Does Watching Video Increase the Perioperative Anxiety in Patients Undergoing Third Molar Surgery

NCT03889691 | Completed

• 1 other identifier: 2018-182
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

Third molar extraction is the most common surgical procedure in the field of oral and maxillofacial surgery and usually cause anxiety. Although different informed consent methods have been used previously, the most effective information method that provide the optimum anxiety management is still not clear. Therefore, investigators planned a clinical study to explore the effect of different information formats (verbal information with written document and verbal information with written document subsequent to watching video from internet) on peri-operative anxiety of the participants who scheduled to undergo impacted lower third molar surgery. Also, investigators aimed to explore the effect internet usage before the third molar surgery on the level of anxiety.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (4)

• Anxiety change being assessed with Spielberger State Anxiety Inventory (STAI-S)

  There are total 40 questions in STAI-S (20). For each question the patients score ranged from 1 (almost never) to 4 (almost always) points. The sum of the scores range from 20-80. The score between 36 to 41 refer the mean anxiety level, and the values above 41 classified as high level of anxiety.

  one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure

• Anxiety change being assessed with Modified Dental Anxiety Scale (MDAS)

  MDAS consists of five questions in total which measures anxiety at different stages of dental treatment. 1 (no anxious) to 5 (very anxious) options are available for each question. The sum of the scores varies from 5 to 25 and the values between 19-25 indicates high dental anxiety.

  one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure

• Anxiety change being assessed with Amsterdam Preoperative Anxiety Inventory (APAIS)

  APAIS is a scale consisting of 6 items, 3 of them are related to anesthesia and the others related to surgical procedure. The scoring ranges from 6 to 30 in total. The value of \>11 is considered as high-anxiety level.

  one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure

• Trait Anxiety assessed with Spielberger Trait Anxiety Inventory (STAI-T)

  There are total 40 questions in d STAI-T (20). For each question the patients score ranged from 1 (almost never) to 4 (almost always) points. The sum of the scores range from 20-80. The score between 36 to 41 refer the mean anxiety level, and the values above 41 classified as high level of anxiety.

  one week before the procedure

Secondary Outcomes (2)

• Pain severity change

  1st, 3rd and 7th day after surgery

• Analgesic consumption per day

  1st, 3rd and 7th day after surgery

Study Arms (2)

Control group

The control group consisted of patients who verbal explanation of the surgical procedure and the potential postoperative complications was given with a written informed consent document

Procedure: Third molar surgery

Study group

Participants in the study group asked to watch impacted lower third molar extraction video which was previously uploaded to the internet with their own device. This video includes only visual components of the surgery such as anesthesia, incision, extraction and suturing. Patients in the second group were also informed verbally about the surgical procedure-possible postoperative complications and was given with a written informed consent document.

Procedure: Third molar surgery

Interventions

Third molar surgery PROCEDURE

Surgical extraction of impacted lower third molar tooth under local anesthesia

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients who scheduled to underwent impacted lower third molar removal in the Oral and Maxillofacial Surgery Clinic of Ordu University between August 2018 to February 2019.

You may qualify if:

• patients;
• without systemic disease,
• have indication for third molar extraction,
• radiographic degree of impaction according to the classification of Winter (vertical and mesio-angular) and the classification of Pell and Gregory 2, or 3 and B

You may not qualify if:

• patients who;
• has psychiatric illness and systemic disease,
• refused to watch the video,
• failed to fill out the forms for any reason,
• had incomplete data and wanted to withdraw from the study,
• had underwent a previous third molar surgery,
• had history of anxiety attacks and/or anxiolytic treatment,
• had unpleasant dental treatment experience could not cooperated,

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University

Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Mehmet M Omezli, PhD

  Associate Professor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 26, 2019
• Study Start: August 8, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 6 months after publication
• Access Criteria: Contributors of the study will review requests

Locations

TU (1)