RelaxationRELAXPREOPNCT07557550
Comparison of Two Relaxation Strategies Between Glasses, Virtual Reality Headset, and Without Relaxation Tool, in the Anxiety Preoperative of Orthopedic Adult Patients
A study testing HypnoVR, PSIO and no relaxation tool in people with Relaxation and Virtual Reality, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In adults, the prevalence of preoperative anxiety related to surgery or anesthesia ranges from 60 to 80%, and context plays an important role. Patients with significant preoperative anxiety experience reduced sleep quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relaxation, Virtual Reality, Anxiety Preoperative
- What is being tested?
- HypnoVR, PSIO and no relaxation tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 632 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to Apr 2027
- 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
- Patient treated at the UAC D0
- Orthopedic patient (arthroplasty mainly)
- Anesthesic procedure with general anesthesia
- Patient >18 years old without cognitive impairment in the investigator's judgment
- Patient who has signed a free and informed consent
- Patient affiliated to a social security scheme
Who cannot join
- Patient with deafness that does not allow him to perceive and understand sounds
- Patient with a visual impairment who does not allow him to watch and understand a video
- Patient who does not master the French language (spoken, written and read)
- Patient with a history of epilepsy
- Patient with a history of migraine/headache when using a virtual reality headset
- Patients with a history of dizziness triggered by images (film, video game...)
Show all 10Show fewer
- Patient with untreated dry eye disease
- Patient with psychiatric diseases and disorders not compatible with the study in the investigator's judgment
- Patient who is pregnant, parturient, or breastfeeding.
- Patient under guardianship or curatorship, under judicial protection or deprived of public law
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Amiens University Hospital
Amiens, Picardie, 80054
François Joachim, MD, 33+322088671, Joachim.francois@chu-amiens.fr
Sandrine SORIOT-THOMAS, MD
About this study
In adults, the prevalence of preoperative anxiety related to surgery or anesthesia ranges from 60 to 80%, and context plays an important role. Patients with significant preoperative anxiety experience reduced sleep quality. In addition, high preoperative anxiety is linked to more severe postoperative pain and an increased need for painkillers. In addition, it is a source of dysfunction in care. Currently, there are no recommendations regarding the prevention of preoperative anxiety. New approaches have emerged that show some benefit: music, binaural auditory stimulation and hypnosis. In the UAC J0 unit of the Amiens-Picardie University Hospital, the caregivers offer the PSiO glasses, a tool combining three techniques: light therapy, relaxation and chromotherapy. This system has obtained CE and FCC markings and seems to be more or less effective on patients admitted to the CH . A pilot study evaluating the effects of virtual reality hypnosis on patients' preoperative anxiety has shown that this technology represents a non-invasive way to reduce preoperative stress levels without side effects and without the need for additional medical or paramedical staff. This study aims to improve the patient's well-being before their operation. Depending on the randomization, he will benefit from a relaxation session with the Psio glasses or a virtual reality hypnosis session with the Hypno VR headset. Follow-up of patients will be carried out on the basis of variation in an anxiety scale, physiological criteria, the amount of anesthetic products used, the time spent in the recovery room, and the evaluation of pain.
- Conditions
- Relaxation, Virtual Reality, Anxiety Preoperative
- Being tested
- HypnoVR, PSIO, no relaxation tool
- Keywords
- relaxation, virtual reality, anxiety preoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnoVRDevice
The patient will benefit from a 20-minute virtual reality hypnosis session in the universe of his choice. The experience consists of hypnotic speech, adapted to the study population, inducing a state of relaxation (guided breathing sequences, cardiac coherence exercises, positive suggestions), an evolving 3D virtual journey and a musical atmosphere.
PSIODevice
the patient will be given a 20-minute relaxation session with the PSiO® glasses. The experience consists of a visual stage with shimmering colors and music.
no relaxation toolDevice
Group without relaxation tool: the patient will wait 20-minute, without benefit of sendorial tools.
| Study group | Role | What they receive |
|---|---|---|
| HypnoVR group | Experimental | The patient will benefit from a 20-minute virtual reality hypnosis session in the universe of his choice. The experience consists of hypnotic speech, adapted to the study population, inducing a state of relaxation (guided breathing sequences, cardiac coherence exercises, positive suggestions), an evolving 3D virtual journey and a musical atmosphere. Receives: Device: HypnoVR |
| PSIO Group | Experimental | the patient will be given a 20-minute relaxation session with the PSiO® glasses. The experience consists of a visual stage with shimmering colors and music. Receives: Device: PSIO |
| Group without relaxation tool | Sham comparator | the patient will wait 20-minute, without benefit of sendorial tools. Receives: Device: no relaxation tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in the score on the APAIS anxiety scale
Variation in the score on the APAIS scale, 6-item scale rated from 1 to 5 The anxiety score sums items 1, 2, 4 and 5 (>11 = anxious subjects) The information desire score sums items 3 and 6 (2 to 4 = refusal of information, 5 to 7 = average desire for information, >7 = eager desire for information)
Measured: 1 hour
Secondary outcomes (7)
Heart rate variation
Heart rate variation measured by a pulse oximeter
Measured: 1 hour
Variation in respiratory rate
Variation in respiratory rate measured over 1 minute with a stopwatch
Measured: over 1 minute
Blood pressure variation
Blood pressure variation measured with a blood pressure monitor
Measured: 1 hour
Variation in oxygen saturation
Variation in oxygen saturation measured with a pulse oximeter
Measured: 1 hour
Quantity of product used
Quantity of product used as recorded in the electronic patient record
Measured: 1 hour
Time spent in the recovery room
Time spent in the recovery room recorded in the computerized patient file
Measured: 1 hour
Level of pain
Level of pain measured by a VAS
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RelaxationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557550
- Sponsor's protocol ID
- PI2025_843_0184
- Acronym
- RELAXPREOP
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 29 Apr 2026
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Relaxation Strategies Between Glasses, Virtual Reality Headset, and Without Relaxation Tool, in the Anxiety Preoperative of Orthopedic Adult Patients
- ClinicalTrials.gov ID
- NCT07557550
- Acronym / sponsor ID
- RELAXPREOP / PI2025_843_0184
- Conditions
- Relaxation, Virtual Reality, Anxiety Preoperative
- Keywords
- relaxation, virtual reality, anxiety preoperative
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 29 Apr 2026 (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.
