Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 82
- Locations
- 3
- Primary Endpoint
- Change of Anxiety state (STAI-Y scale)
Study Overview
Brief Summary
Study the interest of hypnosis techniques by virtual reality based on the use of a virtual reality headset with the AQUA® application on the reduction of pre-operative stress in patients candidates for total thyroidectomy
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient> 18 years old
- •Man or woman
- •Patient candidate for a total thyroidectomy, or a thyroid totalization
- •Preoperative Euthyroidism
- •Can justify outpatient care: score of the American Society of Anesthesiology (ASA) 1, 2 or 3 stable; accompanied for return at home; can be watched by a loved one the night after returning home; reachable by telephone; living within an hour of transportation from a hospital and having a good level of understanding.
- •No history of parathyroid or recurrent pathology
- •Signature of informed consent before any specific procedure related to the study
- •Subject affiliated with a health security system
Exclusion Criteria
- •Patient with a submerged goiter (lower edge of the thyroid not seen on the preoperative cervical ultrasound)
- •Patient with uncontrolled infectious pathology
- •Pregnant or breastfeeding woman or lack of contraception during genital activity
- •Patient with illnesses or conditions that hinder their ability to understand follow and / or comply with study procedures
- •Patient with personality disorders and / or psychiatric pathology
- •Patient deprived of liberty or placed under the authority of a guardian
Outcomes
Primary Outcomes
Change of Anxiety state (STAI-Y scale)
Time Frame: Before surgery and up to 2 hours after surgery
The proportion of patients whose pre-operative anxiety state (STAI-Y scale)is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.
Change of Anxiety state(AE scale)
Time Frame: Before surgery and up to 2 hours after surgery
The proportion of patients whose preoperative anxiety state (AE) is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.
Secondary Outcomes
- Anxiety evaluation by Amsterdam Preoperative Anxiety and Information Scale (APAIS)(up to 1 month after surgery)
- Pain evaluation (Visual Analog Pain Scale)(up to 1 month after surgery)
- Satisfaction of patients by EVAN-G scale (Evaluation of the General Anesthesia feelings)(Up to 2 hours after surgery)
- Taking of anxiolytics(up to 1 month after surgery)