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NCT Number: NCT07557550

Comparison of Two Relaxation Strategies Between Glasses, Virtual Reality Headset, and Without Relaxation Tool, in the Anxiety Preoperative of Orthopedic Adult Patients

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amiens University Hospital

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

François Joachim, MD

CONTACT

[email protected]

33+322088671

Sandrine SORIOT-THOMAS, MD

SUB_INVESTIGATOR

Sylvie LANIER, IDE

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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...)
  • 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

Treatment and study plan

HypnoVR

Device

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.

PSIO

Device

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 tool

Device

Group without relaxation tool: the patient will wait 20-minute, without benefit of sendorial tools.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Heart rate variation

    Time frame: 1 hour

    Heart rate variation measured by a pulse oximeter

  2. Variation in respiratory rate

    Time frame: over 1 minute

    Variation in respiratory rate measured over 1 minute with a stopwatch

  3. Blood pressure variation

    Time frame: 1 hour

    Blood pressure variation measured with a blood pressure monitor

  4. Variation in oxygen saturation

    Time frame: 1 hour

    Variation in oxygen saturation measured with a pulse oximeter

  5. Quantity of product used

    Time frame: 1 hour

    Quantity of product used as recorded in the electronic patient record

  6. Time spent in the recovery room

    Time frame: 1 hour

    Time spent in the recovery room recorded in the computerized patient file

  7. Level of pain

    Time frame: 1 hour

    Level of pain measured by a VAS

Study contacts

Contact information is provided by the study sponsor or research team.

François JOACHIM, MD

CONTACT

[email protected]

33+322088671

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: RELAXPREOP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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