Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy

Study Overview
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Brief Summary
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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

Official Title
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Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy

Conditions
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Thyroid Cancer, Thyroidectomy

Intervention / Treatment
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* Behavioral: Use of a virtual reality headset


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: using a virtual reality headset<br> | Behavioral: Use of a virtual reality headset<br>* The intervention will consist of 2 sessions of 30 minutes each, based on the use of a virtual reality headset with the AQUA® application. The 1st session will take place on the day of the surgical intervention, upon arrival in hospital, after reception in the room. The 2nd session will take place the same day, post-operatively, once the awakening is satisfactory (within 3 to 6 hours after the intervention)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Anxiety state (STAI-Y scale) | 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. | Before surgery and up to 2 hours after surgery | 
| Change of Anxiety state(AE scale) | 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. | Before surgery and up to 2 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety evaluation by Amsterdam Preoperative Anxiety and Information Scale (APAIS) | Anxiety score [minimum value 0 , up to maximum value (worse) 20] according to the Amsterdam Pre-operative Anxiety and Information Scale (APAIS) | up to 1 month after surgery | 
| Pain evaluation (Visual Analog Pain Scale) | Score on the VAS pain scale [minimum value 0, up to maximum value (worse) 10] | up to 1 month after surgery | 
| Satisfaction of patients by EVAN-G scale (Evaluation of the General Anesthesia feelings) | score of EVAN-G questionnaire [minimum value 0, up to maximum value (worse) 100] | Up to 2 hours after surgery | 
| Taking of anxiolytics | variation of amount of anti-anxiety medication | up to 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality headset, stress, hypnose