Dental AnxietyNCT03838081
Evaluation on the Anxiety of Third Molar Extraction
A study testing Spielberger State Anxiety Inventory (STAI-S),, Dental Fear Scale (DFS) and Modified Dental Anxiety Scale (MDAS) in people with Dental Anxiety, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This study was performed on 66 patients who were admitted for third molar extraction under local anesthesia. The patients were divided into three groups: group 1 with verbal information, group 2 with written information, and group 3 with previous surgical experience. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Spielberger State Anxiety Inventory (STAI-S),, Dental Fear Scale (DFS) and Modified Dental Anxiety Scale (MDAS)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2018to 5 Jan 2019
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-80 years
- American Society of Anesthesiologists physical status score I and II
- Patients without any systemic disease, or regular medication use.
Who cannot join
- İnability to read and understand Turkish
- Significantly impaired eyesight or hearing, an existing psychiatric disorder
- Patients aged less than 18 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University dentisry of faculty
Ankara, 06500
About this study
Official title: Evaluation the Effect of Verbal & Written Information and the Previous Surgical Experience on the Anxiety of Third Molar Extraction
This study was performed on 66 patients who were admitted for third molar extraction under local anesthesia. The patients were divided into three groups: group 1 with verbal information, group 2 with written information, and group 3 with previous surgical experience. Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental Anxiety Scale (MDAS), and Visual Analog Scale (VAS) were used pre- and postoperatively to evaluate dental anxiety
Read the detailed description
This prospective study included 66 patients who underwent third molar extraction under local anesthesia in the Oral and Maxillofacial Department, Faculty of Dentistry, Ankara University, Turkey, between September and November 2018. The research protocol was approved by the ethical committee of the institute (No: 36290600/69), Ankara University, Turkey.
Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental Anxiety Scale (MDAS), and Visual Analog Scale (VAS) are commonly used questionnaires for dental anxiety. The latter asked only about age and sex. They were used together before and immediately after surgery to obtain better results in this study.
After examining the panoramic radiographs, patients who underwent extraction were included in Classes 1 and II, Positions A and B according to Pell-Gregory 16 classification, and mesioangular and vertical positions according to the Winter 17 classification.
Each patient was examined by the researcher. The patients were informed about the procedure, and written informed consent was obtained from the patient's preoperative assessment clinic. If a patient had additional questions, they were included as part of the investigation.
The patients were divided into three groups:
Group 1: Patients who were given only basic information verbally Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods Group 3: Patients with previous experience and knowledge about third molar extraction Previous experience was determined before giving the questionnaires. The patients were randomly assigned to group 1 or 2 using an online random allocation software (www.randomization.com). Information was provided on how to complete questionnaires. STAI-S, MDAS, DFS, and VAS were applied to all patients 15 min before the surgery in the waiting room. The demographic data section (age and sex) in the form was filled out by the researcher.
The surgery was carried out under local anesthesia, with no pharmaceutical premedication or sedation. The surgical procedures were performed by a single experienced surgeon in the oral surgery clinic. After the surgery was completed, the patients were taken to the waiting room, and prescribed medications were given. STAI-S, MDAS, DFS, and VAS were reapplied after the surgery.
- Conditions
- Dental Anxiety
- Being tested
- Spielberger State Anxiety Inventory (STAI-S),, Dental Fear Scale (DFS), Modified Dental Anxiety Scale (MDAS), Visual Analog Scale (VAS)
- Keywords
- third molar extraction, Preoperative anxiety, Dental Anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spielberger State Anxiety Inventory (STAI-S),Behavioural
STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
Dental Fear Scale (DFS)Behavioural
DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice
Modified Dental Anxiety Scale (MDAS)Behavioural
MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25
Visual Analog Scale (VAS)Behavioural
VAS is ideal for evaluating situations that cannot be measured using digital and oral information. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as "no anxiety" and the other end as "maximum anxiety imaginable
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1: Patients who were given only basic information verbally Receives: Behavioral: Spielberger State Anxiety Inventory (STAI-S),; Behavioral: Dental Fear Scale (DFS); Behavioral: Modified Dental Anxiety Scale (MDAS); Behavioral: Visual Analog Scale (VAS) |
| Group 2 | Experimental | Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods Receives: Behavioral: Spielberger State Anxiety Inventory (STAI-S),; Behavioral: Dental Fear Scale (DFS); Behavioral: Modified Dental Anxiety Scale (MDAS); Behavioral: Visual Analog Scale (VAS) |
| Group 3 | Experimental | Group 3: Patients with previous experience and knowledge about third molar extraction Receives: Behavioral: Spielberger State Anxiety Inventory (STAI-S),; Behavioral: Dental Fear Scale (DFS); Behavioral: Modified Dental Anxiety Scale (MDAS); Behavioral: Visual Analog Scale (VAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively
Spielberger State Anxiety Inventory (STAI) is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety. The inventory has 2 different scales, each with 20 items, showing the state and trait anxiety levels: STAI-state is used to determine a patient's current anxiety level, and STAI-trait is used to determine a patient's underlying (ongoing/personality) anxiety level. All 20 items are rated on a 4-point scale. The total score obtained can range from 20 to 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). We used only STAI-S
Measured: 2 minutes
Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice
Measured: 2 minutes
Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25
Measured: 1 minute
Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
VAS is ideal for evaluating situations that cannot be measured using digital and oral information 25. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as "no anxiety" and the other end as "maximum anxiety imaginable."
