Patient SatisfactionNCT04863599
Patient Experience With OMS Procedures Regarding Anesthesia
A study testing Questionnaire in people with Patient Satisfaction, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Jun 2021to 21 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- OMS procedure
- signed informed consent
- Age above 12 years
Who cannot join
- need for post-operative hospitalization
- mental disorder with no capability of filling in questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Patient Satisfaction
- Being tested
- Questionnaire
- Keywords
- General anesthesia, Sedation
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Patients will be asked to complete the Bauer and Brice questionnaire at post-operative day 1.
| Study group | Role | What they receive |
|---|---|---|
| OMS procedure under general anesthesia or sedation | Other | Questionnaire Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: post-operative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start24 Jun 2021
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dieter Mesotten, Ziekenhuis Oost-Limburg
- Investigators
- Joris Vundelinckx, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863599
- Sponsor's protocol ID
- Z-2021038
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Experience With OMS Procedures Under General Anesthesia Compared to Sedation
- ClinicalTrials.gov ID
- NCT04863599
- Acronym / sponsor ID
- Z-2021038
- Conditions
- Patient Satisfaction
- Keywords
- General anesthesia, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OMS procedure under general anesthesia or sedation | Other | Other: QuestionnaireQuestionnaire |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- OMS procedure
- signed informed consent
- Age above 12 years
Key exclusion criteria (2 listed)
- need for post-operative hospitalization
- mental disorder with no capability of filling in questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePatients will be asked to complete the Bauer and Brice questionnaire at post-operative day 1. | Other | OMS procedure under general anesthesia or sedation |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joris Vundelinckx principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Patient Satisfaction, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bauer questionnaire at post-operative day 1 (time frame: post-operative day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.