Virtual reality in postoperative acute pain management in thoracic surgery
Zusammenfassung der Studie
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)
Untersuchte Intervention
As part of this study, we use a commonly used standard VR headset, through which calming 360° videos can be viewed.
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Basel
(BASEC)
Sponsor
Universitätsspital Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Jens Eckstein
061 328 47 67
jens.eckstein@clutterusb.chUniversitätsspital Basel
(BASEC)
Allgemeine Auskünfte
University Hospital, Basel, Switzerland,
+41 61 328 76 89;+41 61 328 76 89
jens.eckstein@clutterusb.ch(ICTRP)
Allgemeine Auskünfte
University Hospital, Basel, Switzerland
(ICTRP)
Wissenschaftliche Auskünfte
University Hospital, Basel, Switzerland,
+41 61 328 76 89;+41 61 328 76 89
jens.eckstein@clutterusb.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
16.10.2023
(BASEC)
ICTRP Studien-ID
NCT06097520 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (VRThx) (BASEC)
Wissenschaftlicher Titel
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (VRThx) (ICTRP)
Öffentlicher Titel
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (ICTRP)
Untersuchte Krankheit(en)
Postoperative Pain (ICTRP)
Untersuchte Intervention
Other: VR Intervention (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Change in postoperative pain intensity level (ICTRP)
Opioid Consumption (ICTRP)
Registrierungsdatum
18.10.2023 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
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)
Sekundäre IDs
2023-01673, am23Eckstein (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06097520 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar