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

Primary Purpose

Thyroid Cancer, Thyroidectomy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Use of a virtual reality headset
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroid Cancer focused on measuring virtual reality headset, stress, hypnose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre François BaclesseRecruiting
  • CHU CAEN
  • Clinique MathildeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

using a virtual reality headset

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)
Pain evaluation (Visual Analog Pain Scale)
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)
score of EVAN-G questionnaire [minimum value 0, up to maximum value (worse) 100]
Taking of anxiolytics
variation of amount of anti-anxiety medication

Full Information

First Posted
July 7, 2020
Last Updated
July 26, 2023
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT04481893
Brief Title
Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy
Acronym
ThyroVir
Official Title
Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Thyroidectomy
Keywords
virtual reality headset, stress, hypnose

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
using a virtual reality headset
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Use of a virtual reality headset
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change of Anxiety state (STAI-Y scale)
Description
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.
Time Frame
Before surgery and up to 2 hours after surgery
Title
Change of Anxiety state(AE scale)
Description
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.
Time Frame
Before surgery and up to 2 hours after surgery
Secondary Outcome Measure Information:
Title
Anxiety evaluation by Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Description
Anxiety score [minimum value 0 , up to maximum value (worse) 20] according to the Amsterdam Pre-operative Anxiety and Information Scale (APAIS)
Time Frame
up to 1 month after surgery
Title
Pain evaluation (Visual Analog Pain Scale)
Description
Score on the VAS pain scale [minimum value 0, up to maximum value (worse) 10]
Time Frame
up to 1 month after surgery
Title
Satisfaction of patients by EVAN-G scale (Evaluation of the General Anesthesia feelings)
Description
score of EVAN-G questionnaire [minimum value 0, up to maximum value (worse) 100]
Time Frame
Up to 2 hours after surgery
Title
Taking of anxiolytics
Description
variation of amount of anti-anxiety medication
Time Frame
up to 1 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vianney BASTIT, MD
Phone
0231455050
Email
v.bastit@baclesse.unicancer.fr
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vianney BASTIT, MD
Email
v.bastit@baclesse.unicancer.fr
Facility Name
CHU CAEN
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuela BABIN, Prof
Email
babin-e@chu-caen.fr
Facility Name
Clinique Mathilde
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas BON-MARDION, MD
Email
nicolas.bon-mardion@clinique-mathilde.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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