Thyroid CancerThyroVirNCT04481893
Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy
A study testing Use of a virtual reality headset in people with Thyroid Cancer and Thyroidectomy, run by Centre Francois Baclesse at 3 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Thyroidectomy
- What is being tested?
- Use of a virtual reality headset
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesFrance
- Study dates
- 18 Nov 2020to 6 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre François Baclesse
Caen
CHU CAEN
Caen
Clinique Mathilde
Rouen
About this study
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
- Being tested
- Use of a virtual reality headset
- Keywords
- virtual reality headset, stress, hypnose
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a virtual reality headsetBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| using a virtual reality headset | Experimental | Not described Receives: Behavioral: Use of a virtual reality headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before surgery and up to 2 hours after surgery
Secondary outcomes (4)
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)
Measured: up to 1 month after surgery
Pain evaluation (Visual Analog Pain Scale)
Score on the VAS pain scale [minimum value 0, up to maximum value (worse) 10]
Measured: up to 1 month after surgery
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]
Measured: Up to 2 hours after surgery
Taking of anxiolytics
variation of amount of anti-anxiety medication
Measured: up to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start18 Nov 2020
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481893
- Sponsor's protocol ID
- 2020-A00182-37
- Acronym
- ThyroVir
- Status last verified
- Sep 2025
- First submitted
- 7 Jul 2020
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT04481893
- Acronym / sponsor ID
- ThyroVir / 2020-A00182-37
- Conditions
- Thyroid Cancer, Thyroidectomy
- Keywords
- virtual reality headset, stress, hypnose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| using a virtual reality headset | Experimental | Behavioral: Use of a virtual reality headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of a virtual reality headsetThe 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) | Behavioural | using a virtual reality headset |
Primary outcome
Change of Anxiety state (STAI-Y scale)
Time frame: 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)
Time frame: 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.
4 secondary outcomes
Anxiety evaluation by Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: up to 1 month after surgery
Pain evaluation (Visual Analog Pain Scale)
Time frame: up to 1 month after surgery
Satisfaction of patients by EVAN-G scale (Evaluation of the General Anesthesia feelings)
Time frame: Up to 2 hours after surgery
Taking of anxiolytics
Time frame: up to 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of a virtual reality headset in people with Thyroid Cancer and Thyroidectomy, run by Centre Francois Baclesse at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Anxiety state (STAI-Y scale) (time frame: Before surgery and up to 2 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.