NCT04863599

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 24, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2021

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

April 26, 2021

Last Update Submit

April 12, 2023

Conditions

Patient Satisfaction

Keywords

General anesthesiaSedation

Outcome Measures

Primary Outcomes (2)

  • Bauer questionnaire at 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

    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

Study Arms (1)

OMS procedure under general anesthesia or sedation

OTHER

Questionnaire

Other: Questionnaire

Interventions

QuestionnaireOTHER

Patients will be asked to complete the Bauer and Brice questionnaire at post-operative day 1.

OMS procedure under general anesthesia or sedation

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Joris Vundelinckx

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 28, 2021

Study Start

June 24, 2021

Primary Completion

September 21, 2021

Study Completion

September 21, 2021

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)