psychological; SomaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Haemmerli Keller, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297435
- Sponsor's protocol ID
- 2020-02551
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotraumatology in Somatic Medicine - Gynecological Consultation
- ClinicalTrials.gov ID
- NCT05297435
- Acronym / sponsor ID
- 2020-02551
- Conditions
- Trauma, Psychological; Somatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Female patients of the preventive consultation of the gynecological clinic of the cantonal hospital St.Gallen
Key inclusion criteria (2 listed)
- At least 18 years old
- Female patients of the preventive consultation of the gynecological clinic of the cantonal hospital St.Gallen
Key exclusion criteria (2 listed)
- Severe mental disorder (e.g. dissociative disorder)
- Insufficient knowledge of German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaire study | Diagnostic test | – |
Primary outcome
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)
5 secondary outcomes
Early traumatization
Time frame: Day 0
Current traumatization
Time frame: Day 0
Anxiety & Depression
Time frame: Day 0
Dissociative symptoms
Time frame: Day 0
General distress
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: No
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, Psychological; Somatic, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of physician-patient relationship (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.