The Effect of Chewing Gum in Addition to Standard Treatment on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in dizziness Visual Analog Scale score from baseline to 20 minutes
研究概览
简要总结
Dizziness is a common reason for emergency department visits. Posterior canal benign paroxysmal positional vertigo (BPPV) is one of the most frequent causes of peripheral vertigo. Intravenous dimenhydrinate is among the standard treatments administered in the emergency setting; however, this and similar drug classes may cause sedation and delay central compensation.
This study tests the hypothesis that chewing gum may modulate the vestibular system via trigeminal and cervical neuromuscular pathways, thereby reducing dizziness and nausea symptoms. Patients diagnosed with posterior canal BPPV who are started on intravenous dimenhydrinate will be randomly assigned to two groups: the intervention group will chew sugar-free mint-flavored gum for 20 minutes in addition to standard treatment, while the control group will receive standard treatment only. Dizziness and nausea severity will be assessed using VAS at baseline, 20 minutes, and 60 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Aged 18-65 years
- •Duration of dizziness complaint less than 24 hours
- •Posterior canal BPPV diagnosis confirmed by the emergency physician via the Dix-Hallpike test
- •Intravenous administration of 50 mg dimenhydrinate in 100 cc 0.9% NaCl initiated by the responsible emergency physician
- •Symptomatic dizziness with VAS ≥ 4
- •Alert, cooperative, and able to chew gum
- •Willingness to participate and provision of written informed consent
排除标准
- •Findings suggestive of central vertigo (vertical nystagmus, diplopia, ataxia, hemiparesis, focal neurological deficit, etc.)
- •Pregnancy
- •Known gum intolerance, history of allergy to gum or its excipients, temporomandibular joint dysfunction, significant tooth loss, use of dentures or removable prosthetics that would prevent chewing
- •Altered level of consciousness
- •Central pathology detected on investigations performed during the visit
- •Hemodynamic and/or respiratory instability
- •Diagnosis other than posterior canal BPPV as the cause of vertigo
- •Treatment other than pharmacological therapy planned or already administered by the responsible emergency physician
- •Active vomiting at the time of enrollment
- •Severe dizziness with VAS ≥ 8 (excluded due to high likelihood of requiring additional treatment, risk of protocol deviation, and safety concerns regarding gum chewing)
- •Patients who initially consented but subsequently wish to withdraw from the study
研究组 & 干预措施
Intervention Group
In addition to standard treatment (50 mg dimenhydrinate in 100 cc 0.9% NaCl IV), patients receive sugar-free mint-flavored chewing gum simultaneously with the start of treatment and chew it under observation for 20 minutes.
干预措施: Sugar-Free Mint-Flavored Chewing Gum (Behavioral)
Control Group
Patients receive only the standard treatment initiated by the responsible emergency physician: 50 mg dimenhydrinate in 100 cc 0.9% NaCl administered intravenously
干预措施: Dimenhydrinate (Drug)
Intervention Group
In addition to standard treatment (50 mg dimenhydrinate in 100 cc 0.9% NaCl IV), patients receive sugar-free mint-flavored chewing gum simultaneously with the start of treatment and chew it under observation for 20 minutes.
干预措施: Dimenhydrinate (Drug)
结局指标
主要结局
Change in dizziness Visual Analog Scale score from baseline to 20 minutes
时间窗: Baseline and 20 minutes after treatment initiation
The primary outcome is the change in dizziness severity measured using a 10-cm Visual Analog Scale, ranging from 0 (no dizziness) to 10 (worst imaginable dizziness), with higher scores indicating greater dizziness severity, between baseline and 20 minutes after treatment initiation.
次要结局
- Nausea Visual Analog Scale score at 20 minutes(20 minutes after treatment initiation)
研究者
Şeref Kerem Çorbacıoğlu
Profesor
Ankara Ataturk Sanatorium Training and Research Hospital