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

Not Applicable

Completed

• Conditions: Relaxation; Anxiety
• Interventions: Other: relaxation session

• Registration Number: NCT03324048
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-27
• Study Start: 2017-11-14
• Status Verified: 2018-07
• Primary Completion: 2018-09-17
• Study Completion: 2018-09-17
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients anxious	relaxation session	Patients anxious will be perform relaxation session.

Primary Outcome Measures

Name	Time	Method
high frequency	continuously during the relaxation session	from the variation of heart rate. Measured by electrocardiogram.

Secondary Outcome Measures

Name	Time	Method
anxiety	after the relaxation session at day 1	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
low frequency	continuously during the relaxation session	Measured by electrocardiogram.
the ratio of high frequencies to low frequencies	continuously during the relaxation session	Measured by electrocardiogram.
PetCO2	continuously during the relaxation session	measured with a sensor fixed in front of the nostril

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France