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

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 Overview

• Status: Completed
• Conditions: Thyroid Cancer; Thyroidectomy
• Intervention / Treatment: Behavioral: Use of a virtual reality headset

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France
    • CHU caen
  • Caen, France
    • Centre Francois Baclesse
  • Rouen, France
    • Clinique Mathilde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: using a virtual reality headset

Behavioral: Use of a virtual reality headset; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Actual): June 6, 2025
• Study Completion (Actual): June 6, 2025

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: stress; virtual reality headset; hypnose
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: 2020-A00182-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No