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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324048
• Other study ID #: 1708097
• Secondary ID: ID-RCB
• Status: Completed
• Phase: N/A
• Start date: November 14, 2017
• Est. completion date: September 17, 2018

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Relaxation

Intervention

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).

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high frequency	from the variation of heart rate. Measured by electrocardiogram.	continuously during the relaxation session
Secondary	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:	after the relaxation session at day 1
Secondary	low frequency	Measured by electrocardiogram.	continuously during the relaxation session
Secondary	the ratio of high frequencies to low frequencies	Measured by electrocardiogram.	continuously during the relaxation session
Secondary	PetCO2	measured with a sensor fixed in front of the nostril	continuously during the relaxation session