Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery

NCT06097520 | Completed

• 1 other identifier: 2023-01673; am23Eckstein
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

thoracic surgery; Virtual reality (VR)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Opioid Consumption

  3 postoperative days

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Patients receive a VR headset (Pico G2 4K) for 15 minutes in the time between the 2. and 3. pain assessment and will experience non-interactive videos with different immersive scenarios of nature scenes. Nature sounds, meditation or classical music accompanying the scenarios are played through noise-cancelling headphones. Additionally, a wearable with an optical PPG- and EDA-Sensor (Empatica EmbracePlus) is put on the wrist of each participant in both groups 15 minutes before the inhalation until 15 minutes after the third pain intensity assessment, which enables the tracking of vital signs and monitoring of physiological responses. In both groups the study procedure starts with determining the pain intensity immediately before and after the 15 minutes inhalation procedure which is part of the standard of care. 15 minutes after the second assessment, the pain intensity is determined a third time in both groups.

Other: VR Intervention

Control group (standard care)

NO INTERVENTION

Patients in the control group do not receive any intervention in the time between the second and third pain assessment. Additionally, a wearable with an optical PPG- and EDA-Sensor (Empatica EmbracePlus) is put on the wrist of each participant in both groups 15 minutes before the inhalation until 15 minutes after the third pain intensity assessment, which enables the tracking of vital signs and monitoring of physiological responses. In both groups the study procedure starts with determining the pain intensity using the Numeric Rating Scale (NRS) immediately before and after the 15 minutes inhalation procedure which is part of the standard of care. 15 minutes after the second assessment, the pain intensity is determined a third time in both groups.

Interventions

VR Intervention OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Joanna Timiliotis, MSc

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: investigator-initiated, single-center, randomized controlled study

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: November 29, 2023
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

CH (1)