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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • Ordu, Turkey, 52200
        • Ordu University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
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.
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)
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.
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)
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.
one week before the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
1st, 3rd and 7th day after surgery
Analgesic consumption per day
Time Frame: 1st, 3rd and 7th day after surgery
Amount of analgesic consumption. High consumption show worse recovery
1st, 3rd and 7th day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
T.C. ORDU ÜNİVERSİTESİ

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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