In adults, the prevalence of preoperative anxiety related to surgery or anesthesia ranges from 60 to 80%, and context plays an important role. Patients with significant preoperative anxiety experience reduced sleep quality. In addition, high preoperative anxiety is linked to more severe postoperative pain and an increased need for painkillers. In addition, it is a source of dysfunction in care. Currently, there are no recommendations regarding the prevention of preoperative anxiety. New approaches have emerged that show some benefit: music, binaural auditory stimulation and hypnosis. In the UAC J0 unit of the Amiens-Picardie University Hospital, the caregivers offer the PSiO glasses, a tool combining three techniques: light therapy, relaxation and chromotherapy. This system has obtained CE and FCC markings and seems to be more or less effective on patients admitted to the CH . A pilot study evaluating the effects of virtual reality hypnosis on patients' preoperative anxiety has shown that this technology represents a non-invasive way to reduce preoperative stress levels without side effects and without the need for additional medical or paramedical staff. This study aims to improve the patient's well-being before their operation. Depending on the randomization, he will benefit from a relaxation session with the Psio glasses or a virtual reality hypnosis session with the Hypno VR headset. Follow-up of patients will be carried out on the basis of variation in an anxiety scale, physiological criteria, the amount of anesthetic products used, the time spent in the recovery room, and the evaluation of pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HypnoVR group | Experimental | Device: HypnoVRThe patient will benefit from a 20-minute virtual reality hypnosis session in the universe of his choice. The experience consists of hypnotic speech, adapted to the study population, inducing a state of relaxation (guided breathing sequences, cardiac coherence exercises, positive suggestions), an evolving 3D virtual journey and a musical atmosphere. |
| PSIO Group | Experimental | Device: PSIOthe patient will be given a 20-minute relaxation session with the PSiO® glasses. The experience consists of a visual stage with shimmering colors and music. |
| Group without relaxation tool | Sham comparator | Device: no relaxation toolthe patient will wait 20-minute, without benefit of sendorial tools. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient treated at the UAC D0
- Orthopedic patient (arthroplasty mainly)
- Anesthesic procedure with general anesthesia
- Patient >18 years old without cognitive impairment in the investigator's judgment
- Patient who has signed a free and informed consent
Key exclusion criteria (10 listed)
- Patient with deafness that does not allow him to perceive and understand sounds
- Patient with a visual impairment who does not allow him to watch and understand a video
- Patient who does not master the French language (spoken, written and read)
- Patient with a history of epilepsy
- Patient with a history of migraine/headache when using a virtual reality headset
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 |
|---|---|---|
| HypnoVRThe patient will benefit from a 20-minute virtual reality hypnosis session in the universe of his choice. The experience consists of hypnotic speech, adapted to the study population, inducing a state of relaxation (guided breathing sequences, cardiac coherence exercises, positive suggestions), an evolving 3D virtual journey and a musical atmosphere. | Device | HypnoVR group |
| PSIOthe patient will be given a 20-minute relaxation session with the PSiO® glasses. The experience consists of a visual stage with shimmering colors and music. | Device | PSIO Group |
| no relaxation toolGroup without relaxation tool: the patient will wait 20-minute, without benefit of sendorial tools. | Device | Group without relaxation tool |
Primary outcome
Variation in the score on the APAIS anxiety scale
Time frame: 1 hour
Variation in the score on the APAIS scale, 6-item scale rated from 1 to 5 The anxiety score sums items 1, 2, 4 and 5 (>11 = anxious subjects) The information desire score sums items 3 and 6 (2 to 4 = refusal of information, 5 to 7 = average desire for information, >7 = eager desire for information)
7 secondary outcomes
Heart rate variation
Time frame: 1 hour
Variation in respiratory rate
Time frame: over 1 minute
Blood pressure variation
Time frame: 1 hour
Variation in oxygen saturation
Time frame: 1 hour
Quantity of product used
Time frame: 1 hour
Time spent in the recovery room
Time frame: 1 hour
Level of pain
Time frame: 1 hour
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 29 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HypnoVR, PSIO and no relaxation tool in people with Relaxation and Virtual Reality, run by Centre Hospitalier Universitaire, Amiens 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 6 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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. 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 François JOACHIM, MD (33+322088671, Joachim.francois@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in the score on the APAIS anxiety scale (time frame: 1 hour). 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 29 Apr 2026.