Clinical trial NCT05548790: 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
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Third Molar Tooth
Dental Anxiety
Keywords: third molar extraction
Dental anxiety
preoperative information
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively
timeFrame: 2 minutes
measure: Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
timeFrame: 2 minutes
measure: Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
timeFrame: 1 minute
measure: Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım beyazıt University, Faculty of Dentistry
Study officials:
affiliation: Ankara Yıldırım Beyazıt University Faculty of Dentistry
name: kevser sancak
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.