- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05069987
Anxiety Reduction in TAVI Using Virtual Reality Trial (ART-VR)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Virtual reality (VR) allows patients to be fully immerged in an engaging, interactive 3D environment. Its applications are broad and include treatment of phobias, stress-disorders, pain reduction. Recently, VR has been adopted in various medical procedures to reduce pre- and per-procedural anxiety. In TAVR, per-procedural VR immersion could potentially reduce patient anxiety leading to increased overall patient satisfaction. However, contemporary large scale, randomized evidence on VR application in TAVR is lacking.
The objective of this trial is to evaluate the effect of an immersive VR environment on procedural anxiety in patients undergoing TAVR under local anaesthesia in a randomized controlled setting. A total of 150 patients with severe aortic stenosis (AS) who undergo transfemoral TAVR under local aneasthesia will be included. The main study endpoint is procedural anxiety assessed on a visual analogue scale (VAS) directly post-procedure.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Zuid Holland
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Rotterdam, Zuid Holland, Holland, 3015 GD
- Rekruttering
- Erasmus University Medical Center
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Kontakt:
- Nicolas Van Mieghem
- E-mail: n.vanmieghem@erasmusmc.nl
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years
- Symptomatic severe aortic stenosis
- Indication for transfemoral TAVI under local anaesthesia per local heart team consensus
- Patient is able to understand and sign written informed consent
- Patient speaks Dutch, German or English
Exclusion Criteria:
- Need for emergent TAVI
- Need for planned concomitant cardiac intervention during index procedure
- History of TAVI under local anesthesia/conscious sedation
- Chronic use of benzodiapines, opioids, pregabalin or antidepressants
- History of opioid use (within 8-30 days prior to randomization)
- Claustrophobia
- Any psychiatric illness diagnosed by a psychiatrist or psychologist
- Blindness or severe visual impairment despite visual aid (glasses, contact lenses)
- Epilepsy
- Extensive cognitive impairment (MMSE <21 or as diagnosed by geriatrician)
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 |
---|---|
Eksperimentel: VR-immersion
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An immersive virtual reality experience will be generated by a head mounted device which shows the user pre-recorded videos (SynVR Relax & Distract, SyncVR Medical BV, Utrecht, The Netherlands).
These videos are recorded in 360 degree views and matched with the users' viewing direction by the head mounted device matches.
The user will not be able to see its in vivo surroundings (i.e. the Cathlab) and will be focused on the digital content.
The VR immersion will be put into place throughout the entire TAVR procedure starting before femoral access obtainment and ending after access closure.
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Ingen indgriben: Non-VR control
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Procedural Anxiety
Tidsramme: Immediately after the TAVR procedure
|
Procedural anxiety assessed on a visual analogue scale directly post-procedure.
Range: 0 (no anxiety) to 10 (worst anxiety).
|
Immediately after the TAVR procedure
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change of Anxiety
Tidsramme: 1 day (From directly before the TAVR procedure until directly after the TAVR procedure)
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Difference between pre-procedural and post-procedural anxiety visual analogue scale scores
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1 day (From directly before the TAVR procedure until directly after the TAVR procedure)
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Procedural Pain
Tidsramme: Immediately after the TAVR procedure
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Procedural pain assessed on a visual analogue scale directly post-procedure.
Range: 0 (no pain) to 10 (worst pain).
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Immediately after the TAVR procedure
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Procedural Use of Sedatives
Tidsramme: Up to 1 day (Depending on procedure duration)
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Procedural sedative use and dosage.
Amount of benzodiazepine used in milligrams
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Up to 1 day (Depending on procedure duration)
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Procedural Use of Analgesics
Tidsramme: Up to 1 day (Depending on procedure duration)
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Procedural analgesic use and dosage.
Amount of Lidocaine (or equivalent) used in milligrams
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Up to 1 day (Depending on procedure duration)
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Patient Procedural Satisfaction
Tidsramme: One day post procedure
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Procedural satisfaction assessed after 24hrs using for procedures under regional anaesthesia.
Score assessed on a visual analogue scale.
Range: 0 (not at all satisfied) to 10 (very satisfied).
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One day post procedure
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Patient reported procedural Nausea and Vomiting
Tidsramme: Up to 1 day (Depending on procedure duration)
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Patient reported nausea and vomiting during the procedure (yes/no)
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Up to 1 day (Depending on procedure duration)
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Admission time
Tidsramme: Up to 7 days
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Time leaving cathlab until discharge
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Up to 7 days
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Andre undersøgelses-id-numre
- MEC-2021-0417
- NL77298.078.21 (Anden identifikator: Central Commissie Mensgebonden Onderzoek)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
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