Should Preoperative Information Before Impacted Third Molar Extraction?

Sponsor
Ankara Yildirim Beyazıt University (Other)
Overall Status
Completed
CT.gov ID
NCT05548790
Collaborator
(none)
86
1
4
2
43.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Spielberger State Anxiety Inventory (STAI-S)
  • Behavioral: Dental Fear Scale (DFS)
  • Behavioral: Modified Dental Anxiety Scale (MDAS)
  • Behavioral: Visual Analog Scale (VAS)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Should Preoperative Information Before Impacted Third Molar Extraction Be Visual, Verbal or Both?
Actual Study Start Date :
May 1, 2022
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

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

Behavioral: Spielberger State Anxiety Inventory (STAI-S)
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety

Behavioral: Dental Fear Scale (DFS)
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

Behavioral: Modified Dental Anxiety Scale (MDAS)
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

Behavioral: Visual Analog Scale (VAS)
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

Experimental: Group 2

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

Behavioral: Spielberger State Anxiety Inventory (STAI-S)
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety

Behavioral: Dental Fear Scale (DFS)
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

Behavioral: Modified Dental Anxiety Scale (MDAS)
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

Behavioral: Visual Analog Scale (VAS)
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

Experimental: Group 3

Group 3: patients were given written information brochure

Behavioral: Spielberger State Anxiety Inventory (STAI-S)
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety

Behavioral: Dental Fear Scale (DFS)
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

Behavioral: Modified Dental Anxiety Scale (MDAS)
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

Behavioral: Visual Analog Scale (VAS)
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

Experimental: Group 4

Group 4: patients were given information verbally

Behavioral: Spielberger State Anxiety Inventory (STAI-S)
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety

Behavioral: Dental Fear Scale (DFS)
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

Behavioral: Modified Dental Anxiety Scale (MDAS)
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

Behavioral: Visual Analog Scale (VAS)
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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively [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. Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively [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

  3. Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively [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

  4. Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Yıldırım beyazıt University, Faculty of Dentistry Ankara Turkey 06790

Sponsors and Collaborators

  • Ankara Yildirim Beyazıt University

Investigators

  • Principal Investigator: kevser sancak, Ankara Yıldırım Beyazıt University Faculty of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kevser SANCAK, oral and maxillofacial surgery, principal investigator, Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier:
NCT05548790
Other Study ID Numbers:
  • E-2022-14
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 21, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kevser SANCAK, oral and maxillofacial surgery, principal investigator, Ankara Yildirim Beyazıt University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2022