Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT07240233
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-04
First Post:
2025-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Musical Intervention for Dental Anxiety
Sponsor:
Egas Moniz - Cooperativa de Ensino Superior, CRL
Organization:
Study Overview
Official Title:
Implementation of Musical Intervention as a Non-Pharmacological Strategy for Mitigating Anxiety in Dental Procedures
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MI-DENT
Brief Summary:
The goal of this clinical trial is to learn if listening to music during dental procedures lowers anxiety in adults. The main questions it aims to answer are: does music during the procedure lower dental anxiety, and does wearing headphones without audio to reduce ambient noise also lower dental anxiety. Researchers will compare three groups to see these effects: music via headphones, headphones without audio, and standard care without headphones or music.
Participants will:
* Complete a short anxiety questionnaire before the dental procedure.
* Receive one of the three approaches during the procedure: music via headphones, headphones without audio, or no headphones/music.
* Complete a short anxiety questionnaire after the dental procedure.
Participants will:
* Complete a short anxiety questionnaire before the dental procedure.
* Receive one of the three approaches during the procedure: music via headphones, headphones without audio, or no headphones/music.
* Complete a short anxiety questionnaire after the dental procedure.
Detailed Description:
Design and setting This study is a randomized, parallel-group clinical trial conducted in a dental clinic setting, evaluating two non-pharmacological auditory strategies versus standard care for reducing state anxiety during routine dental procedures in adults. Participants are randomized in a 1:1:1 ratio to: music via headphones during the procedure; headphones worn without audio to attenuate ambient noise; or standard care with no headphones or music. State anxiety is measured immediately before and after the clinical encounter to estimate within-person change and between-group differences
Participants Adults receiving dental care at a university-affiliated clinic are approached at chairside prior to seating for eligibility screening and consent. Inclusion criteria include legal age and ability to complete self-report measures independently; key exclusions include hearing impairment or hearing aids, sedative medication use prior to the visit, cognitive impairment limiting informed consent, or refusal to consent. Recruitment occurs consecutively during routine clinical sessions to enhance generalizability to real-world practice.
Interventions
* Music via headphones: participants wear wireless, supra-aural headphones delivering a standardized playlist of classical and baroque pieces (fixed sequence, \~3-hour list; actual exposure limited to visit length). Communication needs are accommodated by temporarily removing headphones when signaled; patients are instructed to raise the left hand to request interaction or report discomfort; headphones may be removed for imaging or clinical needs.
* Headphones without audio: participants wear the same model headphones with no audio to provide passive attenuation of ambient noise; clinical communication procedures mirror the music arm.
* Standard care: no headphones or music; routine dental care proceeds per usual practice.
Equipment and hygiene Wireless supra-aural Bluetooth 5.0 headphones with padded cushions are used to maximize comfort and passive noise isolation and to avoid cable interference with dental equipment. After each session, headphones are disinfected using 70% isopropyl alcohol wipes on all skin-contact surfaces and allowed to dry before reuse, following basic device-compatible infection control practices.
Outcomes and timing State dental anxiety and general state anxiety are assessed immediately pre-procedure and post-procedure using validated self-report instruments routinely used in dental anxiety research; higher scores indicate greater anxiety, and change scores (post minus pre) are the primary comparisons across arms. Pre-procedure sociodemographic and screening items characterize the sample and capture potential confounders (for example, psychotropic use, prior psychiatric diagnosis, prior anxiety crises in dental settings).
Randomization and masking Allocation to the three arms uses simple random assignment at participant level prior to the start of the procedure; outcome assessors use standardized, self-administered questionnaires to minimize assessor influence, but masking of participants and providers is not feasible due to the nature of the interventions. Analyses will follow the intention-to-treat principle, with sensitivity analyses as needed for protocol deviations.
