Personalized Musical InterventionNCT04099264
Effect of Music on Burden of Dental Implant Surgery
A study testing Personalized music and Audio Books in people with Personalized Musical Intervention, run by Université de Montréal at 1 site in Canada.
Trial summary
Personnalized music can decrease the burden of care. This experimental clinical trial examines the effect of personalized musical intervention on the burden of dental implant surgery. The intervention consists of a personnalized musical intervention and the control group consists of audio books. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Personalized Musical Intervention
- What is being tested?
- Personalized music and Audio Books
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 12 Oct 2018to 21 Mar 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients included in the study:
- will have an adequate understanding of the French or English language both written and spoken,
- will have the physical and psychological ability to understand and complete the questionnaires used in the study,
- will consent to follow research instructions,
- will consent to follow the allocated sequence of interventions without prior notification,
- will undergo a dental implant surgery not exceeding 2 hours,
Who cannot join
- Patients :
- do not have the necessary clinical criteria to receive implants.
- have an implant surgical treatment that would increase treatment time beyond 2 hours,
- have a history of neurological disorders, diagnosed with severe psychiatric disorders (e.g. schizophrenia, bipolar disorder), substance abuse
- have a major diagnosed hearing problem.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Personalized Musical Intervention on Burden of Care in Dental Implant Surgery: A Pilot Randomized Controlled Trial
Personnalized music can decrease the burden of care.
This experimental clinical trial examines the effect of personalized musical intervention on the burden of dental implant surgery. The intervention consists of a personnalized musical intervention and the control group consists of audio books. The burden of dental implant surgery will be defined by a composite variable including surgical pain, state anxiety and dissatisfaction with dental implant surgery.
- Conditions
- Personalized Musical Intervention
- Being tested
- Personalized music, Audio Books
- Keywords
- personalized musical intervention, experimental study, dissatisfaction, anxiety, surgical pain, burden of care, pilot randomized controlled trial
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized musicOther
Patients in the intervention group will listen to personalized music from the Musicare application
Audio BooksOther
Patients in the active comparator group will listen to audio books
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Personalized music | Experimental | This arm will receive an intervention which will be personalized music. It will be provided by Music Care application (https://www.music-care.com/fr). Receives: Other: Personalized music |
| Control: Audio Books | Active comparator | Control will consist of audio books. Receives: Other: Audio Books |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burden of dental implant surgery
Composite outcome by summing the means of the 0-10 visual analogue scales of surgical pain, state anxiety and dissatisfaction.
Measured: Measured immediately at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start12 Oct 2018
- Primary completion11 Dec 2019
- Study completion21 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Personalized Musical InterventionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathalie Gosselin, Université de Montréal
- Investigators
- Nathalie Gosselin, PhD, Principal investigator, Université de Montréal, MUSEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099264
- Sponsor's protocol ID
- 18-004-CERC-P
- Status last verified
- Jan 2022
- First submitted
- 24 Aug 2018
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bradt J, Teague A. Music interventions for dental anxiety. Oral Dis. 2018 Apr;24(3):300-306. doi: 10.1111/odi.12615. Epub 2017 Jan 5.
PubMed 27886431Carter AE, Carter G, Boschen M, AlShwaimi E, George R. Pathways of fear and anxiety in dentistry: A review. World J Clin Cases. 2014 Nov 16;2(11):642-53. doi: 10.12998/wjcc.v2.i11.642.
PubMed 25405187Cohen SM, Fiske J, Newton JT. The impact of dental anxiety on daily living. Br Dent J. 2000 Oct 14;189(7):385-90. doi: 10.1038/sj.bdj.4800777.
PubMed 11081950Gordon 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 23746494Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
PubMed 26277246Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
PubMed 29665028Mejia-Rubalcava C, Alanis-Tavira J, Mendieta-Zeron H, Sanchez-Perez L. Changes induced by music therapy to physiologic parameters in patients with dental anxiety. Complement Ther Clin Pract. 2015 Nov;21(4):282-6. doi: 10.1016/j.ctcp.2015.10.005. Epub 2015 Oct 27.
PubMed 26573456Rainville P, Bao QVH, Chretien P. Pain-related emotions modulate experimental pain perception and autonomic responses. Pain. 2005 Dec 5;118(3):306-318. doi: 10.1016/j.pain.2005.08.022. Epub 2005 Nov 14.
PubMed 16289802Roy M, Peretz I, Rainville P. Emotional valence contributes to music-induced analgesia. Pain. 2008 Jan;134(1-2):140-7. doi: 10.1016/j.pain.2007.04.003. Epub 2007 May 25.
