The vast majority of tooth extraction surgery is performed under local anaesthetic, and can be a source of anxiety. In their 2015 article, Appukuttan et al studied the anxiety felt by 1148 patients prior to tooth extraction, and reported up to 82% of patients anxious before a procedure. In 2020, Yamashita et al demonstrated the value of virtual reality in reducing patient anxiety during the extraction of three impacted mandibular molars, with no clear effect on the pain felt by the patient. The use of a virtual reality headset has been shown to reduce anxiety in dental surgery or in hand surgery under local anesthesia with the WALANT technique. On the other hand, virtual reality and the use of 3D can cause discomfort and side effects such as nausea and dizziness. Audiovisual distraction is also known to be effective in reducing pain and anxiety in patients, with fewer side effects. The investigators have therefore chosen to use RELAX® eyewear. They wish to study its effect on anxiety, pain and overall patient and surgeon satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
106
Glasses which are a solution of audiovisual sedation by positiv distraction for hospital medical use
Centre Hospitalier de Valenciennes
Valenciennes, France, France
Change from baseline in visual analogue scale anxiety scores after tooth extraction
The visual analogue anxiety scale from 0 to 10, with meaning no anxiety and 10 very high anxiety
Time frame: In the 5 minutes after the end of surgery
Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale
The visual analogue satisfaction scale ranges from 0 to 10, with 0 eaning unsatisfaction and 10indicating very high satisfaction
Time frame: Immediative postoperative
Variation in pain between entering and leaving the surgical technical platform between the 2 arms using a visual analogue scale
The visual analogue pain scal range from 0 to 10, with 0 meaning non pain and 10 very high pain
Time frame: In the 5 minutes after the end of surgery
Rate of patients receiving at least one analgesic
Time frame: After local anesthesia
Surgeon's satisfaction with the feasibility of the procedure in a patient wearing RELAX glasses filling in a self-assessment questionnaire
Self-assessment questionnaire consists of 2 questions : Assessment of the severity of the operation on a scale of 0 to 10. 0 indicates no severity and 10 extreme severity. Assessment of patient compliance on a scale from 0 to 10. 0 indicating that the patient was completely compliant and 10 indicating absolutely non-compliant.
Time frame: Immediative postoperative
Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score
Only in patients receiving RELAX glasses : if the STAY-IB score is higher than 65, the patient is considered to have pre-existing anxiety
Time frame: 7 days (+/-3 days) after surgery
Evaluation of the impact of patient agitation on the operative procedure by filling in a self-assessment questionnaire after each operative procedure.
The questionnary consists of 5 statements. The surgeon must tick only one of them (it's not a scale) * the patient was not agitated * The patient was agitated, but this had no impact on the surgical procedure * Patient agitation caused a change in the surgical procedure * Patient agitation was the cause of a temporary suspension of the surgical procedure * The patient's agitation is too great to consider continuing the procedure under local anaesthetic.
Time frame: Immediative postoperative
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