Anxiety, DentalNCT03943836
Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy
A study testing Music in people with Anxiety, Dental, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine if passive music listening decreases anxiety in patients undergoing dental procedures and if the effects of music therapy are influenced by gender, age, and amount or type of dental treatment needed. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Anxiety, Dental
- 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
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2019to 8 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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists Physical Status Classification System I (ASA I) I and American Society of Anesthesiologists Physical Status Classification System II (ASA II)
- Patient needs restorative procedure (with or without local anesthesia or nitrous oxide)
- Received previous dental restorative treatment (detected via visual or radiographic evidence of previous restoration - no additional radiographs will be exposed for this study; exposed radiographs will be previously obtained, as needed,for comprehensive or periodic dental reasons)
Who cannot join
- Patients with hearing impairments
- Uncooperative patients at examination appointment (detected by Frankl behavior score of 1 or 2)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Reducing Anxiety in Pediatric Dental Patient Through Passive Musical Therapy
The purpose of this study is to determine if passive music listening decreases anxiety in patients undergoing dental procedures and if the effects of music therapy are influenced by gender, age, and amount or type of dental treatment needed.
- Conditions
- Anxiety, Dental
- Being tested
- Music
- Keywords
- Dental Anxiety, Pediatric dentistry
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Patients in the music group will listen to classical music during their dental procedure.
| Study group | Role | What they receive |
|---|---|---|
| Music Group | Experimental | Patients listen to music Receives: Behavioral: Music |
| No Music group | No intervention | Patients do not listen to music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety as assessed by the Pediatric 7 question survey
The total score ranges from 7-49, with lower scores indicating less anxiety.
Measured: baseline
Anxiety as assessed by the Pediatric 7 question survey
The total score ranges from 7-49, with lower scores indicating less anxiety.
Measured: immediately after the dental procedure (within 5 minutes after procedure)
Parent's prediction of child's anxiety in the dental office as assessed by survey
The total score ranges from 0-10. A lower score indicates less anxiety.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start9 Jul 2019
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
Why it stopped: PI, who was a Resident, graduated, and the project was not pursued further.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety, DentalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Thomas Chiquet, The University of Texas Health Science Center, Houston
- Investigators
- Nancy Ly, DDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943836
- Sponsor's protocol ID
- HSC-DB-19-0220
- Status last verified
- Mar 2022
- First submitted
- 7 May 2019
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Anxiety in Pediatric Dental Patient Through Passive Musical Therapy
- ClinicalTrials.gov ID
- NCT03943836
- Acronym / sponsor ID
- HSC-DB-19-0220
- Conditions
- Anxiety, Dental
- Keywords
- Dental Anxiety, Pediatric dentistry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI, who was a Resident, graduated, and the project was not pursued further.
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 9 May 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.
The purpose of this study is to determine if passive music listening decreases anxiety in patients undergoing dental procedures and if the effects of music therapy are influenced by gender, age, and amount or type of dental treatment needed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Behavioral: MusicPatients listen to music |
| No Music group | No intervention | –Patients do not listen to music |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists Physical Status Classification System I (ASA I) I and American Society of Anesthesiologists Physical Status Classification System II (ASA II)
- Patient needs restorative procedure (with or without local anesthesia or nitrous oxide)
- Received previous dental restorative treatment (detected via visual or radiographic evidence of previous restoration - no additional radiographs will be exposed for this study; exposed radiographs will be previously obtained, as needed,for comprehensive or periodic dental reasons)
Key exclusion criteria (2 listed)
- Patients with hearing impairments
- Uncooperative patients at examination appointment (detected by Frankl behavior score of 1 or 2)
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 |
|---|---|---|
| MusicPatients in the music group will listen to classical music during their dental procedure. | Behavioural | Music Group |
Primary outcome
Anxiety as assessed by the Pediatric 7 question survey
Time frame: baseline
The total score ranges from 7-49, with lower scores indicating less anxiety.
Anxiety as assessed by the Pediatric 7 question survey
Time frame: immediately after the dental procedure (within 5 minutes after procedure)
The total score ranges from 7-49, with lower scores indicating less anxiety.
Parent's prediction of child's anxiety in the dental office as assessed by survey
Time frame: baseline
The total score ranges from 0-10. A lower score indicates less anxiety.
Results and safety
The study was stopped early (reason given: PI, who was a Resident, graduated, and the project was not pursued further.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Nancy Ly, DDS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Anxiety, Dental, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 11 Apr 2022. 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 United States. 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 was stopped early (reason given: PI, who was a Resident, graduated, and the project was not pursued further.). Results are not available in the source record.
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?
Anxiety as assessed by the Pediatric 7 question survey (time frame: baseline). The study lists 3 primary outcomes in all. 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 11 Apr 2022.