- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07749573
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
The Effect of Chewing Gum in Addition to Standard Treatment on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department: A Randomized Controlled Clinical Trial
Dizziness is a common reason for emergency department visits. Posterior canal benign paroxysmal positional vertigo (BPPV) is one of the most frequent causes of peripheral vertigo. Intravenous dimenhydrinate is among the standard treatments administered in the emergency setting; however, this and similar drug classes may cause sedation and delay central compensation.
This study tests the hypothesis that chewing gum may modulate the vestibular system via trigeminal and cervical neuromuscular pathways, thereby reducing dizziness and nausea symptoms. Patients diagnosed with posterior canal BPPV who are started on intravenous dimenhydrinate will be randomly assigned to two groups: the intervention group will chew sugar-free mint-flavored gum for 20 minutes in addition to standard treatment, while the control group will receive standard treatment only. Dizziness and nausea severity will be assessed using VAS at baseline, 20 minutes, and 60 minutes.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ankara, Tyrkiet (Türkiye)
- Ankara Ataturk Sanatorium Training and Research Hospital
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Kontakt:
- Şeref Kerem Çorbacıoğlu
- Telefonnummer: +905437656176
- E-mail: serefkeremcorbacioglu@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Aged 18-65 years
- Duration of dizziness complaint less than 24 hours
- Posterior canal BPPV diagnosis confirmed by the emergency physician via the Dix-Hallpike test
- Intravenous administration of 50 mg dimenhydrinate in 100 cc 0.9% NaCl initiated by the responsible emergency physician
- Symptomatic dizziness with VAS ≥ 4
- Alert, cooperative, and able to chew gum
- Willingness to participate and provision of written informed consent
Exclusion Criteria:
- Findings suggestive of central vertigo (vertical nystagmus, diplopia, ataxia, hemiparesis, focal neurological deficit, etc.)
- Pregnancy
- Known gum intolerance, history of allergy to gum or its excipients, temporomandibular joint dysfunction, significant tooth loss, use of dentures or removable prosthetics that would prevent chewing
- Altered level of consciousness
- Central pathology detected on investigations performed during the visit
- Hemodynamic and/or respiratory instability
- Diagnosis other than posterior canal BPPV as the cause of vertigo
- Treatment other than pharmacological therapy planned or already administered by the responsible emergency physician
- Active vomiting at the time of enrollment
- Severe dizziness with VAS ≥ 8 (excluded due to high likelihood of requiring additional treatment, risk of protocol deviation, and safety concerns regarding gum chewing)
- Patients who initially consented but subsequently wish to withdraw from the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Control Group
Patients receive only the standard treatment initiated by the responsible emergency physician: 50 mg dimenhydrinate in 100 cc 0.9% NaCl administered intravenously
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Dimenhydrinate 50 mg diluted in 100 mL of 0.9% sodium chloride administered intravenously as standard treatment for posterior canal benign paroxysmal positional vertigo in the emergency department.
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Eksperimentel: Intervention Group
In addition to standard treatment (50 mg dimenhydrinate in 100 cc 0.9% NaCl IV), patients receive sugar-free mint-flavored chewing gum simultaneously with the start of treatment and chew it under observation for 20 minutes.
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Dimenhydrinate 50 mg diluted in 100 mL of 0.9% sodium chloride administered intravenously as standard treatment for posterior canal benign paroxysmal positional vertigo in the emergency department.
Participants chew one piece of sugar-free mint-flavored chewing gum under observation for 20 minutes, starting simultaneously with standard intravenous treatment.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in dizziness Visual Analog Scale score from baseline to 20 minutes
Tidsramme: Baseline and 20 minutes after treatment initiation
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The primary outcome is the change in dizziness severity measured using a 10-cm Visual Analog Scale, ranging from 0 (no dizziness) to 10 (worst imaginable dizziness), with higher scores indicating greater dizziness severity, between baseline and 20 minutes after treatment initiation.
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Baseline and 20 minutes after treatment initiation
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Nausea Visual Analog Scale score at 20 minutes
Tidsramme: 20 minutes after treatment initiation
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Nausea severity will be assessed 20 minutes after treatment initiation using a 10-cm Visual Analog Scale, ranging from 0 (no nausea) to 10 (worst imaginable nausea), with higher scores indicating greater nausea severity.
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20 minutes after treatment initiation
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Otorhinolaryngologiske sygdomme
- Sensationsforstyrrelser
- Øresygdomme
- Labyrintsygdomme
- Vestibulære sygdomme
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Svimmelhed
- Godartet Paroxysmal Positionel Vertigo
- Svimmelhed
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Farmaceutiske præparater
- Kulbrinter
- Kulbrinter, cyklisk
- Kulbrinter, aromatisk
- Aminer
- Purinoner
- Puriner
- Benzenderivater
- Ethylaminer
- Lægemiddelkombinationer
- Benzhydrylforbindelser
- Xanthines
- Theophylline
- Diphenhydramin
- Dimenhydrinat
Andre undersøgelses-id-numre
- 2024-KAEK-24/43
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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