Knee ArthroplastyNCT07286084
Effectiveness, Satisfaction, and Usability of Virtual Reality in the Management of Postoperative Pain in Patients Undergoing Knee Arthroplasty
A study testing VIRTUAL REALITY in people with Knee Arthroplasty, run by Universidad Francisco de Vitoria.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of using virtual reality glasses to reduce the need for rescue analgesia in patients with acute postoperative pain after knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- VIRTUAL REALITY
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 27 Dec 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults ≥18 years of age, both sexes
- Scheduled unilateral knee arthroplasty
- Adequate cognitive and functional capacity to use virtual reality
- Signed informed consent
Who cannot join
- Neurological or psychiatric disorders (history of epilepsy, seizures, psychosis, schizophrenia, claustrophobia, tremor, rigidity)
- Significant visual or hearing impairments that hinder VR use
- Physical or motor limitations preventing the use of VR headsets or maintaining the required posture
- Score ≥4 on the 4AT delirium screening tool
- Pregnancy
- Recreational drug or alcohol use
- Inability to complete the intervention protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to evaluate the effectiveness of using virtual reality glasses to reduce the need for rescue analgesia in patients with acute postoperative pain after knee arthroplasty.
The main questions it aims to answer are:
- What is the impact of virtual reality use on postoperative pain perception as measured by the Visual Analogue Scale (VAS)?
- What potential adverse effects are associated with the use of virtual reality in the postoperative context?
- What is the level of satisfaction and acceptance of virtual reality as a complementary strategy for pain management?
- How does virtual reality influence quality of life and psychosocial variables in patients with acute postoperative pain after knee arthroplasty?
Read the detailed description
A single-blind, randomized controlled trial will be conducted to compare gaming, 360° video viewing, and usual care interventions. Participants will be recruited from the prehabilitation clinic at Hospital del Sureste (Arganda del Rey), and the study will follow the CONSORT guidelines for clinical crossover and parallel trials.
Three experimental groups will be tested, with interventions performed at three different time points during hospitalization, each session lasting between 10 and 30 minutes. The gaming group will play video games, the control group will view 360° videos, and the usual care group will receive standard analgesia according to the protocol.
Outcome measures will be assessed at baseline (3 months before the intervention), during the intervention, and 1 month after the intervention.
- Conditions
- Knee Arthroplasty
- Being tested
- VIRTUAL REALITY
- Keywords
- knee arthroplasty, postoperative pain, acute pain, virtual reality
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIRTUAL REALITYDevice
Interactive VR Games: Participants use Meta Quest 3 head-mounted displays running a custom-developed VR application designed to elicit upper-limb and trunk movements. The application includes multiple structured scenarios:
- Scenario 1 (Painting): Participants perform arm movements using handheld controllers to interact with a virtual painting environment.
- Scenario 2 (Greenhouse): Participants move the arm to attract a butterfly, guide it toward a flower, and complete the assigned interaction task.
- Scenario 3 (Aquarium): Participants perform bilateral arm movements to pop virtual bubbles.
Immersive 360° Videos:Participants use Meta Quest 3 head-mounted displays to view immersive 360° relaxing videos (e.g., natural landscapes accompanied by calming background music).
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | CONVENTIONAL TREATMENT |
| EXPERIMENTAL | Experimental | VR GAMES Receives: Device: VIRTUAL REALITY |
| PLACEBO | Placebo comparator | VR VIDEOS 360º Receives: Device: VIRTUAL REALITY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (VAS)
Pain intensity is assessed using a 100-mm Visual Analogue Scale (VAS), ranging from "no pain" (0 mm, left anchor) to "worst imaginable pain" (100 mm, right anchor). Higher scores indicate greater pain intensity.
Measured: Day 0 (day of intervention): pain measured at arrival to the ward and during three shifts (morning, afternoon, next-day morning), pre- and post conventional analgesia. If VR is used, pain is also measured immediately before and after each VR session.
Secondary outcomes (7)
Sociodemographic variables
Age, weight, sex, and height recorded at enrollment
Measured: Baseline
Analgesic medication use
Analgesic administration (scheduled analgesia and rescue medication) is extracted from the hospital electronic medical record (Selene). Date and time of each dose are recorded to determine whether the intervention reduces short-term analgesic requirements.
Measured: From immediate postoperative period to 48 hours post-intervention.
Adverse events
All adverse events reported by participants or investigators are documented and classified by intensity ("mild," "moderate," "severe") and by relatedness to the intervention ("none," "unlikely," "possible," "definite")
Measured: Throughout the intervention period and up to 48 hours post-intervention.
Satisfaction, Acceptability, and Perceived Safety (SEQ)
The Suitability Evaluation Questionnaire (SEQ) assesses satisfaction, acceptability, usability, and perceived safety of the VR system. It includes 13 items rated from 1 ("not at all" or "very easy") to 5 ("very much" or "very difficult"), plus one open-ended question on discomfort
Measured: Immediately post-intervention
Health-Related Quality of Life (EQ-5D-5L)
The EQ-5D-5L assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a 5-level severity scale. Provides an individual health profile and utility index
Measured: Baseline and 1-month follow-up during outpatient visit
Anxiety and depression (Goldberg Anxiety and Depression Scale)
The Goldberg Scale screens symptoms of anxiety and depression to explore changes associated with the intervention.
