Virtual reality in postoperative acute pain management in thoracic surgery
Descrizione riassuntiva dello studio
We are planning an interdisciplinary exploratory feasibility study at the University Hospital Basel and are exploring the possibility of using virtual reality (VR) glasses for patients after thoracic surgical procedures. We want to find out what effect such a VR headset has on acute pain in hospitalized patients. Current studies suggest that these interventions can reduce pain perception. However, they have not yet been applied to thoracic patients.
(BASEC)
Intervento studiato
As part of this study, we use a commonly used standard VR headset, through which calming 360° videos can be viewed.
(BASEC)
Malattie studiate
Patients after surgery on the chest
(BASEC)
Patients must be over 18 years old, have consented to the study, be able to speak, understand German, and have undergone a video-assisted anatomical lung resection (that is, the surgery lasted at least 90 minutes). (BASEC)
Criteri di esclusione
Patients may not participate if they: - Have significant psychiatric, cognitive, or neurological impairments (delirium, psychoses, unstable dissociative disorders, any form of organic brain disorder, ...) - Are unable to follow the study procedures (e.g., due to language problems, visual and hearing impairments, ...) - Have chronic pain - Have morphine intolerance - Excessive alcohol consumption (men > 3 standard drinks, women > 2 standard drinks per day) - Substance abuse - Are unable or unwilling to sign an informed consent (BASEC)
Luogo dello studio
Basilea
(BASEC)
Sponsor
Universitätsspital Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Jens Eckstein
061 328 47 67
jens.eckstein@clutterusb.chUniversitätsspital Basel
(BASEC)
Informazioni generali
University Hospital, Basel, Switzerland,
+41 61 328 76 89;+41 61 328 76 89
jens.eckstein@clutterusb.ch(ICTRP)
Informazioni generali
University Hospital, Basel, Switzerland
(ICTRP)
Informazioni scientifiche
University Hospital, Basel, Switzerland,
+41 61 328 76 89;+41 61 328 76 89
jens.eckstein@clutterusb.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
16.10.2023
(BASEC)
ID di studio ICTRP
NCT06097520 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (VRThx) (BASEC)
Titolo accademico
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (VRThx) (ICTRP)
Titolo pubblico
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (ICTRP)
Malattie studiate
Postoperative Pain (ICTRP)
Intervento studiato
Other: VR Intervention (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Patients =18 years
- Written informed consent as documented by signature from the patient
- Video-assisted anatomical resection of the lung (VATS) (Surgery duration of at least
90 minutes)
- Ability to speak, understand and read German
Exclusion Criteria:
- Significant mental, cognitive or neurological impairments (Delirium, psychoses,
unstable dissociative disorders, any form of organic brain disorder, ...)
- Inability to follow the study procedures (e.g., due to language problems, visual and
hearing impairments)
- Chronic pain
- Morphine intolerance
- Excessive alcohol consumption (men > 3 standard drinks, women > 2 standard drinks
per day)
- Substance abuse
- Unable or not willing to sign informed consent (ICTRP)
non disponibile
Endpoint primari e secondari
Change in postoperative pain intensity level (ICTRP)
Opioid Consumption (ICTRP)
Data di registrazione
18.10.2023 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Joanna Timiliotis, MSc;Jens Eckstein, Prof. Dr. med.;Jens Eckstein, Prof. Dr. med., jens.eckstein@usb.ch, +41 61 328 76 89;+41 61 328 76 89, University Hospital, Basel, Switzerland, (ICTRP)
ID secondari
2023-01673, am23Eckstein (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06097520 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile