Post Operative PainVRECOVERYNCT06001502
The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.
A study testing Virtual Reality distraction therapy in people with Post Operative Pain and Post Operative Anxiety, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Post Operative Anxiety, Heart Surgery
- What is being tested?
- Virtual Reality distraction therapy
- 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
- 1 Jan 2023to 1 Sep 2024
- 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
- Age ≥18 years or older with written informed consent
- Patients undergoing surgical CABG
Who cannot join
- Major comorbidities besides coronary artery disease
- Complicated surgical procedure
- Hearing and/or visual impairments
- Psychiatric impairments
- Complaints of vomiting and nausea
- History of epilepsy
Show all 10Show fewer
- Claustrophobia
- Facial wounds and skin defects at site of application
- Patients placed in clinical isolation
- Readmission to the intensive care unit
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
Sulayman El Mathari, MD, +31 205668188, s.elmathari@amsterdamumc.nl
About this study
The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.
Participants in the intervention group will receive a 20 minute session with the head mounted VR device on post-operative days 1,2 and 3.
Participants in the control group will be treated with conventional post-operative care.
Read the detailed description
Objective: The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.
Study design: This study is a single-center randomized control trial.
Study population: Patients who have undergone a CABG procedure (n=100).
Intervention: The intervention group (n=50) will use the VR distraction therapy device at day 1, 2 and 3 after surgery on the general ward. The control group (n=50) will be treated with conventional post-operative pain and anxiety management.
Main study parameters/endpoints: The main study parameters at day 1, 2 and 3 after surgery. These are the Numeric Rating Scale (NRS) to assess the effect of pain on mobility, the Quality of Recovery-15 questionnaire, the State-Trait Anxiety Inventory-6 questionnaire and assessment of analgesic use. At follow-up, participants will be called to gather one-time QoR-15 and STAI-6 questionnaire data 6 weeks after the surgery.
- Conditions
- Post Operative Pain, Post Operative Anxiety, Heart Surgery, Coronary Artery Bypass Grafting, Virtual Reality
- Being tested
- Virtual Reality distraction therapy
- 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 distraction therapyDevice
Also called Healthy Mind VR device
The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality group | Experimental | Virtual Reality distraction therapy on post-operative days 1,2 and 3. Receives: Device: Virtual Reality distraction therapy |
| Control Group | No intervention | Conventional post-operative pain and anxiety management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
The NRS score is a numeric scale in which individuals rate pain from 0 (no pain) tot 10 (worst pain). This is a subjective score which is assessed verbally and used frequently in standard clinical care in multiple medical specialties.
Measured: Post-operative days 1,2 and 3 directly after the VR intervention
State- Trait Anxiety Inventory 6 questionnaire
The STAI-6 questionnaire is a validated psychological inventory designed to measure worry, tension and anxiety in an individual. It is a shortend version of the STAI score
Measured: Post-operative days 1,2 and 3 directly after the VR intervention
Quality of Recovery-15
The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery.
Measured: Post-operative days 1,2 and 3 directly after the VR intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jan 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolanda Kluin, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jolanda Kluin, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001502
- Sponsor's protocol ID
- NL79616.018.21
- Acronym
- VRECOVERY
- Status last verified
- Jul 2024
- First submitted
- 14 Aug 2023
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request available.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT06001502
- Acronym / sponsor ID
- VRECOVERY / NL79616.018.21
- Conditions
- Post Operative Pain, Post Operative Anxiety, Heart Surgery, Coronary Artery Bypass Grafting, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 21 Aug 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.
The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.
Participants in the intervention group will receive a 20 minute session with the head mounted VR device on post-operative days 1,2 and 3.
Participants in the control group will be treated with conventional post-operative care.
Detailed description
Objective: The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.
Study design: This study is a single-center randomized control trial.
Study population: Patients who have undergone a CABG procedure (n=100).
Intervention: The intervention group (n=50) will use the VR distraction therapy device at day 1, 2 and 3 after surgery on the general ward. The control group (n=50) will be treated with conventional post-operative pain and anxiety management.
Main study parameters/endpoints: The main study parameters at day 1, 2 and 3 after surgery. These are the Numeric Rating Scale (NRS) to assess the effect of pain on mobility, the Quality of Recovery-15 questionnaire, the State-Trait Anxiety Inventory-6 questionnaire and assessment of analgesic use. At follow-up, participants will be called to gather one-time QoR-15 and STAI-6 questionnaire data 6 weeks after the surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality group | Experimental | Device: Virtual Reality distraction therapyVirtual Reality distraction therapy on post-operative days 1,2 and 3. |
| Control Group | No intervention | –Conventional post-operative pain and anxiety management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years or older with written informed consent
- Patients undergoing surgical CABG
Key exclusion criteria (10 listed)
- Major comorbidities besides coronary artery disease
- Complicated surgical procedure
- Hearing and/or visual impairments
- Psychiatric impairments
- Complaints of vomiting and nausea
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 distraction therapyAlso: Healthy Mind VR deviceThe VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings | Device | Virtual Reality group |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: Post-operative days 1,2 and 3 directly after the VR intervention
The NRS score is a numeric scale in which individuals rate pain from 0 (no pain) tot 10 (worst pain). This is a subjective score which is assessed verbally and used frequently in standard clinical care in multiple medical specialties.
State- Trait Anxiety Inventory 6 questionnaire
Time frame: Post-operative days 1,2 and 3 directly after the VR intervention
The STAI-6 questionnaire is a validated psychological inventory designed to measure worry, tension and anxiety in an individual. It is a shortend version of the STAI score
Quality of Recovery-15
Time frame: Post-operative days 1,2 and 3 directly after the VR intervention
The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: Yes. Upon request available.
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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.
Jolanda Kluin, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 distraction therapy in people with Post Operative Pain and Post Operative Anxiety, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sulayman El Mathari, MD (+31205668188, s.elmathari@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: Post-operative days 1,2 and 3 directly after the VR 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 10 Jul 2024.