Impacted Third Molar ToothNCT03752255
Verbal and Visual Information Techniques on Anxiety in Third Molar Surgery
A study testing Anxiety measurement method in people with Impacted Third Molar Tooth, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate preoperative anxiety levels using dental anxiety scale (DAS) and the Spielberger State-Trait Anxiety Inventory (STAI). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Anxiety measurement method
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2018to 21 Dec 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Impacted third molar (bone and mucosa retention, mesioangular position)
- Patients with any chronic disease and allergy
Who cannot join
- Pericoronitis
- Patients with visual impairment
- Patients with psychological disorders
- Smoking
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Karatay, 42050
About this study
Official title: The Effects of Verbal and Visual Information Techniques on Anxiety in Impacted Third Molar Surgery
The aim of this study was to evaluate preoperative anxiety levels using dental anxiety scale (DAS) and the Spielberger State-Trait Anxiety Inventory (STAI).
Read the detailed description
This study will based on a prospective, observational investigation of two different patient education techniques about the effect of third molar removal on patients' anxiety level. A total of 240 patients will be divided into two groups.
Information about operation procedures and a recovery will be given verbally in group 1 and information about operation procedures and recovery will be given in group 2. Anxiety levels were assessed by using DAS and (STAI).Paired t-test or Wilcoxon test will be used for intra-group comparison of anxiety levels.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Anxiety measurement method
- Keywords
- Video, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety measurement methodOther
Two different techniques (video or verbal information) will be examined about impacted third molar surgery.
| Study group | Role | What they receive |
|---|---|---|
| Anxiety measurement method | Experimental | Before the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). Then patients will watch a video about impacted tooth. This video will include the complications that patients may face and what should be done after the procedure. After the watching the video, patients will fill the both DAS and STAI. Receives: Other: Anxiety measurement method |
| Control | Placebo comparator | Before the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). The verbal information in detail will be given to the patients by the surgeon.This verbal information will include the complications that patients may face and what should be done after the procedure. Receives: Other: Anxiety measurement method |
What is being measured
The primary outcome is the main question the study is designed to answer.
The anxiety levels will be examined using DAS and STAI.
first day
Measured: first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start21 Nov 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Menziletoglu, Konya Necmettin Erbakan Üniversitesi
- Investigators
- Dilek Menziletoglu, Dr, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752255
- Sponsor's protocol ID
- NEU2
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Verbal and Visual Information Techniques on Anxiety in Impacted Third Molar Surgery
- ClinicalTrials.gov ID
- NCT03752255
- Acronym / sponsor ID
- NEU2
- Conditions
- Impacted Third Molar Tooth
- Keywords
- Video, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 23 Nov 2018 (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.
The aim of this study was to evaluate preoperative anxiety levels using dental anxiety scale (DAS) and the Spielberger State-Trait Anxiety Inventory (STAI).
Detailed description
This study will based on a prospective, observational investigation of two different patient education techniques about the effect of third molar removal on patients' anxiety level. A total of 240 patients will be divided into two groups.
Information about operation procedures and a recovery will be given verbally in group 1 and information about operation procedures and recovery will be given in group 2. Anxiety levels were assessed by using DAS and (STAI).Paired t-test or Wilcoxon test will be used for intra-group comparison of anxiety levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxiety measurement method | Experimental | Other: Anxiety measurement methodBefore the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). Then patients will watch a video about impacted tooth. This video will include the complications that patients may face and what should be done after the procedure. After the watching the video, patients will fill the both DAS and STAI. |
| Control | Placebo comparator | Other: Anxiety measurement methodBefore the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). The verbal information in detail will be given to the patients by the surgeon.This verbal information will include the complications that patients may face and what should be done after the procedure. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Impacted third molar (bone and mucosa retention, mesioangular position)
- Patients with any chronic disease and allergy
Key exclusion criteria (5 listed)
- Pericoronitis
- Patients with visual impairment
- Patients with psychological disorders
- Smoking
- Pregnancy or lactation
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 |
|---|---|---|
| Anxiety measurement methodTwo different techniques (video or verbal information) will be examined about impacted third molar surgery. | Other | Anxiety measurement method, Control |
Primary outcome
The anxiety levels will be examined using DAS and STAI.
Time frame: first day
first day
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 Dec 2018.
Related trials for Impacted Third Molar Tooth
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect
RecruitingObservational study
Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
Stomatognatic, Tooth Diseases
Recruiting
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
Not yet recruiting
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
Impacted Third Molar Tooth, Surgical Wound Healing
Active, not recruiting
Chlorhexidine Versus Normal Saline Socket Irrigation for Prevention of Dry Socket After Lower Wisdom Tooth Extraction
Alveolar Osteitis, Impacted Lower Third Molar
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.
Dilek Menziletoglu, Dr principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety measurement method in people with Impacted Third Molar Tooth, run by Konya Necmettin Erbakan Üniversitesi 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 2 inclusion and 5 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 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
The anxiety levels will be examined using DAS and STAI. (time frame: first day). 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 Dec 2018.