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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Relaxation
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients anxious; Patients anxious will be perform relaxation session.	Other: relaxation session; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Zeina PRADES, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2017
• Primary Completion (Actual): September 17, 2018
• Study Completion (Actual): September 17, 2018

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Surgery; Relaxation; Preoperative anxiety; Autonomous nervous system; Visual Analogue Scale (VAS); State-Trait Anxiety Inventory (STAI-Y)
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 1708097; ID-RCB (Other Identifier: 2026-A00289-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No