Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-31 @ 3:36 AM
Study NCT ID:
NCT05729503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of SPG Block for Patients With Anxiety at Electronic Dance Music Festivals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2023-02-06', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' self-reported anxiety scores post-intervention", 'timeFrame': '10-minutes post-intervention', 'description': 'Patients will rate their anxiety on an 11-point scale (0 = "no anxiety", 10 = "worst anxiety imaginable"). The lowest score is 0 and the highest score is 10. Lower scores indicate better outcome.'}], 'secondaryOutcomes': [{'measure': 'Use of rescue-medication (i.e., oral/intravenous anti-anxiety medication)', 'timeFrame': '10-minutes post-intervention', 'description': "Presence (1) or absence (0) of any rescue-medication, (i.e. oral/intravenous anti-anxiety medication), identified by patient's chart"}, {'measure': 'Improvement of headache', 'timeFrame': '10-minutes post-intervention', 'description': 'Yes, No, or N/A. For patients who had a headache prior to the intervention, these patients will answer whether the intervention improved their headache. This is because it is known that SPG blocks improve headaches. There is a possibility that anxiety may be improved, because a headache is improved.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': '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:\n\n\\- Is an SPG block useful in reducing anxiety, in comparison to placebo?\n\nParticipants 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.\n\nResearchers 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.', 'detailedDescription': '1. Background \\& Rationale\n\n Electronic dance music festivals are a growing source of entertainment in Canada. Attended by thousands at a time, it is important to have a medical team onsite to manage clinical issues in these mass gatherings. One of the most common clinical presentations at these festivals is anxiety. In a low-resource setting, it is not always possible to supply all guests with oral or injectable anti-anxiety therapy. Additionally, anti-anxiety medication is often sedating, which we would want to avoid in a patient population at higher risk of sedation (e.g., intoxication). A simple, non-sedating, alternative treatment that can be administered by a medical team member that can be given without the need of a needle would be ideal.\n\n Anecdotal reports have noted that sphenopalatine ganglion (SPG) blocks with lidocaine, intranasally, is effective for the relief of anxiety. As well, the PI has had anecdotal success in managing patient anxiety with SPG blocks. At the time of writing, there has been no published study found by our team to evaluate the efficacy of SPG blocks on anxiety.\n2. Research Question \\& Objectives\n\n Question: In electronic dance music festival attendees, who present with anxiety to the medical team, how does a 2% lidocaine-soaked cotton tip applicator, inserted into both nares until it meets resistance, compare with a saline-soaked cotton tip applicator, inserted into both nares until it meets resistance, for self-reported anxiety 10-minutes post-intervention?\n\n The objective of this trial is to study the effectiveness of bilateral SPG block for anxiety.\n3. Methods\n\nAll individuals, who present with anxiety to the main medical area at electronic dance music festivals in Canada, will be recruited until sample size reaches at least 70 people. Inclusion criteria will include festival attendees aged 18+ with a complaint of anxiety. Exclusion criteria will include known allergy to lidocaine (standard practice involves medical team members asking patients what allergies they have), inability to pass a cotton tip applicator through the nares (e.g., obstruction), inability to report level of anxiety, or already have taken an anti-anxiety medication (e.g., lorazepam, midazolam).\n\nAfter obtaining consent, participants will be randomized into two study arms using a random number generator. Arm 1 will receive an intranasal SPG block with 2% lidocaine in each nare, applied with long cotton tip applicators. Arm 2 will receive a long cotton tip applicator soaked with saline, inserted in each nare (placebo). The cotton tip applicators will remain in the nares for 10 minutes before removal.\n\nAfter randomization, participants will be asked to rate their anxiety on a numeric response scale (0 to 10, where 0 is no anxiety and 10 is "worst anxiety imaginable") prior to receiving their assigned intervention. 10-minutes following intervention, participants will be asked to rate their anxiety once more.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Festival attendees aged 18+\n* 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").\n\nExclusion Criteria:\n\n* 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)\n* Inability to insert cotton tip applicator through the nares (e.g., distorted nasal anatomy, active nosebleed, obstructed nasal passages)\n* Inability to verbally report level of anxiety\n* 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)'}, 'identificationModule': {'nctId': 'NCT05729503', 'briefTitle': 'Effect of SPG Block for Patients With Anxiety at Electronic Dance Music Festivals', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'SPG Block Versus Placebo to Manage Anxiety at Electronic Dance Music Festivals', 'orgStudyIdInfo': {'id': 'REB23-0181'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2% Lidocaine', 'description': '1 cotton tip applicator, pre-soaked in 2% lidocaine, inserted into each nare, and left for 10 minutes', 'interventionNames': ['Drug: Lidocaine 2% Injectable Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 cotton tip applicator, pre-soaked in saline, inserted into each nare, and left for 10 minutes', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine 2% Injectable Solution', 'type': 'DRUG', 'otherNames': ['Lidocaine'], 'description': 'Cotton tip applicator pre-soaked with lidocaine', 'armGroupLabels': ['2% Lidocaine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Cotton tip applicator pre-soaked with saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'country': 'Canada', 'contacts': [{'name': 'Anthony Seto', 'role': 'CONTACT'}], 'facility': 'Electronic Dance Music festivals in Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'country': 'Canada', 'contacts': [{'name': 'Anthony Seto', 'role': 'CONTACT'}], 'facility': 'Electronic Dance Music festivals in Edmonton', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Toronto', 'country': 'Canada', 'contacts': [{'name': 'Anthony Seto', 'role': 'CONTACT'}], 'facility': 'Electronic Dance Music festivals in Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Vancouver', 'country': 'Canada', 'contacts': [{'name': 'Anthony Seto', 'role': 'CONTACT'}], 'facility': 'Electronic Dance Music festivals in Vancouver', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Anthony V Seto, MD', 'role': 'CONTACT', 'email': 'avseto@gmail.com', 'phone': '1-403-681-6788'}], 'overallOfficials': [{'name': 'Anthony V Seto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}