Measured: Baseline and 1-month follow-up during outpatient visit
Physical Activity Level (IPAQ)
The International Physical Activity Questionnaire (IPAQ) assesses duration, frequency, and intensity of physical activity in the previous week, categorizing participants into low, moderate, or high activity levels.
Measured: Baseline and 1-month follow-up during outpatient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start27 Dec 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Collaborators
- University of Castilla-La Mancha, Hospital Universitario del Sureste
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286084
- Sponsor's protocol ID
- PI 94/25
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Satisfaction, and Usability of Virtual Reality in the Management of Postoperative Pain in Patients Undergoing Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07286084
- Acronym / sponsor ID
- PI 94/25
- Conditions
- Knee Arthroplasty
- Keywords
- knee arthroplasty, postoperative pain, acute pain, virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Collaborators
- University of Castilla-La Mancha, Hospital Universitario del Sureste
- Study start
- 27 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (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 goal of this clinical trial is to evaluate the effectiveness of using virtual reality glasses to reduce the need for rescue analgesia in patients with acute postoperative pain after knee arthroplasty.
The main questions it aims to answer are:
- What is the impact of virtual reality use on postoperative pain perception as measured by the Visual Analogue Scale (VAS)?
- What potential adverse effects are associated with the use of virtual reality in the postoperative context?
- What is the level of satisfaction and acceptance of virtual reality as a complementary strategy for pain management?
- How does virtual reality influence quality of life and psychosocial variables in patients with acute postoperative pain after knee arthroplasty?
Detailed description
A single-blind, randomized controlled trial will be conducted to compare gaming, 360° video viewing, and usual care interventions. Participants will be recruited from the prehabilitation clinic at Hospital del Sureste (Arganda del Rey), and the study will follow the CONSORT guidelines for clinical crossover and parallel trials.
Three experimental groups will be tested, with interventions performed at three different time points during hospitalization, each session lasting between 10 and 30 minutes. The gaming group will play video games, the control group will view 360° videos, and the usual care group will receive standard analgesia according to the protocol.
Outcome measures will be assessed at baseline (3 months before the intervention), during the intervention, and 1 month after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –CONVENTIONAL TREATMENT |
| EXPERIMENTAL | Experimental | Device: VIRTUAL REALITYVR GAMES |
| PLACEBO | Placebo comparator | Device: VIRTUAL REALITYVR VIDEOS 360º |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥18 years of age, both sexes
- Scheduled unilateral knee arthroplasty
- Adequate cognitive and functional capacity to use virtual reality
- Signed informed consent
Key exclusion criteria (7 listed)
- Neurological or psychiatric disorders (history of epilepsy, seizures, psychosis, schizophrenia, claustrophobia, tremor, rigidity)
- Significant visual or hearing impairments that hinder VR use
- Physical or motor limitations preventing the use of VR headsets or maintaining the required posture
- Score ≥4 on the 4AT delirium screening tool
- Pregnancy
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 REALITYInteractive VR Games: Participants use Meta Quest 3 head-mounted displays running a custom-developed VR application designed to elicit upper-limb and trunk movements. The application includes multiple structured scenarios: * Scenario 1 (Painting): Participants perform arm movements using handheld controllers to interact with a virtual painting environment. * Scenario 2 (Greenhouse): Participants move the arm to attract a butterfly, guide it toward a flower, and complete the assigned interaction task. * Scenario 3 (Aquarium): Participants perform bilateral arm movements to pop virtual bubbles. Immersive 360° Videos:Participants use Meta Quest 3 head-mounted displays to view immersive 360° relaxing videos (e.g., natural landscapes accompanied by calming background music). | Device | EXPERIMENTAL, PLACEBO |
Primary outcome
Pain intensity (VAS)
Time frame: Day 0 (day of intervention): pain measured at arrival to the ward and during three shifts (morning, afternoon, next-day morning), pre- and post conventional analgesia. If VR is used, pain is also measured immediately before and after each VR session.
Pain intensity is assessed using a 100-mm Visual Analogue Scale (VAS), ranging from "no pain" (0 mm, left anchor) to "worst imaginable pain" (100 mm, right anchor). Higher scores indicate greater pain intensity.
7 secondary outcomes
Sociodemographic variables
Time frame: Baseline
Analgesic medication use
Time frame: From immediate postoperative period to 48 hours post-intervention.
Adverse events
Time frame: Throughout the intervention period and up to 48 hours post-intervention.
Satisfaction, Acceptability, and Perceived Safety (SEQ)
Time frame: Immediately post-intervention
Health-Related Quality of Life (EQ-5D-5L)
Time frame: Baseline and 1-month follow-up during outpatient visit
Anxiety and depression (Goldberg Anxiety and Depression Scale)
Time frame: Baseline and 1-month follow-up during outpatient visit
Physical Activity Level (IPAQ)
Time frame: Baseline and 1-month follow-up during outpatient visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
Questions about this trial
What is this clinical trial studying?
A study testing VIRTUAL REALITY in people with Knee Arthroplasty, run by Universidad Francisco de Vitoria.
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: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jara María Esteban Sopeña, PhD Student (913 24 80 64 ext. 1665, jaramaria.esteban@ufv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (VAS) (time frame: Day 0 (day of intervention): pain measured at arrival to the ward and during three shifts (morning, afternoon, next-day morning), pre- and post conventional analgesia. If VR is used, pain is also measured immediately before and after each VR session.). 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 Dec 2025.