Pain, PostoperativePhase 2VRppainNCT03776344
Virtual Reality for Post Operative Pain
A Phase 2 study testing Virtual Reality intervention - Oculus Rift HD in people with Pain, Postoperative, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
Randomized controlled trial to measure pain experience, side effects and satisfaction of VR following varicose vein, hernia repair and gallbladder surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Virtual Reality intervention - Oculus Rift HD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteRomania
- Study dates
- 10 Oct 2018to 30 Sep 2019
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with varicose vein, hernia repair or gallbladder surgery
- Patient in the acute care units, 1-3 days following surgery.
- Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire.
Who cannot join
- Non-Romanian speaking patients.
- Age > 18 years and < 65 years.
- Patients with neoplastic pathologies.
- Patients with history of motion sickness.
- Patients with visual impairment.
- Patients with severe/profound cognitive impairments measured with Six-item Cognitive Impairment Test (6CIT).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial
Randomized controlled trial to measure pain experience, side effects and satisfaction of VR following varicose vein, hernia repair and gallbladder surgeries.
Read the detailed description
While there is substantial evidence supporting the use of Virtual Reality (VR) during dressing changes for burn victims, there are little information of the effect of VR to decrease pain after surgery. Although pharmacological analgesics are popular in clinical practice, this approach usually is associated with side effects, most commonly nausea, cognitive dysfunction, and constipation. Generally, VR effects are based on gate theory of cognitive load, due to the fact that conscious attention is needed to perceive pain and we can process a finite amount of information.High-Tech-VR devices shown to be more effective in reducing pain than are Low-Tech-VR systems (Prothero, J. D., \& Hoffman, H. D, 1995). In addition, studies have shown that interactivity play an important role to decrease both, pain unpleasantness and time spent thinking about pain, while increasing fun (Wender, R., et al., 2010, Gromala, D., et al 2011). Thus, interactivity helps patients to have a better immersion into VR world. Considering this, in the proposed study, patients will be randomized to either receive a high immersive and interactive VR environment using Oculus Rift Headset in addition to standard care or to receive only standard care during their post-operative care following surgery to prospectively assess the utility of virtual reality (VR) for pain management following varicose vein, hernia repair and gallbladder surgeries.
- Conditions
- Pain, Postoperative
- Being tested
- Virtual Reality intervention - Oculus Rift HD
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality intervention - Oculus Rift HDDevice
During the VR experience patients will have the opportunity to choose from different VR environments (VR application - Nature Treks VR) and explore them using Oculus Rift Device.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Patients randomized to the experimental group will benefit from the usual standard care following surgery and during the second day the opportunity to use virtual reality for 15 minute. Along VR, they will complete the psychological and physiological measures. Receives: Device: Virtual Reality intervention - Oculus Rift HD |
| Non-VR condition (Standard of Care) | No intervention | Patients randomized to the control group will benefit from the usual standard care following surgery and during the second day will complete the psychological and physiological measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Graphic Rating Scale measure pain intensity from 1 to 10, 1 - no pain; 10 - worst pain.
Measured: Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention)
Pain intensity
Skin conductance response
Measured: 5 minutes before intervention (baseline)
Pain intensity
Skin conductance response
Measured: 15 minutes - During the intervention
Secondary outcomes (5)
Satisfaction with the intervention
Patient Satisfaction Survey
Measured: Immediately following intervention
Presence in the VR environment
Presence Inventory assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention
Measured: Immediately following intervention
Simulator Sickness
Simulator Sickness Questionnaire
Measured: Immediately following intervention
Relaxation
Graphic Rating Scale measure relaxation from 1 to 10, 1 - stressed; 10 - very relaxed.
Measured: Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention)
Time thinking about pain
Graphic Rating Scale measure the time spent thinking about pain from 1 to 10; 1 - not at all, 10 - all the time
Measured: immediately following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start10 Oct 2018
- Primary completion31 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We tested the efficacy of a VR environment in the treatment of pain after surgery.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raluca Georgescu, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776344
- Sponsor's protocol ID
- 7150
- Acronym
- VRppain
- Status last verified
- Jan 2020
- First submitted
- 12 Dec 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data will be shared in an anonymized manner.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03776344
- Acronym / sponsor ID
- VRppain / 7150
- Conditions
- Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 14 Dec 2018 (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.
Randomized controlled trial to measure pain experience, side effects and satisfaction of VR following varicose vein, hernia repair and gallbladder surgeries.
Detailed description
While there is substantial evidence supporting the use of Virtual Reality (VR) during dressing changes for burn victims, there are little information of the effect of VR to decrease pain after surgery. Although pharmacological analgesics are popular in clinical practice, this approach usually is associated with side effects, most commonly nausea, cognitive dysfunction, and constipation. Generally, VR effects are based on gate theory of cognitive load, due to the fact that conscious attention is needed to perceive pain and we can process a finite amount of information.High-Tech-VR devices shown to be more effective in reducing pain than are Low-Tech-VR systems (Prothero, J. D., \& Hoffman, H. D, 1995). In addition, studies have shown that interactivity play an important role to decrease both, pain unpleasantness and time spent thinking about pain, while increasing fun (Wender, R., et al., 2010, Gromala, D., et al 2011). Thus, interactivity helps patients to have a better immersion into VR world. Considering this, in the proposed study, patients will be randomized to either receive a high immersive and interactive VR environment using Oculus Rift Headset in addition to standard care or to receive only standard care during their post-operative care following surgery to prospectively assess the utility of virtual reality (VR) for pain management following varicose vein, hernia repair and gallbladder surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- We tested the efficacy of a VR environment in the treatment of pain after surgery.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual Reality intervention - Oculus Rift HDPatients randomized to the experimental group will benefit from the usual standard care following surgery and during the second day the opportunity to use virtual reality for 15 minute. Along VR, they will complete the psychological and physiological measures. |
| Non-VR condition (Standard of Care) | No intervention | –Patients randomized to the control group will benefit from the usual standard care following surgery and during the second day will complete the psychological and physiological measures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with varicose vein, hernia repair or gallbladder surgery
- Patient in the acute care units, 1-3 days following surgery.
- Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire.
Key exclusion criteria (6 listed)
- Non-Romanian speaking patients.
- Age > 18 years and < 65 years.
- Patients with neoplastic pathologies.
- Patients with history of motion sickness.
- Patients with visual impairment.
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 Reality intervention - Oculus Rift HDDuring the VR experience patients will have the opportunity to choose from different VR environments (VR application - Nature Treks VR) and explore them using Oculus Rift Device. | Device | Virtual Reality |
Primary outcome
Pain intensity
Time frame: Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention)
Graphic Rating Scale measure pain intensity from 1 to 10, 1 - no pain; 10 - worst pain.
Pain intensity
Time frame: 5 minutes before intervention (baseline)
Skin conductance response
Pain intensity
Time frame: 15 minutes - During the intervention
Skin conductance response
5 secondary outcomes
Satisfaction with the intervention
Time frame: Immediately following intervention
Presence in the VR environment
Time frame: Immediately following intervention
Simulator Sickness
Time frame: Immediately following intervention
Relaxation
Time frame: Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention)
Time thinking about pain
Time frame: immediately following intervention
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 18 Jan 2020.
- Individual participant dataSharing planned: Yes. All collected data will be shared in an anonymized manner.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Virtual Reality intervention - Oculus Rift HD in people with Pain, Postoperative, run by Babes-Bolyai University at 1 site in Romania.
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 3 inclusion and 6 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 18 Jan 2020. 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 Romania. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain intensity (time frame: Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention)). The study lists 3 primary outcomes in all. 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 18 Jan 2020.