Back to resultsA Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System
Primary Purpose
Anxiety, Relaxation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
relaxation session
Sponsored by
About this trial
This is an interventional other trial for Anxiety focused on measuring Preoperative anxiety, Relaxation, Autonomous nervous system, Surgery, Visual Analogue Scale (VAS), State-Trait Anxiety Inventory (STAI-Y)
Eligibility Criteria
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
Sites / Locations
- CHU de SAINT-ETIENNE
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients anxious
Arm Description
Patients anxious will be perform relaxation session.
Outcomes
Primary Outcome Measures
high frequency
from the variation of heart rate. Measured by electrocardiogram.
Secondary Outcome Measures
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
low frequency
Measured by electrocardiogram.
the ratio of high frequencies to low frequencies
Measured by electrocardiogram.
PetCO2
measured with a sensor fixed in front of the nostril
Full Information
NCT ID
NCT03324048
First Posted
October 5, 2017
Last Updated
May 15, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT03324048
Brief Title
A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System
Official Title
A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
September 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Relaxation
Keywords
Preoperative anxiety, Relaxation, Autonomous nervous system, Surgery, Visual Analogue Scale (VAS), State-Trait Anxiety Inventory (STAI-Y)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients anxious
Arm Type
Other
Arm Description
Patients anxious will be perform relaxation session.
Intervention Type
Other
Intervention Name(s)
relaxation session
Intervention Description
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 Outcome Measure Information:
Title
high frequency
Description
from the variation of heart rate. Measured by electrocardiogram.
Time Frame
continuously during the relaxation session
Secondary Outcome Measure Information:
Title
anxiety
Description
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
Time Frame
after the relaxation session at day 1
Title
low frequency
Description
Measured by electrocardiogram.
Time Frame
continuously during the relaxation session
Title
the ratio of high frequencies to low frequencies
Description
Measured by electrocardiogram.
Time Frame
continuously during the relaxation session
Title
PetCO2
Description
measured with a sensor fixed in front of the nostril
Time Frame
continuously during the relaxation session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeina PRADES, MD PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System
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