Virtual reality in postoperative acute pain management in thoracic surgery
Summary description of the study
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)
Intervention under investigation
As part of this study, we use a commonly used standard VR headset, through which calming 360° videos can be viewed.
(BASEC)
Disease under investigation
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)
Exclusion criteria
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)
Trial sites
Basel
(BASEC)
Sponsor
Universitätsspital Basel
(BASEC)
Contact
Contact Person Switzerland
Prof. Jens Eckstein
061 328 47 67
jens.eckstein@clutterusb.chUniversitätsspital Basel
(BASEC)
General Information
University Hospital, Basel, Switzerland,
+41 61 328 76 89;+41 61 328 76 89
jens.eckstein@clutterusb.ch(ICTRP)
General Information
University Hospital, Basel, Switzerland
(ICTRP)
Scientific Information
University Hospital, Basel, Switzerland,
+41 61 328 76 89;+41 61 328 76 89
jens.eckstein@clutterusb.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
16.10.2023
(BASEC)
ICTRP Trial ID
NCT06097520 (ICTRP)
Official title (approved by ethics committee)
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (VRThx) (BASEC)
Academic title
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (VRThx) (ICTRP)
Public title
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (ICTRP)
Disease under investigation
Postoperative Pain (ICTRP)
Intervention under investigation
Other: VR Intervention (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
Change in postoperative pain intensity level (ICTRP)
Opioid Consumption (ICTRP)
Registration date
18.10.2023 (ICTRP)
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
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)
Secondary trial IDs
2023-01673, am23Eckstein (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06097520 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available