Data handling and analysis Data are captured into a secured database for statistical analysis using standard software; descriptive statistics summarize the sample and visit characteristics (for example, procedure type and duration). The main analysis compares anxiety change across arms using repeated-measures multivariate methods to test group, time, and group-by-time interaction effects, which can increase power by accounting for within-person correlation and simultaneous outcomes when applicable. Planned covariates include procedure category (for example, emergency care, diagnosis/planning, preventive, restorative, endodontic, surgery/extraction, orthodontics, periodontics, oral rehabilitation) and prior dental anxiety history to address clinical heterogeneity.
Participant safety and ethics Participants may pause or stop the music or withdraw from the study at any time without impact on clinical care; any discomfort related to the use of headphones triggers immediate suspension of the intervention and clinical reassessment. Headphone volume is kept at a safe listening level to mitigate auditory risk, and all adverse events are recorded and managed per clinic policy. The study protocol has obtain ethics committee approval prior to enrollment, and all participants provide written informed consent; data are pseudonymized, stored on secure, access-restricted platforms, and managed to protect privacy and confidentiality.
Participants Adults receiving dental care at a university-affiliated clinic are approached at chairside prior to seating for eligibility screening and consent. Inclusion criteria include legal age and ability to complete self-report measures independently; key exclusions include hearing impairment or hearing aids, sedative medication use prior to the visit, cognitive impairment limiting informed consent, or refusal to consent. Recruitment occurs consecutively during routine clinical sessions to enhance generalizability to real-world practice.
Interventions
* Music via headphones: participants wear wireless, supra-aural headphones delivering a standardized playlist of classical and baroque pieces (fixed sequence, \~3-hour list; actual exposure limited to visit length). Communication needs are accommodated by temporarily removing headphones when signaled; patients are instructed to raise the left hand to request interaction or report discomfort; headphones may be removed for imaging or clinical needs.
* Headphones without audio: participants wear the same model headphones with no audio to provide passive attenuation of ambient noise; clinical communication procedures mirror the music arm.
* Standard care: no headphones or music; routine dental care proceeds per usual practice.
Equipment and hygiene Wireless supra-aural Bluetooth 5.0 headphones with padded cushions are used to maximize comfort and passive noise isolation and to avoid cable interference with dental equipment. After each session, headphones are disinfected using 70% isopropyl alcohol wipes on all skin-contact surfaces and allowed to dry before reuse, following basic device-compatible infection control practices.
Outcomes and timing State dental anxiety and general state anxiety are assessed immediately pre-procedure and post-procedure using validated self-report instruments routinely used in dental anxiety research; higher scores indicate greater anxiety, and change scores (post minus pre) are the primary comparisons across arms. Pre-procedure sociodemographic and screening items characterize the sample and capture potential confounders (for example, psychotropic use, prior psychiatric diagnosis, prior anxiety crises in dental settings).
Randomization and masking Allocation to the three arms uses simple random assignment at participant level prior to the start of the procedure; outcome assessors use standardized, self-administered questionnaires to minimize assessor influence, but masking of participants and providers is not feasible due to the nature of the interventions. Analyses will follow the intention-to-treat principle, with sensitivity analyses as needed for protocol deviations.
Data handling and analysis Data are captured into a secured database for statistical analysis using standard software; descriptive statistics summarize the sample and visit characteristics (for example, procedure type and duration). The main analysis compares anxiety change across arms using repeated-measures multivariate methods to test group, time, and group-by-time interaction effects, which can increase power by accounting for within-person correlation and simultaneous outcomes when applicable. Planned covariates include procedure category (for example, emergency care, diagnosis/planning, preventive, restorative, endodontic, surgery/extraction, orthodontics, periodontics, oral rehabilitation) and prior dental anxiety history to address clinical heterogeneity.
Participant safety and ethics Participants may pause or stop the music or withdraw from the study at any time without impact on clinical care; any discomfort related to the use of headphones triggers immediate suspension of the intervention and clinical reassessment. Headphone volume is kept at a safe listening level to mitigate auditory risk, and all adverse events are recorded and managed per clinic policy. The study protocol has obtain ethics committee approval prior to enrollment, and all participants provide written informed consent; data are pseudonymized, stored on secure, access-restricted platforms, and managed to protect privacy and confidentiality.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: