Should Preoperative Information Before Impacted Third Molar Extraction?

NCT05548790 | Completed

• 1 other identifier: E-2022-14
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Impacted Third Molar Tooth; Dental Anxiety

Keywords

third molar extraction; Dental anxiety; preoperative information

Outcome Measures

Primary Outcomes (4)

• 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

  2 minutes

• 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

  2 minutes

• 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

  1 minute

• 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

  1 minute

Study Arms (4)

Group 1

EXPERIMENTAL

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

Behavioral: Spielberger State Anxiety Inventory (STAI-S); Behavioral: Dental Fear Scale (DFS); Behavioral: Modified Dental Anxiety Scale (MDAS); Behavioral: Visual Analog Scale (VAS)

Group 2

EXPERIMENTAL

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

Behavioral: Spielberger State Anxiety Inventory (STAI-S); Behavioral: Dental Fear Scale (DFS); Behavioral: Modified Dental Anxiety Scale (MDAS); Behavioral: Visual Analog Scale (VAS)

Group 3

EXPERIMENTAL

Group 3: patients were given written information brochure

Behavioral: Spielberger State Anxiety Inventory (STAI-S); Behavioral: Dental Fear Scale (DFS); Behavioral: Modified Dental Anxiety Scale (MDAS); Behavioral: Visual Analog Scale (VAS)

Group 4

EXPERIMENTAL

Group 4: patients were given information verbally

Behavioral: Spielberger State Anxiety Inventory (STAI-S); Behavioral: Dental Fear Scale (DFS); Behavioral: Modified Dental Anxiety Scale (MDAS); Behavioral: Visual Analog Scale (VAS)

Interventions

Spielberger State Anxiety Inventory (STAI-S) BEHAVIORAL

STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety

Group 1; Group 2; Group 3; Group 4

Dental Fear Scale (DFS) BEHAVIORAL

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

Group 1; Group 2; Group 3; Group 4

Modified Dental Anxiety Scale (MDAS) BEHAVIORAL

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

Group 1; Group 2; Group 3; Group 4

Visual Analog Scale (VAS) BEHAVIORAL

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

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım beyazıt University, Faculty of Dentistry

Ankara, 06790, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 18423273 BACKGROUND

• 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.

  PMID: 30193118 BACKGROUND

• 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.

  PMID: 22832662 BACKGROUND

• 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.

  PMID: 18954863 BACKGROUND

Study Officials

• kevser sancak

  Ankara Yıldırım Beyazıt University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: oral and maxillofacial surgery, principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 21, 2022
• Study Start: May 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

TU (1)