Dental AnxietyNCT03876613
Different Music Types in Reducing Dental Anxiety in Young People
A study testing Different music types in people with Dental Anxiety, run by Erzincan University.
Trial summary
Anxiety is an important issue in dental care for adults, children and adolescents. Dental anxiety affects 10-20% of adults and 43% of children and adolescents. Dental anxiety often leads to avoiding dental treatment; this can cause serious deterioration of oral and dental health. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Different music types
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2019to 15 Jan 2020
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 3. Molar tooth extraction,
- 18-30 years old,
- Symptomatic
Who cannot join
- Who does not agree to participate in the study,
- Under 18 years, over 30 years,
- patients with impaired hearing (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: Comparison of Different Music Types in Reducing Dental Anxiety in Young People Undergoing Third Molar Tooth Surgery - A Randomized Controlled Study
Anxiety is an important issue in dental care for adults, children and adolescents. Dental anxiety affects 10-20% of adults and 43% of children and adolescents. Dental anxiety often leads to avoiding dental treatment; this can cause serious deterioration of oral and dental health. Such deterioration can significantly increase dental care costs. Therefore, reducing anxiety is important both in terms of patient, physician and cost. Music intervention is a psychological therapy that has many advantages when used in outpatient treatment, including cost-effectiveness, lack of negative physical effects, rapid effect, lack of safety in terms of non-use and lack of concern for recovery. Some types of studies suggested but not tested against each other include classical music, soft rock, calming music, pop, easy listening music, and music of choice.
With the contradictory results of various studies, the fact that the distraction of music and its distraction on the reduction of tooth anxiety is not common shows that a more structured study is needed. The lack of precise data on the effects of different music types on anxiety has led to this study.
- Conditions
- Dental Anxiety
- Being tested
- Different music types
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different music typesBehavioural
the type of music that reduces anxiety best and most effectively.
| Study group | Role | What they receive |
|---|---|---|
| Turkish music group | Active comparator | Rast makam Receives: Behavioral: Different music types |
| classical western music | Active comparator | Vivaldi Receives: Behavioral: Different music types |
| soft rock music | Active comparator | Elvis presley Receives: Behavioral: Different music types |
| control group | Placebo comparator | No music Receives: Behavioral: Different music types |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the patients with anxiety
the type of music that reduces anxiety best and most effectively.
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 posted15 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 (3)Papers the sponsor has linked to this study.
- Other trials for Dental 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
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
- NCT03876613
- Sponsor's protocol ID
- EBYU
- Status last verified
- Jul 2019
- First submitted
- 8 Mar 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Almoznino G, Zini A, Sharav Y, Shahar A, Zlutzky H, Haviv Y, Lvovsky A, Aframian DJ. Sleep quality in patients with dental anxiety. J Psychiatr Res. 2015 Feb;61:214-22. doi: 10.1016/j.jpsychires.2014.11.015. Epub 2014 Dec 9.
PubMed 25529787Gordon D, Heimberg RG, Tellez M, Ismail AI. A critical review of approaches to the treatment of dental anxiety in adults. J Anxiety Disord. 2013 May;27(4):365-78. doi: 10.1016/j.janxdis.2013.04.002. Epub 2013 Apr 13.
PubMed 23746494Shim YS, Kim AH, Jeon EY, An SY. Dental fear & anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30.
PubMed 28879259
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Music Types in Reducing Dental Anxiety in Young People Undergoing Third Molar Tooth Surgery - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03876613
- Acronym / sponsor ID
- EBYU
- Conditions
- Dental Anxiety
- Study type
- Interventional
- 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
- 15 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.
Anxiety is an important issue in dental care for adults, children and adolescents. Dental anxiety affects 10-20% of adults and 43% of children and adolescents. Dental anxiety often leads to avoiding dental treatment; this can cause serious deterioration of oral and dental health. Such deterioration can significantly increase dental care costs. Therefore, reducing anxiety is important both in terms of patient, physician and cost. Music intervention is a psychological therapy that has many advantages when used in outpatient treatment, including cost-effectiveness, lack of negative physical effects, rapid effect, lack of safety in terms of non-use and lack of concern for recovery. Some types of studies suggested but not tested against each other include classical music, soft rock, calming music, pop, easy listening music, and music of choice.
With the contradictory results of various studies, the fact that the distraction of music and its distraction on the reduction of tooth anxiety is not common shows that a more structured study is needed. The lack of precise data on the effects of different music types on anxiety has led to this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Turkish music group | Active comparator | Behavioral: Different music typesRast makam |
| classical western music | Active comparator | Behavioral: Different music typesVivaldi |
| soft rock music | Active comparator | Behavioral: Different music typesElvis presley |
| control group | Placebo comparator | Behavioral: Different music typesNo music |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 3. Molar tooth extraction,
- 18-30 years old,
- Symptomatic
Key exclusion criteria (5 listed)
- Who does not agree to participate in the study,
- Under 18 years, over 30 years,
- patients with impaired hearing (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 |
|---|---|---|
| Different music typesthe type of music that reduces anxiety best and most effectively. | Behavioural | Turkish music group, classical western music, control group, soft rock music |
Primary outcome
Number of the patients with anxiety
Time frame: six month
the type of music that reduces anxiety best and most effectively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 25529787Almoznino G, Zini A, Sharav Y, Shahar A, Zlutzky H, Haviv Y, Lvovsky A, Aframian DJ. Sleep quality in patients with dental anxiety. J Psychiatr Res. 2015 Feb;61:214-22. doi: 10.1016/j.jpsychires.2014.11.015. Epub 2014 Dec 9.
- Results publication: PubMed 23746494Gordon D, Heimberg RG, Tellez M, Ismail AI. A critical review of approaches to the treatment of dental anxiety in adults. J Anxiety Disord. 2013 May;27(4):365-78. doi: 10.1016/j.janxdis.2013.04.002. Epub 2013 Apr 13.
- Results publication: PubMed 28879259Shim YS, Kim AH, Jeon EY, An SY. Dental fear & anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30.
- 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?
A study testing Different music types in people with Dental Anxiety, 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 3 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 16 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. 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?
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?
Number of the patients with anxiety (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 NCT03876613, which also lists 3 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 16 Jul 2019.