Effective Interventions to Overcome Severe Gag Reflex

Early Phase 1Not Yet RecruitingNCT07099131

Tufts University45 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gagging

Interventions

Anesthetic sprayDRUG

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.

AcupunctureDEVICE

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).

Masking TapeGENETIC

A piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in Gag Reflex Severity Index (GSI) Score From Pre- to Post-Intervention

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.

Time frame: 90 minutes per subject

Secondary Outcomes

Self-Reported Degree of Gag Reflex Reduction Using Visual Analog Scale (VAS)

Participants will complete an in-session survey to rate their gag reflex severity after the assigned intervention using a Visual Analog Scale (VAS). The VAS rating reflects the participant's perception of gag reduction following either acupuncture at CV24, anesthetic spray, or masking tape application.

Time frame: Immediately post-intervention during single study visit

Central Contacts

Devon Ptak

CONTACT

6176366889 devon.ptak@tufts.edu

Data from ClinicalTrials.gov

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