SPG Block Versus Placebo to Manage Anxiety at Electronic Dance Music Festivals

REB23-0181

The goal of this clinical trial is to learn about the effect of a sphenopalatine ganglion (SPG) block in anxious patients at electronic dance music festivals. The main question is: - Is an SPG block useful in reducing anxiety, in comparison to placebo? Participants will have lidocaine-soaked cotton tip applicator placed inside each nare for 10-minutes, or have a saline-soaked cotton tip applicator placed inside each nare for 10-minutes. Researchers compare the lidocaine-soaked intervention (SPG block) with the saline-soaked intervention (placebo) to see if it reduces anxiety in patients presenting at electronic dance music festivals with anxiety.

2026-05-06

2026-05-06

2026-12-01

Not yet recruiting

Early phase I

70

Inclusion Criteria: * Festival attendees aged 18+ * A complaint of anxiety of at least 1 on a scale of 0 to 10 (11-point scale, where 0 represents "no anxiety" and 10 represents "worst anxiety imaginable"). Exclusion Criteria: * Known allergy to lidocaine (standard practice involves medical team members asking patients what allergies they have; we will not directly ask about lidocaine in order to keep participants blinded to interventions) * Inability to insert cotton tip applicator through the nares (e.g., distorted nasal anatomy, active nosebleed, obstructed nasal passages) * Inability to verbally report level of anxiety * Prior administration of an oral or intravenous anti-anxiety medication (e.g., lorazepam, midazolam) by festival medical staff since arrival at the festival (would confound treatment effect)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

2024-05-09