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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03324048
Enrollment
33
Registered
2017-10-27
Start date
2017-11-14
Completion date
2018-09-17
Last updated
2019-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Relaxation

Keywords

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

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.

Interventions

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).

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
high frequencycontinuously during the relaxation sessionfrom the variation of heart rate. Measured by electrocardiogram.

Secondary

MeasureTime frameDescription
anxietyafter the relaxation session at day 1Measured 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 frequencycontinuously during the relaxation sessionMeasured by electrocardiogram.
the ratio of high frequencies to low frequenciescontinuously during the relaxation sessionMeasured by electrocardiogram.
PetCO2continuously during the relaxation sessionmeasured with a sensor fixed in front of the nostril

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026