Dental AnxietyPhase 2/3NCT01622374
Effects of "Music for the Mind" on Pre-operative Anxiety in Dentistry
A Phase 2/3 study testing Music in people with Dental Anxiety, run by Azad University of Medical Sciences.
Trial summary
To examine the pre-operative effect of music for the mind compared to some other styles of music in patients undergoing dental procedures. Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Apr 2011
- Phase
- Phase 2/3
- 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 17 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- need for dental treatments
Who cannot join
- usage of anxiety drugs
- usage of psychoactive drugs
- emergency cases
About this study
Official title: a Randomized Controlled Clinical Trial on the Effects of "Music for the Mind" on Pre-operative Anxiety in Dentistry
To examine the pre-operative effect of music for the mind compared to some other styles of music in patients undergoing dental procedures.
Read the detailed description
120 patients were sequentially assigned to four groups of 30 subjects. the music groups received Music for the mind, Iranian traditional music and Mozart music through headphone for ten minutes prior to dental procedures, and the control group received silence through headphone. anxiety score and pulse rate and blood pressure were measured before and after receiving music
- Conditions
- Dental Anxiety
- Being tested
- Music
- Keywords
- Music, dental anxiety, "music for the mind", mozart, iranian traditional music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Also called Music for the mind, Mozart Music, Iranian Music
Ten minutes of music or silence were applied prior to dental procedures
| Study group | Role | What they receive |
|---|---|---|
| Silence | Active comparator | the subjects received 10 minutes of silence through headphone Receives: Behavioral: Music |
| Music for the mind | Experimental | Not described Receives: Behavioral: Music |
| Mozart music | Experimental | Not described Receives: Behavioral: Music |
| Iranian traditional music | Experimental | Not described Receives: Behavioral: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAI Inventory
The level of anxiety was measured by STAI Inventory index immediately after the intervention
Measured: 5 minutes
Secondary outcomes (3)
Heart rate
The index was measured before and after the intervention
Measured: 30 seconds
Systolic blood pressure
The index was measured before and after the intervention
Measured: 30 seconds
Diastolic blood pressure
The index was measured before and after the intervention
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aminpasha Samadian, Azad University of Medical Sciences
- Investigators
- Aminpasha Samadian, DDS, Study chair, Azad university of medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622374
- Sponsor's protocol ID
- Aminpasha_CT0001
- Status last verified
- Jun 2012
- First submitted
- 14 Jun 2012
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Randomized Controlled Clinical Trial on the Effects of "Music for the Mind" on Pre-operative Anxiety in Dentistry
- ClinicalTrials.gov ID
- NCT01622374
- Acronym / sponsor ID
- Aminpasha_CT0001
- Conditions
- Dental Anxiety
- Keywords
- Music, dental anxiety, "music for the mind", mozart, iranian traditional music
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Azad University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 Jun 2012 (estimated)
- 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.
To examine the pre-operative effect of music for the mind compared to some other styles of music in patients undergoing dental procedures.
Detailed description
120 patients were sequentially assigned to four groups of 30 subjects. the music groups received Music for the mind, Iranian traditional music and Mozart music through headphone for ten minutes prior to dental procedures, and the control group received silence through headphone. anxiety score and pulse rate and blood pressure were measured before and after receiving music
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Silence | Active comparator | Behavioral: Musicthe subjects received 10 minutes of silence through headphone |
| Music for the mind | Experimental | Behavioral: Music |
| Mozart music | Experimental | Behavioral: Music |
| Iranian traditional music | Experimental | Behavioral: Music |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- need for dental treatments
Key exclusion criteria (3 listed)
- usage of anxiety drugs
- usage of psychoactive drugs
- emergency cases
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 |
|---|---|---|
| MusicAlso: Music for the mind, Mozart Music, Iranian MusicTen minutes of music or silence were applied prior to dental procedures | Behavioural | Iranian traditional music, Mozart music, Music for the mind, Silence |
Primary outcome
STAI Inventory
Time frame: 5 minutes
The level of anxiety was measured by STAI Inventory index immediately after the intervention
3 secondary outcomes
Heart rate
Time frame: 30 seconds
Systolic blood pressure
Time frame: 30 seconds
Diastolic blood pressure
Time frame: 30 seconds
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 19 Jun 2012.
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.
Aminpasha Samadian, DDS study chair
Azad university of medical science
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Music in people with Dental Anxiety, run by Azad University of Medical Sciences.
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 1 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 19 Jun 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
STAI Inventory (time frame: 5 minutes). 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 19 Jun 2012.