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

NCT ID: NCT04481893

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-18
• Study Completion Date: 2025-06-06

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

using a virtual reality headset

Group Type: EXPERIMENTAL

Use of a virtual reality headset

Intervention Type: 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)

Interventions

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Francois Baclesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre François Baclesse

Caen, , France

CHU CAEN

Caen, , France

Clinique Mathilde

Rouen, , France

Countries

France

Other Identifiers

2020-A00182-37

Identifier Type: -

Identifier Source: org_study_id