- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05548790
Should Preoperative Information Before Impacted Third Molar Extraction?
Should Preoperative Information Before Impacted Third Molar Extraction Be Visual, Verbal or Both?
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey, 06790
- Ankara Yıldırım beyazıt University, Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Group 1: patients were given information via silent video with subtitle (5-minute)
|
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
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
|
|
Experimental: Group 2
Group 2: patients were given information via video with background audio (5-minute 34-second)
|
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
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
|
|
Experimental: Group 3
Group 3: patients were given written information brochure
|
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
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
|
|
Experimental: Group 4
Group 4: patients were given information verbally
|
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
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
|
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
|
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
|
2 minutes
|
|
Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
Time Frame: 2 minutes
|
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
|
2 minutes
|
|
Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
Time Frame: 1 minute
|
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
|
1 minute
|
|
Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
Time Frame: 1 minute
|
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
|
1 minute
|
Collaborators and Investigators
Investigators
- Principal Investigator: kevser sancak, Ankara Yıldırım Beyazıt University Faculty of Dentistry
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-2022-14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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