PainVIRTUALNCT03933124
The Effect of Virtual Reality on Post-surgical Pain and Recovery.
A study testing Virtual Reality in people with Pain and Post-surgical Pain, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This study evaluates the effect of Virtual Reality (VR) on pain and recovery in 100 post-operative patients. 60 patients will be included in the intervention group; they will use VR minimal 3 times a day on day 2-4 after surgery, on the surgical ward, as an add-on intervention next to standard care. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pain, Post-surgical Pain, Pain Management
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 May 2019to 11 Feb 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient underwent surgery
- Patient reports a postoperative pain score ≥4 on the first postoperative day at the surgical ward and pain score should also be marked with 'pain is not acceptable'.
- At the day of recruitment, the estimated length of stay is at least 4 days after inclusion.
- Patient is willing and able to comply with the trial protocol.
- Patient is at least 16 years old on the day the informed consent form will be signed.
Who cannot join
- Patient suffers from delirium or acute confusional state.
- Patient has (a history of) dementia, seizure or epilepsy.
- Patient with severe hearing/visual impairment not corrected.
- Patient is placed in isolation.
- The skin of the patient's head or face is not intact (for example head wounds, psoriasis, eczema).
- Unplanned (re)admission to the intensive care unit (ICU).
- Inclusion in another trial to evaluate new ways of treating pain
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effect of Virtual Reality (VR) on pain and recovery in 100 post-operative patients. 60 patients will be included in the intervention group; they will use VR minimal 3 times a day on day 2-4 after surgery, on the surgical ward, as an add-on intervention next to standard care. 40 patients in the control group will only receive standard postoperative care.
Read the detailed description
Adequate management of post-surgical pain (PSP) may contribute to improved clinical and socioeconomic outcomes. Facilitating an adequate level of PSP relief is a challenging problem: the analgesics that are most frequently used, for example, opioids and non-steroidal anti-inflammatory drugs (NSAIDs), often come with side effects and do not always provide sufficient pain relief. Therefore, pain management is increasingly focusing on (additional) non-pharmacological analgesics, including Virtual Reality (VR).
VR immerses the user in a virtual world through a head mounted device (HMD). VR is, among other things, taught to be effective through distraction: it diverts attention away from the nociceptive input, resulting in less available attention for pain perception. In both clinical and experimental studies, VR has shown to be effective in reducing pain, anxiety and stress.
Although this distraction method is increasingly studied in the past years, VR pain relief has mostly been investigated as an intervention during painful procedures in specific research populations. For example, VR has been studied during wound dressing changes in burn wound patients in children and adolescents, during venipuncture in children or during dental treatments. Furthermore, most VR studies used VR as a single intervention, measuring pre-post differences in pain scores or used a cross over design with one VR session and one control session. It is interesting to know whether VR is effective in reducing postoperative pain during more than one VR session. More research is needed in larger trials evaluating a broad sample of the general population including elderly, as the common hospitalized patient is of an older age nowadays. Finally, it is important to evaluate the feasibility and acceptability of VR in postoperative patients and to know whether there are predictive factors to select patients who can mostly benefit from VR interventions.
- Conditions
- Pain, Post-surgical Pain, Pain Management
- Being tested
- Virtual Reality
- Keywords
- Post-surgical pain, Virtual Reality, Distraction
- Medical subject headings
- Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called Relaxmaker, Oculus Go, CareVRx
The Virtual Reality intervention is used for 10 minutes minimal 3 times a day on postoperative day 2-4.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Intervention group | Experimental | The intervention group includes 60 patients who will use Virtual Reality for postoperative pain. Participants will use Virtual Reality minimal 10 minutes, minimal 3 times a day on the second, third and fourth day after surgery, on the general ward.
* 20 participants will receive an Oculus Go immersive 3D nature videos, games, meditation videos, google earth experiences and sports games.
* 20 participants will receive a Relaxmaker with 2D nature videos
* 20 participants will receive CareVRx with 3D nature videos and meditation videos. Receives: Device: Virtual Reality |
| Control group | No intervention | The control group receives standard postoperative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Daily pain score (VAS, visual analogue scale)
Pain on average in the last 24h. VAS (visual analogue scale): 0-100 mm, 0 is defined as "no pain at all", 100 is "the worst pain the patient can imagine".
