The Influence of Sedation and General Anesthesia to Patients' Psycho-emotional State Undergoing Wisdom Teeth Extraction

Anxiety Clinical Trial

Official title:

The Influence of Sedation and General Anesthesia to Patients' Psycho-emotional State Undergoing Wisdom Teeth Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259463
• Other study ID #: BEC-OF-03
• Status: Completed
• Start date: October 21, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2022
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to evaluate, wheather the sedation or general anesthesia in third molar extractions influence the patient's psycho-emotional status. It is believed that the type of anesthesia may influence not only the psycho-emotional status after the procedure, but also before the procedure.

Description:

A prospective pilot study was conducted on adult patients who were admitted to the Faculty of Surgery at LSMU KK hospital for removal of all four wisdom teeth with sedation or general anesthesia. The patients were given one day to complete the given questionnaires. They were asked to complete three questionnaires: a) before the surgery, i.e. at the time the patient was hospitalized; b) the same day prior to surgery; c) ten days after the surgery. The operating doctor also filled out a questionnaire ten days after the surgery. The aim of the study is to evaluate, wheather the sedation or general anesthesia in third molar extractions influence the patient's psycho-emotional status. It is believed that the type of anesthesia may influence not only the psycho-emotional status after the procedure, but also before the procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient age = 18 years;
• Indicated removal of all 4 wisdom teeth;
• Non-use of NSAIDs, anticoagulants;
• No acute inflammation in the operated area;
• No history of common conditions that contraindicate oral surgery. For example, uncontrolled diabetes, cardiovascular disease;
• Patients agreed to participate in the study.

Exclusion Criteria:

• Pregnant, breastfeeding women;
• Individuals, formerly treated with radiation;
• Patients who participated in studies related to the assessment of psycho-emotional status;
• Patients with obvious mental, intellectual or physical disabilities limiting the participation in the study.

Related Conditions & MeSH terms

• Anxiety
• Fear
• Teeth, Impacted
• Tooth Loss
• Tooth, Impacted
• Tooth-loss

Intervention

Procedure:
• Third molars extraction
Third molars extractions with concious sedation or general anesthesia

Locations

Country	Name	City	State
Lithuania	Maxillofacial Surgery	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Inesa Astramskaite

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anesthesia effect on patients pre-operative psycho-emotional status: questionnaire	Anesthesia effect on patients pre-operative psycho-emotional status. The following scales are used: Universal Scale in Oral Surgery for psycho-emotional rating (1-3 raiting with higher rating meaning more negative psycho-emotional status); Modified Corah's Dental Anxiety Questionnaire (1-5 scores with with higher rating meaning more negative psycho-emotional status); visual analogue scales on fear of tooth extraction and fear of general anesthesia (1-5 scores with higher rating meaning higher fear)	baseline, pre-intervention/procedure/surgery
Primary	Anesthesia effect on patients pre-operative psycho-emotional status: questionnaire	Anesthesia effect on patients pre-operative psycho-emotional status. The following scales are used: Universal Scale in Oral Surgery for psycho-emotional rating (1-3 raiting with higher rating meaning more negative psycho-emotional status); Modified Corah's Dental Anxiety Questionnaire (1-5 scores with with higher rating meaning more negative psycho-emotional status); visual analogue scales on fear of tooth extraction and fear of general anesthesia (1-5 scores with higher rating meaning higher fear)	immediately after the intervention/procedure/surgery
Primary	Anesthesia effect on patients post-operative psycho-emotional status: questionnaire	Anesthesia effect on patients post-operative psycho-emotional status. The following scales are used: Universal Scale in Oral Surgery for psycho-emotional rating (1-3 raiting with higher rating meaning more negative psycho-emotional status); Modified Corah's Dental Anxiety Questionnaire (1-5 scores with with higher rating meaning more negative psycho-emotional status); visual analogue scales on fear of tooth extraction and fear of general anesthesia (1-5 scores with higher rating meaning higher fear). Also the pain that was felt immediately after the procedure, 6 hours after the procedure, 24 hours after the procedure, 2-10 days after the procedure was evaluated. The linear scale of 10cm was used, where the less points ment lower pain. Patient had to point the vertical dash on a line to represent the pain	10 days after after the intervention/procedure/surgery