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start15 Sep 2018
- Primary completion15 Dec 2018
- Study completion5 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser Sancak, Ankara University
- Investigators
- Kevser Sancak, Study chair, Ankara University Faculty of Dentısry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838081
- Sponsor's protocol ID
- 36290600/69
- Status last verified
- Feb 2019
- First submitted
- 10 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muglali M, Komerik N. Factors related to patients' anxiety before and after oral surgery. J Oral Maxillofac Surg. 2008 May;66(5):870-7. doi: 10.1016/j.joms.2007.06.662.
PubMed 18423273Jaakkola S, Rautava P, Alanen P, Aromaa M, Pienihakkinen K, Raiha H, Vahlberg T, Mattila ML, Sillanpaa M. Dental fear: one single clinical question for measurement. Open Dent J. 2009 Jul 28;3:161-6. doi: 10.2174/1874210600903010161.
PubMed 19672334Pell GJ. Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933;39:330-338.
Winter GB. Principles of exodontia as applied to the impacted mandibular third molar. American Medical Book Company; 1926.
Ost L-g, Öst L-G, Skaret E. Cognitive behavioral therapy for dental phobia and anxiety. John Wiley & Sons; 2013
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Verbal & Written Information and the Previous Surgical Experience on the Anxiety of Third Molar Extraction
- ClinicalTrials.gov ID
- NCT03838081
- Acronym / sponsor ID
- 36290600/69
- Conditions
- Dental Anxiety
- Keywords
- third molar extraction, Preoperative anxiety, Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 5 Jan 2019 (actual)
- First posted
- 12 Feb 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.
This study was performed on 66 patients who were admitted for third molar extraction under local anesthesia. The patients were divided into three groups: group 1 with verbal information, group 2 with written information, and group 3 with previous surgical experience. Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental Anxiety Scale (MDAS), and Visual Analog Scale (VAS) were used pre- and postoperatively to evaluate dental anxiety
Detailed description
This prospective study included 66 patients who underwent third molar extraction under local anesthesia in the Oral and Maxillofacial Department, Faculty of Dentistry, Ankara University, Turkey, between September and November 2018. The research protocol was approved by the ethical committee of the institute (No: 36290600/69), Ankara University, Turkey.
Spielberger State Anxiety Inventory (STAI-S), Dental Fear Scale (DFS), Modified Dental Anxiety Scale (MDAS), and Visual Analog Scale (VAS) are commonly used questionnaires for dental anxiety. The latter asked only about age and sex. They were used together before and immediately after surgery to obtain better results in this study.
After examining the panoramic radiographs, patients who underwent extraction were included in Classes 1 and II, Positions A and B according to Pell-Gregory 16 classification, and mesioangular and vertical positions according to the Winter 17 classification.
Each patient was examined by the researcher. The patients were informed about the procedure, and written informed consent was obtained from the patient's preoperative assessment clinic. If a patient had additional questions, they were included as part of the investigation.
The patients were divided into three groups:
Group 1: Patients who were given only basic information verbally Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods Group 3: Patients with previous experience and knowledge about third molar extraction Previous experience was determined before giving the questionnaires. The patients were randomly assigned to group 1 or 2 using an online random allocation software (www.randomization.com). Information was provided on how to complete questionnaires. STAI-S, MDAS, DFS, and VAS were applied to all patients 15 min before the surgery in the waiting room. The demographic data section (age and sex) in the form was filled out by the researcher.
