Implementation of Musical Intervention as a Non-Pharmacological Strategy for Mitigating Anxiety in Dental Procedures
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- State Anxiety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults receiving care at the university-affiliated dental clinic, legally able to consent and willing to participate voluntarily.
- •Ability to read and independently complete brief self-report questionnaires before and after the visit.
排除标准
- •Self-reported hearing impairment, current use of hearing aids, or other auditory conditions that interfere with safe headphone use or outcome validity.
- •Use of sedative medication prior to the visit for the current appointment, or acute intoxication that may alter anxiety ratings.
- •Cognitive impairment or other condition that limits capacity to provide informed consent or to complete study questionnaires reliably.
- •Unwillingness to wear headphones during the procedure if randomized to a headphone arm, or refusal to participate/withdrawal of consent at any time.
- •Any urgent clinical indication that, in the clinician's judgment, precludes headphone use (for example, need for uninterrupted verbal interaction or imaging incompatible with wearing the device).
- •Reported history of severe adverse reactions to headphone use (for example, marked discomfort, vertigo) or skin sensitivity incompatible with device contact points.
- •Inability to protect privacy or comply with basic study procedures (for example, cannot complete pre- and post-visit questionnaires within the clinic workflow)
研究组 & 干预措施
Standard care
no headphones or music; routine dental care proceeds per usual practice
Music via headphones
Participants wear wireless, supra-aural headphones delivering a standardized playlist of classical and baroque pieces
干预措施: Music via headphones (Other)
Headphones without audio
Participants wear the same model headphones with no audio to provide passive attenuation of ambient noise
干预措施: Headphones without audio (Other)
结局指标
主要结局
State Anxiety
时间窗: Participants are assessed at the beginning and at the end of each dental appointment throughout a 5-month period
State anxiety measured by the STAI Y-1 - State Anxiety Inventory
Dental anxiety
时间窗: Participants are assessed at the beginning and at the end of each dental appointment throughout a 5-month period
Dental anxiety measured by the MDAS - Modified Dental Anxiety Scale
次要结局
未报告次要终点