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

NCT03324048 | Completed

• 2 other identifiers: 1708097ID-RCB
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Relaxation

Keywords

Preoperative anxiety; Relaxation; Autonomous nervous system; Surgery; Visual Analogue Scale (VAS); State-Trait Anxiety Inventory (STAI-Y)

Outcome Measures

Primary Outcomes (1)

• high frequency

  from the variation of heart rate. Measured by electrocardiogram.

  continuously during the relaxation session

Secondary Outcomes (4)

• anxiety

  after the relaxation session at day 1

• low frequency

  continuously during the relaxation session

• the ratio of high frequencies to low frequencies

  continuously during the relaxation session

• PetCO2

  continuously during the relaxation session

Study Arms (1)

Patients anxious

OTHER

Patients anxious will be perform relaxation session.

Other: relaxation session

Interventions

relaxation session OTHER

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).

Patients anxious

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Different disorder : disability to understand instructions, respiratory insufficiency, obesity, sleep apnea, wearing a pacemaker
• Medical history of schizophrenia or bipolar disorder

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Zeina PRADES, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 27, 2017
• Study Start: November 14, 2017
• Primary Completion: September 17, 2018
• Study Completion: September 17, 2018
• Last Updated: May 17, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)