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Clinical Trials/NCT06097520
NCT06097520CompletedNot Applicable

Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (VRThx)

University Hospital, Basel, Switzerland2 sites in 1 country39 target enrollmentStarted: November 29, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
39
Locations
2
Primary Endpoint
Change in postoperative pain intensity level

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in postoperative pain intensity level

Time Frame: At first, second and third postoperative day: before the inhalation procedure, immediately after the inhalation and 15 minutes after the inhalation procedure

Pain intensity will be measured using the Numeric Rating Scale (NRS). The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable".

Secondary Outcomes

  • Opioid Consumption(3 postoperative days)

Investigators

Sponsor
University Hospital, Basel, Switzerland
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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