Measured: day 1-4, the first four postoperative days on the surgical ward
Secondary outcomes (15)
Time to 30% pain reduction compared to pain scores on postoperative day 1.
Time to 30% pain reduction compared to pain scores on postoperative day 1.
Measured: day 1-4, the first four postoperative days on the surgical ward.
Mean Daily worst pain score (VAS)
Worst pain in the last 24h.
Measured: day 1-4, the first four postoperative days on the surgical ward.
Effect of pain on mobility (NRS, Numeric Rating Scale)
NRS score (Numeric Rating Scale): 0-10. 0 is defined as "no pain at all", 10 is "the worst pain the patient can imagine".
Measured: day 1-4, the first four postoperative days on the surgical ward.
Difference in pain scores pre- and post- VR intervention (VAS)
Pain pre- and postintervention in the VR intervention group.
Measured: Day 2-4 on the surgical ward.
Quality of recovery -15 questionnaire.
Quality of recovery -15 questionnaire.
Measured: day 1-4, the first four postoperative days on the surgical ward.
Mean Daily Anxiety score (VAS).
Anxiety on average in the last 24h.
Measured: day 1-4, the first four postoperative days on the surgical ward.
Mean Daily Stress score (VAS)
Stress on average in the last 24h.
Measured: day 1-4, the first four postoperative days on the surgical ward.
State-Trait Anxiety Inventory (STAI)-6 questionnaire.
State-Trait Anxiety Inventory (STAI)-6 questionnaire.
Measured: day 1-4, the first four postoperative days on the surgical ward.
Difference in anxiety scores pre- and post- VR intervention. (VAS)
Anxiety pre- and postintervention in the VR intervention group.
Measured: Day 2-4 on the surgical ward.
Difference in stress scores pre- and post- VR intervention. (VAS)
Stress pre- and postintervention in the VR intervention group.
Measured: Day 2-4 on the surgical ward.
Difference in depression scores pre- and post- VR intervention. (VAS)
Depression pre- and postintervention in the VR intervention group.
Measured: Day 2-4 on the surgical ward.
Analgesic use
Analgesic use (paracetamol, NSAIDs, opioids, use of add-on/escape medication, daily defined dose of opioid, days to removal of epidural analgesia or PCA (patient-controlled intravenous analgesia, morphine IV), days to converting from opioids to NSAIDs or paracetamol without opioids).
Measured: day 1-4, the first four postoperative days on the surgical ward.
Feasibility of VR
Questionnaire, interview
Measured: Day 1-4 postoperative
Patients acceptability
Questionnaire, interview
Measured: Day 1-4 postoperative
Tolerability of Virtual Reality
Questionnaire, interview
Measured: Day 1-4 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start21 May 2019
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An explorative study using a randomized controlled parallel design.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry van Goor, MD,PhD,FRCS, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933124
- Sponsor's protocol ID
- NL69077.091.19
- Acronym
- VIRTUAL
- Status last verified
- Oct 2020
- First submitted
- 29 Apr 2019
- Last updated
- 16 Sep 2021
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Post-surgical Pain and Recovery.
- ClinicalTrials.gov ID
- NCT03933124
- Acronym / sponsor ID
- VIRTUAL / NL69077.091.19
- Conditions
- Pain, Post-surgical Pain, Pain Management
- Keywords
- Post-surgical pain, Virtual Reality, Distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 1 May 2019 (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 study evaluates the effect of Virtual Reality (VR) on pain and recovery in 100 post-operative patients. 60 patients will be included in the intervention group; they will use VR minimal 3 times a day on day 2-4 after surgery, on the surgical ward, as an add-on intervention next to standard care. 40 patients in the control group will only receive standard postoperative care.
Detailed description
Adequate management of post-surgical pain (PSP) may contribute to improved clinical and socioeconomic outcomes. Facilitating an adequate level of PSP relief is a challenging problem: the analgesics that are most frequently used, for example, opioids and non-steroidal anti-inflammatory drugs (NSAIDs), often come with side effects and do not always provide sufficient pain relief. Therefore, pain management is increasingly focusing on (additional) non-pharmacological analgesics, including Virtual Reality (VR).
VR immerses the user in a virtual world through a head mounted device (HMD). VR is, among other things, taught to be effective through distraction: it diverts attention away from the nociceptive input, resulting in less available attention for pain perception. In both clinical and experimental studies, VR has shown to be effective in reducing pain, anxiety and stress.
