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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04009018
Other study ID # Regional-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 20, 2019
Est. completion date March 1, 2020

Study information

Verified date February 2020
Source Kahramanmaras Sutcu Imam University
Contact Omer Faruk Boran, MD
Phone 05052855844
Email ofboran@ksu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 380
Est. completion date March 1, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Perioperative Satisfaction Scale in Regional Anesthesia
This study is methodological research. Perioperative Satisfaction Scale in Regional Anesthesia will be used to collect data.

Locations

Country Name City State
Turkey Kahramanmaras Sutcu Imam University Kahramanmaras

Sponsors (1)

Lead Sponsor Collaborator
Ömer Faruk Boran

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Patient satisfaction 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. postoperative 48 hours
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