The surgery was carried out under local anesthesia, with no pharmaceutical premedication or sedation. The surgical procedures were performed by a single experienced surgeon in the oral surgery clinic. After the surgery was completed, the patients were taken to the waiting room, and prescribed medications were given. STAI-S, MDAS, DFS, and VAS were reapplied after the surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Spielberger State Anxiety Inventory (STAI-S),, Behavioral: Dental Fear Scale (DFS), Behavioral: Modified Dental Anxiety Scale (MDAS), Behavioral: Visual Analog Scale (VAS)Group 1: Patients who were given only basic information verbally |
| Group 2 | Experimental | Behavioral: Spielberger State Anxiety Inventory (STAI-S),, Behavioral: Dental Fear Scale (DFS), Behavioral: Modified Dental Anxiety Scale (MDAS), Behavioral: Visual Analog Scale (VAS)Group 2: Patients with detailed written information about preoperative, intraoperative, and postoperative periods |
| Group 3 | Experimental | Behavioral: Spielberger State Anxiety Inventory (STAI-S),, Behavioral: Dental Fear Scale (DFS), Behavioral: Modified Dental Anxiety Scale (MDAS), Behavioral: Visual Analog Scale (VAS)Group 3: Patients with previous experience and knowledge about third molar extraction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-80 years
- American Society of Anesthesiologists physical status score I and II
- Patients without any systemic disease, or regular medication use.
Key exclusion criteria (3 listed)
- İnability to read and understand Turkish
- Significantly impaired eyesight or hearing, an existing psychiatric disorder
- Patients aged less than 18 years
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 |
|---|---|---|
| Spielberger State Anxiety Inventory (STAI-S),STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety | Behavioural | Group 1, Group 2, Group 3 |
| Dental Fear Scale (DFS)DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice | Behavioural | Group 1, Group 2, Group 3 |
| Modified Dental Anxiety Scale (MDAS)MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25 | Behavioural | Group 1, Group 2, Group 3 |
| Visual Analog Scale (VAS)VAS is ideal for evaluating situations that cannot be measured using digital and oral information. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as "no anxiety" and the other end as "maximum anxiety imaginable | Behavioural | Group 1, Group 2, Group 3 |
Primary outcome
Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively
Time frame: 2 minutes
Spielberger State Anxiety Inventory (STAI) is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety. The inventory has 2 different scales, each with 20 items, showing the state and trait anxiety levels: STAI-state is used to determine a patient's current anxiety level, and STAI-trait is used to determine a patient's underlying (ongoing/personality) anxiety level. All 20 items are rated on a 4-point scale. The total score obtained can range from 20 to 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). We used only STAI-S
Evaluation of anxiety with Dental Fear Survey(DFS) between groups preoperatively and postoperatively
Time frame: 2 minutes
DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice
Evaluation of anxiety with Modified Dental Anxiety Scale(MDAS) between groups preoperatively and postoperatively
Time frame: 1 minute
MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25
Evaluation of anxiety with Visual Analog Scale (VAS) between groups preoperatively and postoperatively
Time frame: 1 minute
VAS is ideal for evaluating situations that cannot be measured using digital and oral information 25. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as "no anxiety" and the other end as "maximum anxiety imaginable."
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 15 Feb 2019.
- Background: PubMed 18423273Muglali M, Komerik N. Factors related to patients' anxiety before and after oral surgery. J Oral Maxillofac Surg. 2008 May;66(5):870-7. doi: 10.1016/j.joms.2007.06.662.
- Background: PubMed 19672334Jaakkola S, Rautava P, Alanen P, Aromaa M, Pienihakkinen K, Raiha H, Vahlberg T, Mattila ML, Sillanpaa M. Dental fear: one single clinical question for measurement. Open Dent J. 2009 Jul 28;3:161-6. doi: 10.2174/1874210600903010161.
- BackgroundPell GJ. Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933;39:330-338.
- BackgroundWinter GB. Principles of exodontia as applied to the impacted mandibular third molar. American Medical Book Company; 1926.
- BackgroundOst L-g, Öst L-G, Skaret E. Cognitive behavioral therapy for dental phobia and anxiety. John Wiley & Sons; 2013
- Individual participant dataSharing planned: No
Related trials for Dental Anxiety
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
Bruxism, Anxiety
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Active, not recruiting
Musical Intervention for Dental Anxiety
Dental Anxiety
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.
Kevser Sancak study chair
Ankara University Faculty of Dentısry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spielberger State Anxiety Inventory (STAI-S),, Dental Fear Scale (DFS) and Modified Dental Anxiety Scale (MDAS) in people with Dental Anxiety, run by Ankara 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 3 inclusion and 3 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 15 Feb 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?
Evaluation of anxiety with Spielberger State Anxiety Inventory(STAI-S) between groups preoperatively and postoperatively (time frame: 2 minutes). 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?
On the ClinicalTrials.gov record for NCT03838081, which also lists 5 linked publications.
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 15 Feb 2019.