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Completed

NCT Number: NCT04481893

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

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

Completed

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroidectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU CAEN, Caen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of a virtual reality headset

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)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Anxiety evaluation by Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Time frame: 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)

  2. Pain evaluation (Visual Analog Pain Scale)

    Time frame: up to 1 month after surgery

    Score on the VAS pain scale [minimum value 0, up to maximum value (worse) 10]

  3. Satisfaction of patients by EVAN-G scale (Evaluation of the General Anesthesia feelings)

    Time frame: Up to 2 hours after surgery

    score of EVAN-G questionnaire [minimum value 0, up to maximum value (worse) 100]

  4. Taking of anxiolytics

    Time frame: up to 1 month after surgery

    variation of amount of anti-anxiety medication

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: ThyroVir

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2020
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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