- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07660952
Effect of IE Glasses on MRI Patient Outcomes
Examining the Effect of Immersive Entertainment Glasses on Magnetic Resonance Imaging-related Patient Outcomes
Examine the effect of immersive entertainment glasses (IEG) on patients' claustrophobia-associated anxiety levels during magnetic resonance imaging (MRI).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Frank Boza, BSN, RN, VA-BC
- Telefonnummer: 786-662-0660
- E-mail: frankbo@baptisthealth.net
Undersøgelse Kontakt Backup
- Navn: Marian Ramos, MSN, RN, CBN
- Telefonnummer: 786-527-6208
- E-mail: marianr@baptisthealth.net
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult patients at least 18 years of age
- Outpatients/inpatients scheduled for an MRI with anesthesia
- Inpatients scheduled for an MRI with an IV/PO sedative
Exclusion Criteria:
- Pregnant patients
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control Group 1
Patients who receive anesthesia (general or conscious sedation) for completion of their MRI scans as ordered by the physician. |
Patient receives anesthesia as ordered by the physician. |
|
Aktiv komparator: Control Group 2
Patients who receive oral or intravenous sedation [i.e., benzodiazepines such as lorazepam (Ativan), diazepam (Valium), alprazolam (Xanax), or equivalent] for completion of their MRI scans, as ordered by the physician. |
Patient receives a sedative as ordered by the physician. |
|
Eksperimentel: Intervention Group
Patients scheduled for MRIs with anesthesia or a sedative choose to use the immersive entertainment glasses (instead of the physician-ordered anesthesia or sedative) for completion of their MRI scans. |
Use of immersive entertainment glasses during the MRI procedure. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety relief (self-report measure 2 - Visual Analog Scale for Anxiety)
Tidsramme: 15 to 120 minutes (depends on the duration of the MRI procedure)
|
Patient's anxiety will be measured using the Visual Analog Scale for Anxiety (VAS-A), a slider scale of 0 - 100 is used to self-report anxiety (0 = not anxious and 100 = extremely anxious), taken before and after the MRI procedure. |
15 to 120 minutes (depends on the duration of the MRI procedure)
|
|
Anxiety relief (physiological measure - heart rate)
Tidsramme: 15 to 120 minutes (depends on the duration of the MRI procedure)
|
Heart rate is measured before and after the MRI procedure. Increased anxiety may cause elevation of this physiological indicator. |
15 to 120 minutes (depends on the duration of the MRI procedure)
|
|
MRI completion rate
Tidsramme: Immediately after the MRI procedure.
|
MRI completed successfully = yes or no |
Immediately after the MRI procedure.
|
|
MRI Image Quality
Tidsramme: Immediately after the MRI procedure.
|
Quality of the images as noted by the radiologist on the MRI report. |
Immediately after the MRI procedure.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Natalie Bermudez, PhD, RN, EBP-C, Baptist Health | Nursing & Health Sciences Research
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
Andre undersøgelses-id-numre
- 2355080
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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