Although this distraction method is increasingly studied in the past years, VR pain relief has mostly been investigated as an intervention during painful procedures in specific research populations. For example, VR has been studied during wound dressing changes in burn wound patients in children and adolescents, during venipuncture in children or during dental treatments. Furthermore, most VR studies used VR as a single intervention, measuring pre-post differences in pain scores or used a cross over design with one VR session and one control session. It is interesting to know whether VR is effective in reducing postoperative pain during more than one VR session. More research is needed in larger trials evaluating a broad sample of the general population including elderly, as the common hospitalized patient is of an older age nowadays. Finally, it is important to evaluate the feasibility and acceptability of VR in postoperative patients and to know whether there are predictive factors to select patients who can mostly benefit from VR interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An explorative study using a randomized controlled parallel design.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Intervention group | Experimental | Device: Virtual RealityThe intervention group includes 60 patients who will use Virtual Reality for postoperative pain. Participants will use Virtual Reality minimal 10 minutes, minimal 3 times a day on the second, third and fourth day after surgery, on the general ward. * 20 participants will receive an Oculus Go immersive 3D nature videos, games, meditation videos, google earth experiences and sports games. * 20 participants will receive a Relaxmaker with 2D nature videos * 20 participants will receive CareVRx with 3D nature videos and meditation videos. |
| Control group | No intervention | –The control group receives standard postoperative care. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient underwent surgery
- Patient reports a postoperative pain score ≥4 on the first postoperative day at the surgical ward and pain score should also be marked with 'pain is not acceptable'.
- At the day of recruitment, the estimated length of stay is at least 4 days after inclusion.
- Patient is willing and able to comply with the trial protocol.
- Patient is at least 16 years old on the day the informed consent form will be signed.
Key exclusion criteria (7 listed)
- Patient suffers from delirium or acute confusional state.
- Patient has (a history of) dementia, seizure or epilepsy.
- Patient with severe hearing/visual impairment not corrected.
- Patient is placed in isolation.
- The skin of the patient's head or face is not intact (for example head wounds, psoriasis, eczema).
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 |
|---|---|---|
| Virtual RealityAlso: Relaxmaker, Oculus Go, CareVRxThe Virtual Reality intervention is used for 10 minutes minimal 3 times a day on postoperative day 2-4. | Device | Virtual Reality Intervention group |
Primary outcome
Mean Daily pain score (VAS, visual analogue scale)
Time frame: day 1-4, the first four postoperative days on the surgical ward
Pain on average in the last 24h. VAS (visual analogue scale): 0-100 mm, 0 is defined as "no pain at all", 100 is "the worst pain the patient can imagine".
15 secondary outcomes
Time to 30% pain reduction compared to pain scores on postoperative day 1.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Mean Daily worst pain score (VAS)
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Effect of pain on mobility (NRS, Numeric Rating Scale)
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Difference in pain scores pre- and post- VR intervention (VAS)
Time frame: Day 2-4 on the surgical ward.
Quality of recovery -15 questionnaire.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Mean Daily Anxiety score (VAS).
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Mean Daily Stress score (VAS)
Time frame: day 1-4, the first four postoperative days on the surgical ward.
State-Trait Anxiety Inventory (STAI)-6 questionnaire.
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Difference in anxiety scores pre- and post- VR intervention. (VAS)
Time frame: Day 2-4 on the surgical ward.
Difference in stress scores pre- and post- VR intervention. (VAS)
Time frame: Day 2-4 on the surgical ward.
Difference in depression scores pre- and post- VR intervention. (VAS)
Time frame: Day 2-4 on the surgical ward.
Analgesic use
Time frame: day 1-4, the first four postoperative days on the surgical ward.
Feasibility of VR
Time frame: Day 1-4 postoperative
Patients acceptability
Time frame: Day 1-4 postoperative
Tolerability of Virtual Reality
Time frame: Day 1-4 postoperative
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 16 Sep 2021.
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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.
Harry van Goor, MD,PhD,FRCS principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Pain and Post-surgical Pain, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 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 16 Sep 2021. 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 Netherlands. 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?
Mean Daily pain score (VAS, visual analogue scale) (time frame: day 1-4, the first four postoperative days on the surgical ward). 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 16 Sep 2021.