Amiens University Hospital
Amiens, Picardie, 80054, France
Location status: Recruiting
Location contact
François Joachim, MD
CONTACT
33+322088671
Sandrine SORIOT-THOMAS, MD
SUB_INVESTIGATOR
Sylvie LANIER, IDE
SUB_INVESTIGATOR
NCT Number: NCT07557550
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amiens, Picardie, 80054, France
Location status: Recruiting
François Joachim, MD
CONTACT
33+322088671
Sandrine SORIOT-THOMAS, MD
SUB_INVESTIGATOR
Sylvie LANIER, IDE
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Group without relaxation tool: the patient will wait 20-minute, without benefit of sendorial tools.
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)
Time frame: 1 hour
Heart rate variation measured by a pulse oximeter
Time frame: over 1 minute
Variation in respiratory rate measured over 1 minute with a stopwatch
Time frame: 1 hour
Blood pressure variation measured with a blood pressure monitor
Time frame: 1 hour
Variation in oxygen saturation measured with a pulse oximeter
Time frame: 1 hour
Quantity of product used as recorded in the electronic patient record
Time frame: 1 hour
Time spent in the recovery room recorded in the computerized patient file
Time frame: 1 hour
Level of pain measured by a VAS
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire, Amiens
Other
Acronym: RELAXPREOP
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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