Evaluation on the Anxiety of Third Molar Extraction

February 13, 2019 updated by: Kevser Sancak, Ankara University

Evaluation the Effect of Verbal & Written Information and the Previous Surgical Experience on the Anxiety of Third Molar Extraction

This study was performed on 66 patients who were admitted for third molar extraction under local anesthesia. The patients were divided into three groups: group 1 with verbal information, group 2 with written information, and group 3 with previous surgical experience. Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental Anxiety Scale (MDAS), and Visual Analog Scale (VAS) were used pre- and postoperatively to evaluate dental anxiety

Study Overview

Detailed Description

This prospective study included 66 patients who underwent third molar extraction under local anesthesia in the Oral and Maxillofacial Department, Faculty of Dentistry, Ankara University, Turkey, between September and November 2018. The research protocol was approved by the ethical committee of the institute (No: 36290600/69), Ankara University, Turkey.

Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental Anxiety Scale (MDAS), and Visual Analog Scale (VAS) are commonly used questionnaires for dental anxiety. The latter asked only about age and sex. They were used together before and immediately after surgery to obtain better results in this study.

After examining the panoramic radiographs, patients who underwent extraction were included in Classes 1 and II, Positions A and B according to Pell-Gregory 16 classification, and mesioangular and vertical positions according to the Winter 17 classification.

Each patient was examined by the researcher. The patients were informed about the procedure, and written informed consent was obtained from the patient's preoperative assessment clinic. If a patient had additional questions, they were included as part of the investigation.

The patients were divided into three groups:

Group 1: Patients who were given only basic information verbally Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods Group 3: Patients with previous experience and knowledge about third molar extraction Previous experience was determined before giving the questionnaires. The patients were randomly assigned to group 1 or 2 using an online random allocation software (www.randomization.com). Information was provided on how to complete questionnaires. STAI-S, MDAS, DFS, and VAS were applied to all patients 15 min before the surgery in the waiting room. The demographic data section (age and sex) in the form was filled out by the researcher.

The surgery was carried out under local anesthesia, with no pharmaceutical premedication or sedation. The surgical procedures were performed by a single experienced surgeon in the oral surgery clinic. After the surgery was completed, the patients were taken to the waiting room, and prescribed medications were given. STAI-S, MDAS, DFS, and VAS were reapplied after the surgery.

Study Type

Interventional

Enrollment (Actual)

66

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

      • Ankara, Turkey, 06500
        • Ankara University dentisry of faculty

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18-80 years
  • American Society of Anesthesiologists physical status score I and II
  • Patients without any systemic disease, or regular medication use.

Exclusion Criteria:

  • İnability to read and understand Turkish
  • Significantly impaired eyesight or hearing, an existing psychiatric disorder
  • Patients aged less than 18 years

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Group 1: Patients who were given only basic information verbally
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice
MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25
VAS is ideal for evaluating situations that cannot be measured using digital and oral information. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as "no anxiety" and the other end as "maximum anxiety imaginable
Experimental: Group 2
Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice
MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25
VAS is ideal for evaluating situations that cannot be measured using digital and oral information. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as "no anxiety" and the other end as "maximum anxiety imaginable
Experimental: Group 3
Group 3: Patients with previous experience and knowledge about third molar extraction
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice
MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25
VAS is ideal for evaluating situations that cannot be measured using digital and oral information. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as "no anxiety" and the other end as "maximum anxiety imaginable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively
Time Frame: 2 minutes
Spielberger State Anxiety Inventory (STAI) is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety. The inventory has 2 different scales, each with 20 items, showing the state and trait anxiety levels: STAI-state is used to determine a patient's current anxiety level, and STAI-trait is used to determine a patient's underlying (ongoing/personality) anxiety level. All 20 items are rated on a 4-point scale. The total score obtained can range from 20 to 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). We used only STAI-S
2 minutes
Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
Time Frame: 2 minutes
DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice
2 minutes
Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
Time Frame: 1 minute
MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25
1 minute
Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
Time Frame: 1 minute
VAS is ideal for evaluating situations that cannot be measured using digital and oral information 25. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as "no anxiety" and the other end as "maximum anxiety imaginable."
1 minute

Collaborators and Investigators

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

Investigators

  • Study Chair: Kevser Sancak, Ankara University Faculty of Dentısry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 15, 2018

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

January 5, 2019

Study Registration Dates

First Submitted

February 10, 2019

First Submitted That Met QC Criteria

February 10, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36290600/69

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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