Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery

Postoperative Pain Clinical Trial

— VRThx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097520
• Other study ID #: 2023-01673; am23Eckstein
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Jens Eckstein, Prof. Dr. med.
• Phone: +41 61 328 76 89
• Email: jens.eckstein[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Postoperative Pain

Intervention

Other:
• VR Intervention
For the VR Intervention a VR head-mounted display, the Pico G2 4K, will be used. This intervention involves wearing VR glasses and experiencing non-interactive videos with sound through a headset. The footage consists of different immersive 360-degree scenarios from natural environments (e.g., forest), while corresponding sounds, meditation or classical music harmoniously tuned to these scenarios and are played through noise-cancelling headphones.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postoperative pain intensity level	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".	At first, second and third postoperative day: before the inhalation procedure, immediately after the inhalation and 15 minutes after the inhalation procedure
Secondary	Opioid Consumption	Opioid consumption will be documented in both groups	3 postoperative days