AnxietyNCT03889691
Does Watching Video Increase the Perioperative Anxiety in Patients Undergoing Third Molar Surgery
An observational study of Anxiety, run by Ordu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Third molar surgery
- Type of treatment
- Surgery or procedure
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2018to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Third molar surgery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third molar surgeryProcedure or surgery
Surgical extraction of impacted lower third molar tooth under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Third molar surgery | |
| 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. Receives: Procedure: Third molar surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one week before the procedure
Secondary outcomes (2)
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).
Measured: 1st, 3rd and 7th day after surgery
Analgesic consumption per day
Amount of analgesic consumption. High consumption show worse recovery
Measured: 1st, 3rd and 7th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start8 Aug 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Damla Torul, Ordu University
- Investigators
- Mehmet M Omezli, PhD, Study director, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889691
- Sponsor's protocol ID
- 2018-182
- Status last verified
- Mar 2019
- First submitted
- 21 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data that underlie results of the publication of the study
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Watching Video Increase the Perioperative Anxiety in Patients Undergoing Third Molar Surgery
- ClinicalTrials.gov ID
- NCT03889691
- Acronym / sponsor ID
- 2018-182
- Conditions
- Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Procedure: Third molar surgeryThe 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 |
| Study group | – | Procedure: Third molar surgeryParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Third molar surgerySurgical extraction of impacted lower third molar tooth under local anesthesia | Procedure or surgery | Control group, Study group |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Pain severity change
Time frame: 1st, 3rd and 7th day after surgery
Analgesic consumption per day
Time frame: 1st, 3rd and 7th day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: Yes. all individual participant data that underlie results of the publication of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet M Omezli, PhD study director
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.