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

NCT04481893 | Completed

• 1 other identifier: 2020-A00182-37
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 3

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

Conditions

Thyroid Cancer; Thyroidectomy

Keywords

virtual reality headset; stress; hypnose

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (1)

using a virtual reality headset

EXPERIMENTAL

Behavioral: Use of a virtual reality headset

Interventions

Use of a virtual reality headset BEHAVIORAL

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)

using a virtual reality headset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (3)

Centre François Baclesse

Caen, France

Location

CHU CAEN

Caen, France

Location

Clinique Mathilde

Rouen, France

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 22, 2020
• Study Start: November 18, 2020
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)