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Completed

NCT Number: NCT03324048

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Relaxation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. high frequency

    Time frame: continuously during the relaxation session

    from the variation of heart rate. Measured by electrocardiogram.

Secondary outcomes

  1. anxiety

    Time frame: 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

  2. low frequency

    Time frame: continuously during the relaxation session

    Measured by electrocardiogram.

  3. the ratio of high frequencies to low frequencies

    Time frame: continuously during the relaxation session

    Measured by electrocardiogram.

  4. PetCO2

    Time frame: continuously during the relaxation session

    measured with a sensor fixed in front of the nostril

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2017
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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