Vitamin B12 Treatment in Singers - Assessment of Effects Exploratory Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 0-10 Visual Analog Scale (VAS) - Change
研究概览
简要总结
In this study, the investigators aim to assess if vitamin B12 treatment demonstrates a beneficial effect on voice performance. If so, they wish to examine the relationship between the vitamin B12 treatment and the study participant's general well-being.
详细描述
Through the investigators' experience, they have observed that amongst singers and voice professionals, there is a common belief that there are voice benefits from cobalamin treatment. Consequently, some singers and voice professionals tend to ask for cobalamin injections in order to enhance their vocal performance. However, there are no previous reports that illustrate the effects of vitamin B12 deficiency or treatment on voice performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 65 years old
- •An active singer who is presently singing
- •Willing and able to comply with the study requirements
- •Completed and signed an informed consent form.
排除标准
- •Known vitamin B12 deficiency
- •Active or recent vitamin B12 treatment (the subject must not receive vitamin B12 treatment for at least 4 weeks)
- •Any known bleeding disorder
- •Any known laryngeal pathology
- •Plans to start any new treatment, oral/parenteral anticoagulant, supplement, or medication during the study period
- •Scored above the highest 10 percentile of performance in all three voice evaluation questionnaires will be withdrawn from the study before the first injection (i.e., scored less than or equal to 7 in the Voice Fatigue Index (VFI), less than or equal to 6 in the Evaluation of the Ability to Sing Easily (EASE), and less than or equal to 4 in the Singing Voice Handicap Index 10 (SVHI-10))
研究组 & 干预措施
Cyanocobalamin
Vitamin B12, 1,000 mg, Once
干预措施: Cyanocobalamin (Drug)
Placebo
Normal Saline Solution (0.9% Sodium Chloride), Once
干预措施: Placebo (Drug)
结局指标
主要结局
0-10 Visual Analog Scale (VAS) - Change
时间窗: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
The scale asks, "How confident are you that your voice will do what you need it to do right now?"; 0 = Not Confident At All, 10 = Extremely Confident
Evaluation of the Ability to Sing Easily (EASE) - Change
时间窗: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
1 = Not at All, 2 = Mildly, 3 = Moderately, 4 = Extremely
Singing Voice Handicap Index-10 (SVHI-10) - Change
时间窗: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Almost Always, 4 = Always
Vocal Fold Swelling (Bastian et al., 2009) - Change
时间窗: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
Happy Birthday, Staccato, Trill; 1 = Poor, 5 = Average, 10 = Excellent
Voice Fatigue Index (VFI) - Change
时间窗: Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection
0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Almost Always, 4 = Always
次要结局
- Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) - Change(Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection)
- Patients Health Questionnaire-9 for Depression - Change(Baseline, 1 Hr Post-Injection, 3 Hrs Post-Injection, 24 Hrs Post-Injection, 72 Hrs Post-Injection, 1 Wk Post-Injection)
研究者
Michael Johns
Principal Investigator
University of Southern California