Anxiety, DentalNCT03872934
Effect of Different Music Types on Implant Surgery Anxiety
An observational study of Anxiety, Dental, run by Erzincan University.
Trial summary
A general term, dental anxiety, is defined as fear or an abnormal concern to visit the dentist for unwanted concerns about preventive care and dental procedures. anxiety; dental examinations or treatment can be prevented or postponed. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Anxiety, Dental
- What is being tested?
- implant anxiety
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2019to 15 Jan 2020
- How long will I take part?
- 6 Months
- 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 40 to 70 years
- All sexes
- Adult, Older adult
Study population: Eighty patients aged 40-70 years will undergo elective implant surgery.
Who may be able to join
- Will undergo elective implant surgery,
- between 40-70 years
Who cannot join
- Who does not agree to participate in the study,
- Under 40, over 70 years,
- Patients with ear disorders (ie, not suitable for musical intervention),
- arrhythmia
- patients with physical condition III or higher (American Society of Anesthesiologists)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Different Music Types on Implant Surgery Anxiety - Randomized Controlled Study
A general term, dental anxiety, is defined as fear or an abnormal concern to visit the dentist for unwanted concerns about preventive care and dental procedures. anxiety; dental examinations or treatment can be prevented or postponed.
This delay in dentistry typically leads to much more serious dental problems, often leading to more expensive, more invasive and possibly emergency treatment. Therefore, reducing anxiety is important both in terms of patient, physician and cost.
- Conditions
- Anxiety, Dental
- Being tested
- implant 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.
implant anxietyBehavioural
to determine the type of music that reduces anxiety in patients undergoing implant surgery.
| Study group | Role | What they receive |
|---|---|---|
| Turkish music group | Turkish music group (Saba or rast makam) Receives: Behavioral: implant anxiety | |
| classical western music | classical western music (vivaldi) Receives: Behavioral: implant anxiety | |
| soft rock music | soft rock music (elvis) Receives: Behavioral: implant anxiety | |
| control group (group not listening music) | control Receives: Behavioral: implant anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corah's dental anxiety scale
the type of music that reduces anxiety in patients undergoing implant surgery.
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start15 Jul 2019 (estimated)
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anxiety, DentalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
- Investigators
- ilke kupeli, Principal investigator, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872934
- Sponsor's protocol ID
- EBYU 1
- Status last verified
- Jul 2019
- First submitted
- 8 Mar 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Miyata K, Odanaka H, Nitta Y, Shimoji S, Kanehira T, Kawanami M, Fujisawa T. Music before Dental Surgery Suppresses Sympathetic Activity Derived from Preoperative Anxiety: A Randomized Controlled Trial. JDR Clin Trans Res. 2016 Jul;1(2):153-162. doi: 10.1177/2380084416650613.
PubMed 30931796Bodner E, Iancu I. Recalling the threat: dental anxiety in patients waiting for dental surgery. Isr J Psychiatry Relat Sci. 2013;50(1):61-6.
PubMed 24029113Thoma MV, Zemp M, Kreienbuhl L, Hofer D, Schmidlin PR, Attin T, Ehlert U, Nater UM. Effects of Music Listening on Pre-treatment Anxiety and Stress Levels in a Dental Hygiene Recall Population. Int J Behav Med. 2015 Aug;22(4):498-505. doi: 10.1007/s12529-014-9439-x.
PubMed 25200448Wright H. The Correlation of Classical, Jazz, and Pop Music to a Reduction of Dental Anxiety Experienced by Adult Patients. 2018.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Music Types on Implant Surgery Anxiety - Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03872934
- Acronym / sponsor ID
- EBYU 1
- Conditions
- Anxiety, Dental
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (estimated)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Jan 2020 (estimated)
- First posted
- 13 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.
A general term, dental anxiety, is defined as fear or an abnormal concern to visit the dentist for unwanted concerns about preventive care and dental procedures. anxiety; dental examinations or treatment can be prevented or postponed.
This delay in dentistry typically leads to much more serious dental problems, often leading to more expensive, more invasive and possibly emergency treatment. Therefore, reducing anxiety is important both in terms of patient, physician and cost.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Turkish music group | – | Behavioral: implant anxietyTurkish music group (Saba or rast makam) |
| classical western music | – | Behavioral: implant anxietyclassical western music (vivaldi) |
| soft rock music | – | Behavioral: implant anxietysoft rock music (elvis) |
| control group (group not listening music) | – | Behavioral: implant anxietycontrol |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eighty patients aged 40-70 years will undergo elective implant surgery.
Key inclusion criteria (2 listed)
- Will undergo elective implant surgery,
- between 40-70 years
Key exclusion criteria (5 listed)
- Who does not agree to participate in the study,
- Under 40, over 70 years,
- Patients with ear disorders (ie, not suitable for musical intervention),
- arrhythmia
- patients with physical condition III or higher (American Society of Anesthesiologists)
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 |
|---|---|---|
| implant anxietyto determine the type of music that reduces anxiety in patients undergoing implant surgery. | Behavioural | Turkish music group, classical western music, control group (group not listening music), soft rock music |
Primary outcome
Corah's dental anxiety scale
Time frame: six month
the type of music that reduces anxiety in patients undergoing implant surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Results publication: PubMed 30931796Miyata K, Odanaka H, Nitta Y, Shimoji S, Kanehira T, Kawanami M, Fujisawa T. Music before Dental Surgery Suppresses Sympathetic Activity Derived from Preoperative Anxiety: A Randomized Controlled Trial. JDR Clin Trans Res. 2016 Jul;1(2):153-162. doi: 10.1177/2380084416650613.
- Results publication: PubMed 24029113Bodner E, Iancu I. Recalling the threat: dental anxiety in patients waiting for dental surgery. Isr J Psychiatry Relat Sci. 2013;50(1):61-6.
- Results publication: PubMed 25200448Thoma MV, Zemp M, Kreienbuhl L, Hofer D, Schmidlin PR, Attin T, Ehlert U, Nater UM. Effects of Music Listening on Pre-treatment Anxiety and Stress Levels in a Dental Hygiene Recall Population. Int J Behav Med. 2015 Aug;22(4):498-505. doi: 10.1007/s12529-014-9439-x.
- Results publicationWright H. The Correlation of Classical, Jazz, and Pop Music to a Reduction of Dental Anxiety Experienced by Adult Patients. 2018.
- Encyclopedia of Medical Concepts. Reference. MD website.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
ilke kupeli principal investigator
Erzincan University
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, Dental, run by Erzincan University.
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: status not confirmed, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilke kupeli (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corah's dental anxiety scale (time frame: six month). 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 NCT03872934, which also lists 4 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 Jul 2019.