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

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
VR Intervention
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain focused on measuring thoracic surgery, Virtual reality (VR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group (standard care)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Opioid Consumption
Opioid consumption will be documented in both groups

Full Information

First Posted
October 18, 2023
Last Updated
October 18, 2023
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT06097520
Brief Title
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery
Acronym
VRThx
Official Title
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (VRThx)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
thoracic surgery, Virtual reality (VR)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
investigator-initiated, single-center, randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm 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.
Arm Title
Control group (standard care)
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
VR Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in postoperative pain intensity level
Description
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".
Time Frame
At first, second and third postoperative day: before the inhalation procedure, immediately after the inhalation and 15 minutes after the inhalation procedure
Secondary Outcome Measure Information:
Title
Opioid Consumption
Description
Opioid consumption will be documented in both groups
Time Frame
3 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Eckstein, Prof. Dr. med.
Phone
+41 61 328 76 89
Email
jens.eckstein@usb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna Timiliotis, MSc
Email
joanna.timiliotis@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Timiliotis, MSc
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Eckstein, Prof. Dr. med.
Phone
+41 61 328 76 89
Email
jens.eckstein@usb.ch
First Name & Middle Initial & Last Name & Degree
Joanna Timiliotis, MSc
Email
joanna.timiliotis@usb.ch
First Name & Middle Initial & Last Name & Degree
Joanna Timiliotis, MSc

12. IPD Sharing Statement

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Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery

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