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

• ClinicalTrials.gov Identifier: NCT03889691
• Recruitment Status: Completed
• First Posted: March 26, 2019
• Last Update Posted: March 26, 2019
• Sponsor: T.C. ORDU ÜNİVERSİTESİ
• Information provided by (Responsible Party): Dr. Damla Torul, T.C. ORDU ÜNİVERSİTESİ

Study Description

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.

Condition or disease	Intervention/treatment
Anxiety	Procedure: Third molar surgery

Detailed Description:

The participants were randomly divided into two groups. The control group consisted of participants who informed verbally about the surgical procedure and the potential postoperative complications,. Also, a written informed consent document was given. Participants in the study group were asked to watch a video which was previously uploaded to the internet and was showed procedural details of an impacted right lower third molar extraction (with permission and written consent). Participants in the study group were also informed verbally about the surgical procedure-possible postoperative complications and was given with a written informed consent document. In both groups questions of the participants were answered by the same surgeon. To evaluate anxiety; participants were asked to complete 3 questionnaires 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 113 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Does Watching Video Increase the Perioperative Anxiety in Patients Undergoing Third Molar Surgery
• Actual Study Start Date: August 8, 2018
• Actual Primary Completion Date: March 1, 2019
• Actual Study Completion Date: March 1, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; Surgical extraction of impacted lower third molar tooth under local anesthesia
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; Surgical extraction of impacted lower third molar tooth under local anesthesia

Outcome Measures

Primary Outcome Measures :

1. Anxiety change being assessed with Spielberger State Anxiety Inventory (STAI-S) [ Time Frame: 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 ]
   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.
2. Anxiety change being assessed with Modified Dental Anxiety Scale (MDAS) [ Time Frame: 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 ]
   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.
3. Anxiety change being assessed with Amsterdam Preoperative Anxiety Inventory (APAIS) [ Time Frame: 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 ]
   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.
4. Trait Anxiety assessed with Spielberger Trait Anxiety Inventory (STAI-T) [ Time Frame: one week before the procedure ]
   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.

Secondary Outcome Measures :

1. Pain severity change [ Time Frame: 1st, 3rd and 7th day after surgery ]
   Pain measured with Visual Analog scale (VAS) The pain levels of the patients were evaluated by a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (extremely pain).
2. Analgesic consumption per day [ Time Frame: 1st, 3rd and 7th day after surgery ]
   Amount of analgesic consumption. High consumption show worse recovery

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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,

Contacts and Locations

Locations

Turkey

Ordu University

Ordu, Turkey, 52200

Sponsors and Collaborators

T.C. ORDU ÜNİVERSİTESİ

Investigators

• Study Director: Mehmet M Omezli, PhD; Associate Professor

More Information

• Responsible Party: Dr. Damla Torul, Research Asistant, T.C. ORDU ÜNİVERSİTESİ
• ClinicalTrials.gov Identifier: NCT03889691
• Other Study ID Numbers: 2018-182
• First Posted: March 26, 2019
• Last Update Posted: March 26, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: all individual participant data that underlie results of the publication of the study
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: starting 6 months after publication
• Access Criteria: Contributors of the study will review requests

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders