NCT05297435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

March 11, 2022

Last Update Submit

March 25, 2022

Conditions

Trauma, Psychological; Somatic

Outcome Measures

Primary Outcomes (1)

  • Quality of physician-patient relationship

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

    Day 0

Secondary Outcomes (5)

  • Early traumatization

    Day 0

  • Current traumatization

    Day 0

  • Anxiety & Depression

    Day 0

  • Dissociative symptoms

    Day 0

  • General distress

    Day 0

Interventions

QuestionnairesDIAGNOSTIC_TEST

Questionnaire study

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • At least 18 years old
  • Female patients of the preventive consultation of the gynecological clinic of the cantonal hospital St.Gallen

You may not qualify if:

  • Severe mental disorder (e.g. dissociative disorder)
  • Insufficient knowledge of German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katja Haemmerli Keller

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. phil.

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 28, 2022

Study Start

January 19, 2021

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

March 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)