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Should Preoperative Information Before Impacted Third Molar Extraction?

Primary Purpose

Impacted Third Molar Tooth, 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 Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring third molar extraction, Dental anxiety, preoperative information

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who did not have pain
  • Signs of infection related to the third molar were included
  • American Society of Anesthesiologists physical status score I and II
  • The absence of any systemic disease and regular medication use

Exclusion Criteria:

  • Patients have the presence of an existing psychiatric disorder, psychiatric disorders, anxiolytic or antidepressant drug treatment
  • Patients who were pregnant or lactated
  • Patients who couldn't understand or fill out questionnaires, had presence of visual or auditory deficits, refuse to watch the video or join the study, had incomplete data
  • Patients who had a previous negative experience with dental treatment were excluded from the study, as it may cause higher anxiety levels
  • Those who watched a video on the subject before were not included in the study

Sites / Locations

  • Ankara Yıldırım beyazıt University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Group 1: patients were given information via silent video with subtitle (5-minute)

Group 2: patients were given information via video with background audio (5-minute 34-second)

Group 3: patients were given written information brochure

Group 4: patients were given information verbally

Outcomes

Primary Outcome Measures

Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively
STAI-S is a 20-item scale that determines the current anxiety level of the patient with reliability and validity in Turkish. Widely used to assess anxiety, the STAI explores the transient state of anxiety, and patients report how they are feeling at the current time point. It is scored using a 4-level frequency scale ranging from 0 to 3. The total score ranges from 20 to 80, higher scores indicates higher anxiety
Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
DFS is which consists of 20-items is used to determine physiological responses to dental stimuli via a Likert-type scale ranging from 1 to 5. Total scores change from 20 to 100 point. It collects the evaluation of dental anxiety under 3 headings. The first 2 questions assess avoidance of dentistry, questions 3-7 show physiological arousal, and questions 8-20 predict fear of certain situations
Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
MDAS which is created by adding one question to the Corah Dental Anxiety Scale have 5-item questionnaire with 5-point Likert-type scale. Scale shows points between 5 and 25
Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
VAS is a digital and verbal assessment scale used to measure anxiety. A closed-ended scale of 0-100 mm ("0" no anxiety, "100" maximum imaginable anxiety) was used in the study, and participants were asked to put a mark on the VAS scale, which they thought showed the degree of their current anxiety

Secondary Outcome Measures

Full Information

First Posted
September 9, 2022
Last Updated
September 17, 2022
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT05548790
Brief Title
Should Preoperative Information Before Impacted Third Molar Extraction?
Official Title
Should Preoperative Information Before Impacted Third Molar Extraction Be Visual, Verbal or Both?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The main objective of the present study was to evaluate the effects of different preoperative information techniques (verbal, written, video with background audio, and silent video with subtitles) on patients' anxiety levels before and after third molar extraction. The secondary objective was to determine the superiority of the information methods evaluated over each other. We hypothesized that the information provided by video with or without background audio would decrease preoperative and postoperative anxiety levels more effectively than information provided by verbal and written methods.
Detailed Description
This prospective study included 86 patients who underwent third molar extraction under local anesthesia in the Oral and Maxillofacial Department, Faculty of Dentistry, Ankara Yıldırım Beyazıt University, Turkey, between May and June 2022. The research protocol was approved by The Yıldırım Beyazıt University Oral and Health Training and Research Hospital Ethical Committee,Turkey. (No: E-2022-14) 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 classification, and mesioangular and vertical positions according to the Winter 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 Patients were assigned to 4 groups: Group 1 was informed via silent video with subtitle, group 2 was informed via video with background audio, group 3 was informed with written information brochure, group 4 (control group) was informed preoperatively verbally. The 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 the dental anxiety of patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth, Dental Anxiety
Keywords
third molar extraction, Dental anxiety, preoperative information

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1 was informed via silent video with subtitle, group 2 was informed via video with background audio, group 3 was informed with written information brochure, group 4 (control group) was informed verbally.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1: patients were given information via silent video with subtitle (5-minute)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Group 2: patients were given information via video with background audio (5-minute 34-second)
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Group 3: patients were given written information brochure
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Group 4: patients were given information verbally
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
STAI-S is a 20-item scale that determines the current anxiety level of the patient with reliability and validity in Turkish. Widely used to assess anxiety, the STAI explores the transient state of anxiety, and patients report how they are feeling at the current time point. It is scored using a 4-level frequency scale ranging from 0 to 3. The total score ranges from 20 to 80, higher scores indicates higher anxiety
Time Frame
2 minutes
Title
Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
Description
DFS is which consists of 20-items is used to determine physiological responses to dental stimuli via a Likert-type scale ranging from 1 to 5. Total scores change from 20 to 100 point. It collects the evaluation of dental anxiety under 3 headings. The first 2 questions assess avoidance of dentistry, questions 3-7 show physiological arousal, and questions 8-20 predict fear of certain situations
Time Frame
2 minutes
Title
Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
Description
MDAS which is created by adding one question to the Corah Dental Anxiety Scale have 5-item questionnaire with 5-point Likert-type scale. Scale shows points 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 a digital and verbal assessment scale used to measure anxiety. A closed-ended scale of 0-100 mm ("0" no anxiety, "100" maximum imaginable anxiety) was used in the study, and participants were asked to put a mark on the VAS scale, which they thought showed the degree of their current anxiety
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: Patients who did not have pain Signs of infection related to the third molar were included American Society of Anesthesiologists physical status score I and II The absence of any systemic disease and regular medication use Exclusion Criteria: Patients have the presence of an existing psychiatric disorder, psychiatric disorders, anxiolytic or antidepressant drug treatment Patients who were pregnant or lactated Patients who couldn't understand or fill out questionnaires, had presence of visual or auditory deficits, refuse to watch the video or join the study, had incomplete data Patients who had a previous negative experience with dental treatment were excluded from the study, as it may cause higher anxiety levels Those who watched a video on the subject before were not included in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kevser sancak
Organizational Affiliation
Ankara Yıldırım Beyazıt University Faculty of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yıldırım beyazıt University, Faculty of Dentistry
City
Ankara
ZIP/Postal Code
06790
Country
Turkey

12. IPD Sharing Statement

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
30193118
Citation
Laskin DM, Priest JH, Alfaqih S, Carrico CK. Does Viewing a Third Molar Informed Consent Video Decrease Patients' Anxiety? J Oral Maxillofac Surg. 2018 Dec;76(12):2515-2517. doi: 10.1016/j.joms.2018.08.001. Epub 2018 Aug 15.
Results Reference
background
PubMed Identifier
22832662
Citation
Sirin Y, Humphris G, Sencan S, Firat D. What is the most fearful intervention in ambulatory oral surgery? Analysis of an outpatient clinic. Int J Oral Maxillofac Surg. 2012 Oct;41(10):1284-90. doi: 10.1016/j.ijom.2012.06.013. Epub 2012 Jul 23.
Results Reference
background
PubMed Identifier
18954863
Citation
de Jongh A, Olff M, van Hoolwerff H, Aartman IH, Broekman B, Lindauer R, Boer F. Anxiety and post-traumatic stress symptoms following wisdom tooth removal. Behav Res Ther. 2008 Dec;46(12):1305-10. doi: 10.1016/j.brat.2008.09.004. Epub 2008 Sep 25.
Results Reference
background

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Should Preoperative Information Before Impacted Third Molar Extraction?

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