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

Not Applicable

Active, not recruiting

• Conditions: Thyroidectomy; Thyroid Cancer

• Registration Number: NCT04481893
• Lead Sponsor: Centre Francois Baclesse

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-22
• Study Start: 2020-11-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change of Anxiety state (STAI-Y scale)	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)	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 Outcome Measures

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

Trial Locations

Locations (3)

Centre François Baclesse; 🇫🇷 Caen, France

CHU CAEN; 🇫🇷 Caen, France

Clinique Mathilde; 🇫🇷 Rouen, France