PubMed 17532141
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Personalized Musical Intervention on Burden of Care in Dental Implant Surgery: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04099264
- Acronym / sponsor ID
- 18-004-CERC-P
- Conditions
- Personalized Musical Intervention
- Keywords
- personalized musical intervention, experimental study, dissatisfaction, anxiety, surgical pain, burden of care, pilot randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 21 Mar 2020 (actual)
- First posted
- 23 Sep 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.
Personnalized music can decrease the burden of care.
This experimental clinical trial examines the effect of personalized musical intervention on the burden of dental implant surgery. The intervention consists of a personnalized musical intervention and the control group consists of audio books. The burden of dental implant surgery will be defined by a composite variable including surgical pain, state anxiety and dissatisfaction with dental implant surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Personalized music | Experimental | Other: Personalized musicThis arm will receive an intervention which will be personalized music. It will be provided by Music Care application (https://www.music-care.com/fr). |
| Control: Audio Books | Active comparator | Other: Audio BooksControl will consist of audio books. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- will have an adequate understanding of the French or English language both written and spoken,
- will have the physical and psychological ability to understand and complete the questionnaires used in the study,
- will consent to follow research instructions,
- will consent to follow the allocated sequence of interventions without prior notification,
- will undergo a dental implant surgery not exceeding 2 hours,
Key exclusion criteria (5 listed)
- do not have the necessary clinical criteria to receive implants.
- have an implant surgical treatment that would increase treatment time beyond 2 hours,
- have a history of neurological disorders, diagnosed with severe psychiatric disorders (e.g. schizophrenia, bipolar disorder), substance abuse
- have a major diagnosed hearing problem.
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 |
|---|---|---|
| Personalized musicPatients in the intervention group will listen to personalized music from the Musicare application | Other | Intervention group: Personalized music |
| Audio BooksPatients in the active comparator group will listen to audio books | Other | Control: Audio Books |
Primary outcome
Burden of dental implant surgery
Time frame: Measured immediately at the end of surgery
Composite outcome by summing the means of the 0-10 visual analogue scales of surgical pain, state anxiety and dissatisfaction.
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 24 Jan 2022.
- Results publication: PubMed 27886431Bradt J, Teague A. Music interventions for dental anxiety. Oral Dis. 2018 Apr;24(3):300-306. doi: 10.1111/odi.12615. Epub 2017 Jan 5.
- Results publication: PubMed 25405187Carter AE, Carter G, Boschen M, AlShwaimi E, George R. Pathways of fear and anxiety in dentistry: A review. World J Clin Cases. 2014 Nov 16;2(11):642-53. doi: 10.12998/wjcc.v2.i11.642.
- Results publication: PubMed 11081950Cohen SM, Fiske J, Newton JT. The impact of dental anxiety on daily living. Br Dent J. 2000 Oct 14;189(7):385-90. doi: 10.1038/sj.bdj.4800777.
- 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 26277246Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
- Results publication: PubMed 29665028Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
- Results publication: PubMed 26573456Mejia-Rubalcava C, Alanis-Tavira J, Mendieta-Zeron H, Sanchez-Perez L. Changes induced by music therapy to physiologic parameters in patients with dental anxiety. Complement Ther Clin Pract. 2015 Nov;21(4):282-6. doi: 10.1016/j.ctcp.2015.10.005. Epub 2015 Oct 27.
- Results publication: PubMed 16289802Rainville P, Bao QVH, Chretien P. Pain-related emotions modulate experimental pain perception and autonomic responses. Pain. 2005 Dec 5;118(3):306-318. doi: 10.1016/j.pain.2005.08.022. Epub 2005 Nov 14.
- Results publication: PubMed 17532141Roy M, Peretz I, Rainville P. Emotional valence contributes to music-induced analgesia. Pain. 2008 Jan;134(1-2):140-7. doi: 10.1016/j.pain.2007.04.003. Epub 2007 May 25.
- Individual participant dataSharing planned: No
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.
Nathalie Gosselin, PhD principal investigator
Université de Montréal, MUSEC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized music and Audio Books in people with Personalized Musical Intervention, run by Université de Montréal at 1 site in Canada.
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 6 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 24 Jan 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 Canada. 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 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?
Burden of dental implant surgery (time frame: Measured immediately at the end of surgery). 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 NCT04099264, which also lists 9 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 24 Jan 2022.