- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03889691
Does Watching Video Increase the Perioperative Anxiety in Patients Undergoing Third Molar Surgery
March 22, 2019 updated by: Dr. Damla Torul, T.C. ORDU ÜNİVERSİTESİ
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
113
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ordu, Turkey, 52200
- Ordu University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders 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.
Description
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,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
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
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Surgical extraction of impacted lower third molar tooth under local anesthesia
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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.
|
Surgical extraction of impacted lower third molar tooth under local anesthesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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Trait Anxiety assessed with Spielberger Trait Anxiety Inventory (STAI-T)
Time Frame: one week before the procedure
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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.
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one week before the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain severity change
Time Frame: 1st, 3rd and 7th day after surgery
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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).
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1st, 3rd and 7th day after surgery
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Analgesic consumption per day
Time Frame: 1st, 3rd and 7th day after surgery
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Amount of analgesic consumption.
High consumption show worse recovery
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1st, 3rd and 7th day after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mehmet M Omezli, PhD, Associate Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2018
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
March 21, 2019
First Submitted That Met QC Criteria
March 22, 2019
First Posted (Actual)
March 26, 2019
Study Record Updates
Last Update Posted (Actual)
March 26, 2019
Last Update Submitted That Met QC Criteria
March 22, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
all individual participant data that underlie results of the publication of the study
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
Contributors of the study will review requests
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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