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

University Hospital Basel

Status: Completed

Conditions: Postoperative Pain

Treatments: Other: VR Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06097520

2023-01673 am23Eckstein;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

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.

Treatment:

Other: VR Intervention

Control group (standard care)

No Intervention group

Description:

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.