- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528524
Validation of the German Quality of Recovery-15 Questionnaire
June 29, 2021 updated by: Marlene Fischer
Quality of Recovery After General Anesthesia for Elective Non-cardiac Surgery - Validation of the German Translation of the Quality of Recovery-15 Questionnaire
The Quality of Recovery 15-questionnaire (QoR-15) is used to assess postoperative quality of recovery after surgery and anesthesia from the patient's perspective.
It evaluates five dimensions including pain, physical comfort, physical independence, psychological support, and emotional state.
The aim of this study is to validate a German version of the QoR-15 scale (QoR-15Dt) to measure postoperative recovery in German-speaking patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
186
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
-
-
-
Hamburg, Germany, 20246
- Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
-
-
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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for elective non-cardiac surgery under general anesthesia in a tertiary care hospital.
Description
Inclusion Criteria:
- elective non-cardiac surgery
- fluency in German
- general anesthesia
Exclusion Criteria:
- postoperative intensive care unit admission
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the German version of the QoR-15 questionnaire
Time Frame: first postoperative day
|
Validity
|
first postoperative day
|
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)
August 17, 2020
Primary Completion (Actual)
April 17, 2021
Study Completion (Actual)
April 17, 2021
Study Registration Dates
First Submitted
August 24, 2020
First Submitted That Met QC Criteria
August 26, 2020
First Posted (Actual)
August 27, 2020
Study Record Updates
Last Update Posted (Actual)
June 30, 2021
Last Update Submitted That Met QC Criteria
June 29, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- PACQoR1
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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