OrthopedicSATISVIRNCT04905355
Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery
A study testing Virtual reality in people with Orthopedic, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Few studies were interested in the patient satisfaction after ambulatory surgery. Most of them showed negative results due to psychological factors. The intervention including surgery and hospitalization is still perceived as painful memory for most of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic
- 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
- 388 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 31 Aug 2026
- 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
- Participant who has an ambulatory orthopedic surgery under local regional anesthesia, planned or performed in emergency
- Participant who has been given appropriate information about the study objectives and who has given his/her express written and informed consent prior to conduct any study-related procedures.
Who cannot join
- Participant with visual deficiency or deaf
- Participant who can bear virtual reality
- Participant whose physical and / or psychological health is severely impaired, which according to the investigator may affect the participant's compliance with the study
Trial locations and contacts
1 site in 1 country.
France1 site
RGDS-Clinique Aguiléra
Biarritz, 64200
Jean-Claude PAUCHARD, MD, 33 (0)5 36 28 64 00, jc_pauchard@hotmail.com
Jean-Claude PAUCHARD, MD
About this study
Official title: Contribution of Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery
Few studies were interested in the patient satisfaction after ambulatory surgery. Most of them showed negative results due to psychological factors. The intervention including surgery and hospitalization is still perceived as painful memory for most of patients. Several improving axes have been explored to change global patient experience. One new idea could be to offer a virtual reality experience during the surgery or local regional anesthesia. Some studies showed that immersive experience can reduce the anxiety, the pain, improve the patient comfort and recovery after surgery. The virtual reality is commonly used but it has to be evaluated in terms of efficiency with a prospective study and objective outcomes to go further in the improvement of the experience and the care offer to patients.
Read the detailed description
The study is to compare the patient satisfaction between patients with virtual reality experience and patients without VR experience during the ambulatory orthopedic surgery under local regional anesthesia.
- Conditions
- Orthopedic
- Being tested
- Virtual reality
- Keywords
- Surgery, Virtual Reality, Patient satisfaction, Ambulatory
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
The VR used during the ambulatory orthopedic surgery allows immersive experience in HD-2D virtual environment. Patient can choose among movies, cartoons, entertainments offered for visualization during the surgery
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) | Active comparator | Patient with VR experience during the ambulatory orthopedic surgery Receives: Device: Virtual reality |
| NO VR | No intervention | Patient without any VR experience during the ambulatory orthopedic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction of operating room management by Net Promoter Score
Net Promoter Score (scale from 0 to 10 with 3 groups: promoters for 9-10, passive for 7-8 and detractor for below 6)
Measured: One Day after surgery
Secondary outcomes (1)
Patient satisfaction of ambulatory hospitalization by e-SATIS questionnaire
e-SATIS questionnaire : measure of hospitalization experience and patient satisfaction (the best scoring is 100 , excellent satisfaction)
Measured: One Day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Sep 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthopedicStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Model description
- Use of VR or not during the ambulatory orthopedic surgery will be attributed to patient randomly.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905355
- Sponsor's protocol ID
- 2021-A00479-32
- Acronym
- SATISVIR
- Status last verified
- Apr 2024
- First submitted
- 24 May 2021
- Last updated
- 18 Apr 2024
- 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 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT04905355
- Acronym / sponsor ID
- SATISVIR / 2021-A00479-32
- Conditions
- Orthopedic
- Keywords
- Surgery, Virtual Reality, Patient satisfaction, Ambulatory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 27 May 2021 (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.
Few studies were interested in the patient satisfaction after ambulatory surgery. Most of them showed negative results due to psychological factors. The intervention including surgery and hospitalization is still perceived as painful memory for most of patients. Several improving axes have been explored to change global patient experience. One new idea could be to offer a virtual reality experience during the surgery or local regional anesthesia. Some studies showed that immersive experience can reduce the anxiety, the pain, improve the patient comfort and recovery after surgery. The virtual reality is commonly used but it has to be evaluated in terms of efficiency with a prospective study and objective outcomes to go further in the improvement of the experience and the care offer to patients.
Detailed description
The study is to compare the patient satisfaction between patients with virtual reality experience and patients without VR experience during the ambulatory orthopedic surgery under local regional anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Use of VR or not during the ambulatory orthopedic surgery will be attributed to patient randomly.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) | Active comparator | Device: Virtual realityPatient with VR experience during the ambulatory orthopedic surgery |
| NO VR | No intervention | –Patient without any VR experience during the ambulatory orthopedic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant who has an ambulatory orthopedic surgery under local regional anesthesia, planned or performed in emergency
- Participant who has been given appropriate information about the study objectives and who has given his/her express written and informed consent prior to conduct any study-related procedures.
Key exclusion criteria (3 listed)
- Participant with visual deficiency or deaf
- Participant who can bear virtual reality
- Participant whose physical and / or psychological health is severely impaired, which according to the investigator may affect the participant's compliance with the study
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 realityThe VR used during the ambulatory orthopedic surgery allows immersive experience in HD-2D virtual environment. Patient can choose among movies, cartoons, entertainments offered for visualization during the surgery | Device | Virtual Reality (VR) |
Primary outcome
Patient satisfaction of operating room management by Net Promoter Score
Time frame: One Day after surgery
Net Promoter Score (scale from 0 to 10 with 3 groups: promoters for 9-10, passive for 7-8 and detractor for below 6)
1 secondary outcome
Patient satisfaction of ambulatory hospitalization by e-SATIS questionnaire
Time frame: One Day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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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.
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 Orthopedic, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 3 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 18 Apr 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 France. 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 Jean-Claude PAUCHARD, MD (33(0)5 36 28 64 00, jc_pauchard@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction of operating room management by Net Promoter Score (time frame: One Day after surgery). 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 Apr 2024.