NCT04009018

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

June 26, 2019

Last Update Submit

February 19, 2020

Conditions

Scales, Repression-SensitizationAnesthesia Awareness

Keywords

scalevalidityreliability

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Psycometric analyses

OTHER

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.

Other: Perioperative Satisfaction Scale in Regional Anesthesia

Interventions

Perioperative Satisfaction Scale in Regional AnesthesiaOTHER

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

Also known as: Measurement tool (Questionnaire)
Psycometric analyses

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Lack of Turkish literacy
  • Use of anesthesia technique other than regional anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, 46100, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 21455058BACKGROUND

  • 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.

    PMID: 23221859RESULT

Related Links

MeSH Terms

Conditions

Intraoperative Awareness

Interventions

Anesthesia, ConductionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Intraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Fatih Mehmet Yazar, MD

    Kahramanmaras Sutcu Imam University

    STUDY CHAIR

Central Study Contacts

Omer Faruk Boran, MD

CONTACT

05052855844ofboran@ksu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 5, 2019

Study Start

June 20, 2019

Primary Completion

February 20, 2020

Study Completion

March 1, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)