Clinical trial NCT06097520: Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery
Official title: Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (VRThx)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: thoracic surgery
Virtual reality (VR)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: investigator-initiated, single-center, randomized controlled study
Primary purpose: OTHER

Brief summary: This randomized controlled study is to investigate the effectiveness of VR headsets in reducing postoperative pain intensity among patients after having undergone thoracic surgical procedures.

Detailed description: Thoracic surgical procedures can often result in postoperative pain. Traditional methods of pain management, such as medication, have limitations in terms of their efficacy and potential side effects. Therefore, there is a need for alternative approaches that can effectively alleviate postoperative pain while minimizing medication use. Virtual reality (VR) technology has gained attention as a potential non-pharmacological intervention for pain management. There is limited research specifically focusing on the use of VR in the context of thoracic surgery. This study is to investigate the effectiveness of VR headsets in reducing postoperative pain intensity among patients after having undergone thoracic surgical procedures. To enhance the objectivity of the investigation, objective parameters alongside subjective assessments of pain will be incorporated. While self-reported measures are valuable, they can be subjective and influenced by individual perception. Therefore, the subjective assessments will be complemented by objective measurements to gain a more comprehensive understanding of the pain experience and its modulation through the VR intervention.

Eligibility 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

Primary outcomes:
measure: Change in postoperative pain intensity level
timeFrame: At first, second and third postoperative day: before the inhalation procedure, immediately after the inhalation and 15 minutes after the inhalation procedure
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 3 postoperative days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Joanna Timiliotis, MSc
role: PRINCIPAL_INVESTIGATOR
References: