Acupuncture Mechanism in Relief of Gag Reflex
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture.
- Who it may be relevant to
- Registry conditions: Gag (Pharyngeal) Reflex. Basic parameters: 20 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Mechanism of Acupuncture for Relief of Pharyngeal (Gag) Reflex - an Experimental Crossover Investigation
Overview
The gag reflex relief effect of acupuncture of CV24 acupoint will be compared to acupuncture of PC6 and K3 acupoints in healthy volunteers in crossover mode. Second step will be the investigation whether local anesthesia using EMLA creme will block the gag relief effect of CV24 acupuncture in healthy volunteers.
Interventions
- Other Acupuncture
Needling of acupoints CV24, PC6 and K3
Primary outcome measures
- Length of saliva injector insertion (cm) [Time frame: Day 1 ( before and after acupuncture)]
Secondary outcome measures (1)
- Severity of gagging, measured using the Numeric Rating Scale NRS-11 (0=no gagging; 10=maximal) [Time frame: Day 1 ( before and after acupuncture)]
Eligibility criteria
Inclusion criteria
- Healthy volunteers aged between 20-40 years old with an American Society of Anesthesiologists physical status of I to II naïve to acupuncture
- Participants without previous opioid and psychotropic medication
- Without use of recreational drugs 3 days prior to study sessions
- Without systemic disease or local skin lesions at the sites of acupuncture
- Without drug allergy to local anesthetics, especially EMLA preparation
- Participants who have given written informed consent
Exclusion criteria
- Local skin infection at the sites of acupuncture
- Aged < 20 or > 35 years
- History of drug allergy to local anesthetics
- Participants who are unable to understand the consent form or to use numeric rating scale NRS-11
Discontinuation Criteria
- Any adverse effects during study session
- In case of local or systemic infection
- In case if subject will withdraw from participation in this study at any time, for any reason, specified or non-specified, and without penalty or loss of benefits
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Germany · 1 center
- University Medicine of Greifswald — Greifswald
Identifiers
NCT: NCT07664826 · BB150/25 · BB150/25