Acute Pain Clinical Trials

Find Acute Pain Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Amiens University Hospital
RECRUITING
Amiens
Contact Information
Primary
François JOACHIM, MD
Joachim.francois@chu-amiens.fr
33+322088671
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2027-04
Participants
Target number of participants: 632
Treatments
Experimental: HypnoVR group
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.
Experimental: PSIO Group
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.
Sham_comparator: Group without relaxation tool
the patient will wait 20-minute, without benefit of sendorial tools.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov