Should Preoperative Information Before Impacted Third Molar Extraction?

September 17, 2022 updated by: Kevser SANCAK, Ankara Yildirim Beyazıt University

Should Preoperative Information Before Impacted Third Molar Extraction Be Visual, Verbal or Both?

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.

Study Overview

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

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06790
        • Ankara Yıldırım beyazıt University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 17, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 17, 2022

Last Verified

September 1, 2022

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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