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Evaluation on the Anxiety of Third Molar Extraction

Primary Purpose

Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spielberger State Anxiety Inventory (STAI-S),
Dental Fear Scale (DFS)
Modified Dental Anxiety Scale (MDAS)
Visual Analog Scale (VAS)
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dental Anxiety focused on measuring third molar extraction, Preoperative anxiety, Dental Anxiety

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ankara University dentisry of faculty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively
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
Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
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
Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
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
Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
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."

Secondary Outcome Measures

Full Information

First Posted
February 10, 2019
Last Updated
February 13, 2019
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT03838081
Brief Title
Evaluation on the Anxiety of Third Molar Extraction
Official Title
Evaluation the Effect of Verbal & Written Information and the Previous Surgical Experience on the Anxiety of Third Molar Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
January 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
Keywords
third molar extraction, Preoperative anxiety, Dental Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1: Patients who were given only basic information verbally
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Group 3: Patients with previous experience and knowledge about third molar extraction
Intervention Type
Behavioral
Intervention Name(s)
Spielberger State Anxiety Inventory (STAI-S),
Intervention Description
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
Intervention Type
Behavioral
Intervention Name(s)
Dental Fear Scale (DFS)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Modified Dental Anxiety Scale (MDAS)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Visual Analog Scale (VAS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively
Description
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
Time Frame
2 minutes
Title
Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
Description
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
Time Frame
2 minutes
Title
Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
Description
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
Time Frame
1 minute
Title
Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
Description
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."
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevser Sancak
Organizational Affiliation
Ankara University Faculty of Dentısry
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara University dentisry of faculty
City
Ankara
ZIP/Postal Code
06500
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18423273
Citation
Muglali M, Komerik N. Factors related to patients' anxiety before and after oral surgery. J Oral Maxillofac Surg. 2008 May;66(5):870-7. doi: 10.1016/j.joms.2007.06.662.
Results Reference
background
PubMed Identifier
19672334
Citation
Jaakkola S, Rautava P, Alanen P, Aromaa M, Pienihakkinen K, Raiha H, Vahlberg T, Mattila ML, Sillanpaa M. Dental fear: one single clinical question for measurement. Open Dent J. 2009 Jul 28;3:161-6. doi: 10.2174/1874210600903010161.
Results Reference
background
Citation
Pell GJ. Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933;39:330-338.
Results Reference
background
Citation
Winter GB. Principles of exodontia as applied to the impacted mandibular third molar. American Medical Book Company; 1926.
Results Reference
background
Citation
Ost L-g, Öst L-G, Skaret E. Cognitive behavioral therapy for dental phobia and anxiety. John Wiley & Sons; 2013
Results Reference
background

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Evaluation on the Anxiety of Third Molar Extraction

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