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Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties

Primary Purpose

Scales, Repression-Sensitization, Anesthesia Awareness

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Perioperative Satisfaction Scale in Regional Anesthesia
Sponsored by
Ömer Faruk Boran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Scales, Repression-Sensitization focused on measuring scale, validity, reliability

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kahramanmaras Sutcu Imam UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Psycometric analyses

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2019
Last Updated
February 19, 2020
Sponsor
Ömer Faruk Boran
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1. Study Identification

Unique Protocol Identification Number
NCT04009018
Brief Title
Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties
Official Title
Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ömer Faruk Boran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scales, Repression-Sensitization, Anesthesia Awareness
Keywords
scale, validity, reliability

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psycometric analyses
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Perioperative Satisfaction Scale in Regional Anesthesia
Other Intervention Name(s)
Measurement tool (Questionnaire)
Intervention Description
This study is methodological research. Perioperative Satisfaction Scale in Regional Anesthesia will be used to collect data.
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
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.
Time Frame
postoperative 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omer Faruk Boran, MD
Phone
05052855844
Email
ofboran@ksu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih Mehmet Yazar, MD
Organizational Affiliation
Kahramanmaras Sutcu Imam University
Official's Role
Study Chair
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University
City
Kahramanmaraş
ZIP/Postal Code
46100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omer Faruk Boran, MD
Phone
05052855844
Email
ofboran@ksu.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21455058
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.
Results Reference
background
PubMed Identifier
23221859
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/23221859
Description
Original validation study of Perioperative Satisfaction Scale in Regional Anesthesia

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Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties

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