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

Thyroid Cancer Clinical Trial

— ThyroVir  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04481893
• Other study ID #: 2020-A00182-37
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Centre Francois Baclesse
• Contact: Vianney BASTIT, MD
• Phone: 0231455050
• Email: v.bastit[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Neoplasms
• Thyroidectomy

Intervention

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)

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	CHU CAEN	Caen
France	Clinique Mathilde	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Taking of anxiolytics	variation of amount of anti-anxiety medication	up to 1 month after surgery