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Completed

NCT Number: NCT05548790

Should Preoperative Information Before Impacted Third Molar Extraction?

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.

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Key information

Conditions

Impacted Third Molar Tooth Dental Anxiety

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Yıldırım beyazıt University, Faculty of Dentistry

Ankara, 06790, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

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

Primary outcomes

  1. 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. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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