- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04009018
Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties
February 19, 2020 updated by: Ömer Faruk Boran
The aim of the study is to determine the psychometric properties of Perioperative Satisfaction Scale in Regional Anesthesia.
In the Turkish version of the scale, a blind reverse translation method will use.
And validity and reliability analyses will conduct.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
The aim of the present research is to contribute to the international literature determining and describing the factor structure and psychometric qualities of the Perioperative Satisfaction Scale in Regional Anesthesia.
An additional aim is to contribute to the national literature regarding the performance of the instrument in cross-cultural adaptation.
The following steps will be taken: (a) translation of the scale from English into Turkish, (b) data collection, and (c) checking validity and reliability evidence for the adapted Perioperative Satisfaction Scale in Regional Anesthesia.
Study Type
Interventional
Enrollment (Anticipated)
380
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Omer Faruk Boran, MD
- Phone Number: 05052855844
- Email: ofboran@ksu.edu.tr
Study Locations
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-
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Kahramanmaraş, Turkey, 46100
- Recruiting
- Kahramanmaras Sutcu Imam University
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Contact:
- Omer Faruk Boran, MD
- Phone Number: 05052855844
- Email: ofboran@ksu.edu.tr
-
-
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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Volunteer to participate in the research
- Participants are over 18 years of age
- Provided regional anesthesia
- Postoperative second day
- No cognitive problems in self-expression
Exclusion Criteria:
- Lack of Turkish literacy
- Use of anesthesia technique other than regional anesthesia
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
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Psycometric analyses
It will be a validation study of the Perioperative Satisfaction Scale in Regional Anesthesia.
This study is not experimental research.
This is a psychometric assessment study of a questionnaire and data will collect pencil-paper survey and face to face from the patients who will get regional anesthesia in the postoperative second day.
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This study is methodological research.
Perioperative Satisfaction Scale in Regional Anesthesia will be used to collect data.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: postoperative 48 hours
|
Perioperative Satisfaction Scale in Regional Anesthesia will be applied, side effects such as nausea-vomiting, drowsiness will be noted.
Patient satisfaction will be assessed with these methods as bad, medium, good, and very good.
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postoperative 48 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Fatih Mehmet Yazar, MD, Kahramanmaras Sutcu Imam University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mui WC, Chang CM, Cheng KF, Lee TY, Ng KO, Tsao KR, Hwang FM. Development and validation of the questionnaire of satisfaction with perioperative anesthetic care for general and regional anesthesia in Taiwanese patients. Anesthesiology. 2011 May;114(5):1064-75. doi: 10.1097/ALN.0b013e318216e835.
- Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.
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)
June 20, 2019
Primary Completion (Actual)
February 20, 2020
Study Completion (Anticipated)
March 1, 2020
Study Registration Dates
First Submitted
June 26, 2019
First Submitted That Met QC Criteria
July 2, 2019
First Posted (Actual)
July 5, 2019
Study Record Updates
Last Update Posted (Actual)
February 20, 2020
Last Update Submitted That Met QC Criteria
February 19, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Regional-1
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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