Clinical trial NCT03889691: Does Watching Video Increase the Perioperative Anxiety in Patients Undergoing Third Molar Surgery
Official title: Does Watching Video Increase the Perioperative Anxiety in Patients Undergoing Third Molar Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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,

Primary outcomes:
measure: Anxiety change being assessed with Spielberger State Anxiety Inventory (STAI-S)
timeFrame: 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
measure: Anxiety change being assessed with Modified Dental Anxiety Scale (MDAS)
timeFrame: 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
measure: Anxiety change being assessed with Amsterdam Preoperative Anxiety Inventory (APAIS)
timeFrame: 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
measure: Trait Anxiety assessed with Spielberger Trait Anxiety Inventory (STAI-T)
timeFrame: one week before the procedure
Secondary outcomes:
measure: Pain severity change
timeFrame: 1st, 3rd and 7th day after surgery
measure: Analgesic consumption per day
timeFrame: 1st, 3rd and 7th day after surgery
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
Study officials:
affiliation: Associate Professor
name: Mehmet M Omezli, PhD
role: STUDY_DIRECTOR
References: