A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System

Study Overview
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Brief Summary
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Anxiety is an emotional disorder. It's a painful concern caused by uncertainty. It is a complex phenomenon misunderstood in spite of medical progress. Relaxation is a technical for reduce anxiety and is effective and safe. Previous study demonstrated the impact of session relaxation on the autonomous nervous system by the heart rate variability. Primary objective of this new study is to demonstrate a link between heart rate variability and reduced anxiety during relaxation session.

Detailed Description
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It is monocentric, prospective and interventional study. This study will be proposed at the patients who will have an orthopedic surgery in full hospitalization. These patients are anxious because of surgery too. The day before surgery anesthetist save heart rate variability and value of the partial pressure of carbon dioxide during relaxation session.

Official Title
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A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System

Conditions
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Anxiety, Relaxation

Intervention / Treatment
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* Other: relaxation session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Affiliated or entitled to a social security Have signed consent before their participation in the study Aged over 18 years Patients who will have an orthopedic surgery in full hospitalization Patients anxious on visual analogic scale of anxiety (>5) Exclusion Criteria: Different disorder : disability to understand instructions, respiratory insufficiency, obesity, sleep apnea, wearing a pacemaker Medical history of schizophrenia or bipolar disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients anxious<br>Patients anxious will be perform relaxation session. | Other: relaxation session<br>* During relaxation session, patients anxious will have three electrodes for save heart rate variability and a sensor for save value of the partial pressure of carbon dioxide. Before and after relaxation session, patient evaluates his anxiety by visual analogue scale (VAS) and State-Trait Anxiety Inventory (STAI-Y).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high frequency | from the variation of heart rate. Measured by electrocardiogram. | continuously during the relaxation session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety | Measured with the State-Trait Anxiety Inventory (STAI-Y) Interpretation : Very high:> to 65 High: from 56 to 65 Average: from 46 to 55 Low: from 36 to 45 Very low: <or = 35 | after the relaxation session at day 1 | 
| low frequency | Measured by electrocardiogram. | continuously during the relaxation session | 
| the ratio of high frequencies to low frequencies | Measured by electrocardiogram. | continuously during the relaxation session | 
| PetCO2 | measured with a sensor fixed in front of the nostril | continuously during the relaxation session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative anxiety, Relaxation, Autonomous nervous system, Surgery, Visual Analogue Scale (VAS), State-Trait Anxiety Inventory (STAI-Y)