An observational study in Anxiety, sponsored by T.C. ORDU ÜNİVERSİTESİ. Completed at 1 site in Turkey. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by T.C. ORDU ÜNİVERSİTESİ · Observational
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 113 is below the median of 150 across 606 observational studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →T.C. ORDU ÜNİVERSİTESİ is the lead sponsor of 87 studies on the registry; 12 are open to participants now.
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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.
patients;
Exclusion Criteria:
patients who;
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
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
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.
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
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.
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
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.
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
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.
Time frame: one week before the procedure
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).
Time frame: 1st, 3rd and 7th day after surgery
Analgesic consumption per day
Amount of analgesic consumption. High consumption show worse recovery
Time frame: 1st, 3rd and 7th day after surgery
Plan to share: Yes — all individual participant data that underlie results of the publication of the study
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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T.C. ORDU ÜNİVERSİTESİ