Postoperative PainVRThxNCT06097520
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery
A study testing VR Intervention in people with Postoperative Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- VR Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Nov 2023to 24 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (VRThx)
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- VR Intervention
- Keywords
- thoracic surgery, Virtual reality (VR)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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
Opioid consumption will be documented in both groups
Measured: 3 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start29 Nov 2023
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- investigator-initiated, single-center, randomized controlled study
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna Timiliotis, MSc, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097520
- Sponsor's protocol ID
- 2023-01673; am23Eckstein
- Other IDs
- 2023
- Acronym
- VRThx
- Status last verified
- Mar 2025
- First submitted
- 18 Oct 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery (VRThx)
- ClinicalTrials.gov ID
- NCT06097520
- Acronym / sponsor ID
- VRThx / 2023-01673; am23Eckstein
- Conditions
- Postoperative Pain
- Keywords
- thoracic surgery, Virtual reality (VR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- investigator-initiated, single-center, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: VR InterventionPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR InterventionFor 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. | Other | Intervention group |
Primary outcome
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".
1 secondary outcome
Opioid Consumption
Time frame: 3 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Timiliotis, MSc principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Intervention in people with Postoperative Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.