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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889691
• Other study ID #: 2018-182
• Status: Completed
• Start date: August 8, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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,

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Procedure:
• Third molar surgery
Surgical extraction of impacted lower third molar tooth under local anesthesia

Locations

Country	Name	City	State
Turkey	Ordu University	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Pain severity change	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).	1st, 3rd and 7th day after surgery
Secondary	Analgesic consumption per day	Amount of analgesic consumption. High consumption show worse recovery	1st, 3rd and 7th day after surgery