Effectiveness of various kinds of music on vital signs and dental anxiety: a randomized double-blind controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Dental anxiety levels through MDAS questionnaire
研究概览
简要总结
A total sample of 80 subjects will be selected randomly from the people attending the out patient department in a Dental institute. Subjects will be explained the entire procedure and written consent is obtained from each of them. subjects will be selected based on inclusion and exclusion criteria. The subjects will be randomized into 4 groups with systematic allocation ratio of 1:1:1:1 by a single investigator and the groups are named as Group A, B, C, D containing 20 subjects in each group. Care will be taken in order to match all the groups in all the aspects other than the intervention provided. Vital signs (Blood pressure, Heart rate, SpO2) and dental anxiety levels using modified dental anxiety scale (MDAS) will be recorded before and after the intervention for all the subjects. then analysis will be performed to know the effectiveness of various kinds of music on vital signs and dental anxiety levels by using statistical tests.
Intervention provided:
The study will be performed in a closed room, free from other noises. Subjects lay in a supine position on the dental chair and asked to close their eyes and the subjects will be exposed to the respective music through headsets for 5 minutes.
1)Group A : Classical music (Carnatic music)
2)Group B : Acoustic music (Flute acoustic)
3)Group C : Pop music (Starboy)
4)Group D : Control group ( No music)
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •First dental visit subjects attending the out patient department in a Dental institute for dental treatment Aged 25-60 years Those who are willing to participate and gives consent for the study.
排除标准
- •People who are on daily medication for any systemic diseases People with psychological conditions People with hearing impairment peoples with alcohol and smoking habit Pregnant and lactating mothers.
结局指标
主要结局
Dental anxiety levels through MDAS questionnaire
时间窗: at 2 time intervals (at baseline and at 5 mins after intervention)
次要结局
- vital signs (heart rate, blood pressure, SPO2)(at 2 time intervals (at baseline & at 5 mins after intervention))
研究者
Bandi Blessi Sravya
Sibar institute of dental sciences