Patient Experience With OMS Procedures Regarding Anesthesia

Sponsor

Ziekenhuis Oost-Limburg (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04863599

Collaborator

(none)

120

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction	Other: Questionnaire	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Patient Experience With OMS Procedures Under General Anesthesia Compared to Sedation

Anticipated Study Start Date :

May 30, 2021

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Bauer questionnaire at post-operative day 1 [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.
Brice questionnaire at post-operative day 1 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ziekenhuis Oost-Limburg

Investigators

Principal Investigator: Joris Vundelinckx, Ziekenhuis Oost-Limburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ziekenhuis Oost-Limburg

ClinicalTrials.gov Identifier:

NCT04863599

Other Study ID Numbers:

Z-2021038

First Posted:

Apr 28, 2021

Last Update Posted:

Apr 28, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ziekenhuis Oost-Limburg

General anesthesia

Sedation

Study Results

No Results Posted as of Apr 28, 2021