Effective Interventions to Overcome Severe Gag Reflex
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Gag Reflex Severity Index (GSI) Score From Pre- to Post-Intervention
研究概览
简要总结
The purpose of this study is to evaluate the use of various techniques in alleviating gag reflex following gag reflex stimulation.
Primary aim: To compare if there is any reduction in gag reflex from each of the following interventions
- Acupuncture (CV-24)
- Tape
- Anesthetic spray Secondary aim: to compare the degree of gag reduction
详细描述
The purpose of this study is to evaluate the use of various techniques in alleviating gag reflex following gag reflex stimulation.
Primary aim: To compare if there is any reduction in gag reflex from each of the following interventions
- Acupuncture (CV-24)
- Tape
- Anesthetic spray Secondary aim: to compare the degree of gag reduction
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older (individuals below 18 years will be excluded from the study as the study procedures might not be well tolerated by them, and they are not the primary population on which these procedures are used).
- •Students, faculty, or staff of Tufts SDM
- •Subjects who score a 2 or higher on the Gagging Severity Index (GSI)7 and have a positive gag reflex response when stimulated with a cotton swab at the base of the tongue/uvula/tonsil region.
排除标准
- •Adults unable to consent (cognitively impaired adults)
- •Wards of the state
- •Pregnant women (those that are self-reported)
- •Current use of anticoagulants
- •Allergy to xylocaine
- •Those with bleeding disorders
- •Those who participated in the Calibration phase of this study
研究组 & 干预措施
Acupuncture (CV-24)
A 6C file (endodontic instrumentation file) will be placed on the patient's mentolabial fold (CV24). This file will be concealed by a small paper cup; A clean alcohol wipe will be used to clean the mentolabial area prior to placing the "acupuncture needle" (6 C-File).
干预措施: Acupuncture (Device)
Tape
A piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup
干预措施: Masking Tape (Genetic)
Anesthetic spray
Will be applied to back of the throat for 10 seconds; their chin will also be concealed from the GSI examiner using a small cup and masking tape.
干预措施: Anesthetic spray (Drug)
结局指标
主要结局
Change in Gag Reflex Severity Index (GSI) Score From Pre- to Post-Intervention
时间窗: 90 minutes per subject
Change in Gag Reflex Severity Index (GSI) Score From Baseline to Post-Intervention * Acupuncture (CV-24) * Tape * Anesthetic spray Gag reflex severity will be assessed by clinicians using the Gagging Severity Index (GSI), based on definitions set by Dickinson and Fiske. GSI will first be recorded after initial gag stimulation with a cotton swab. Following randomization to one of three interventions (acupuncture, anesthetic spray, or masking tape), GSI will be recorded again. The change in GSI score will be used to measure change in gag response.
次要结局
- Self-Reported Degree of Gag Reflex Reduction Using Visual Analog Scale (VAS)(Immediately post-intervention during single study visit)