Patient Experience With OMS Procedures Regarding Anesthesia

April 12, 2023 updated by: Dieter Mesotten, Ziekenhuis Oost-Limburg

Patient Experience With OMS Procedures Under General Anesthesia Compared to Sedation

The main purpose of the study is to know more about the experience/satisfaction of patients undergoing oral and maxillofacial surgery (OMS). Depending on the type of procedure, the patient will receive a sedation or a general anesthesia. At the first day post-operatively, patients will be contacted to complete a questionnaire. The questionnaire will be subdivided into anaesthesia-related discomfort and anaesthesia care in general.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

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 Locations

  • Belgium
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • OMS procedure
  • signed informed consent
  • Age above 12 years

Exclusion Criteria:

  • need for post-operative hospitalization
  • mental disorder with no capability of filling in questionnaires

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: OMS procedure under general anesthesia or sedation
Questionnaire
Other: Questionnaire
Patients will be asked to complete the Bauer and Brice questionnaire at post-operative day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bauer questionnaire at post-operative day 1
Time Frame: post-operative day 1
The Bauer questionnaire contains a set of questions on anaesthesia-related discomfort and another set on satisfaction with anaesthesia care in general. The questions on discomfort will be assessed on a 3-point scale, and those on patient satisfaction on a 4-point scale.
post-operative day 1
Brice questionnaire at post-operative day 1
Time Frame: post-operative day 1
The questionnaire attempts to identify patients who may have had memories of their operation i.e. accidental awareness under anesthesia. These are open questions.
post-operative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziekenhuis Oost-Limburg

Investigators

  • Principal Investigator: Joris Vundelinckx, Ziekenhuis Oost-Limburg

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 24, 2021

Primary Completion (Actual)

September 21, 2021

Study Completion (Actual)

September 21, 2021

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Z-2021038

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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