An interventional study of relaxation session in Anxiety and Relaxation, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-17.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other
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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.
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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 33 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients anxious will be perform relaxation session.
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).
high frequency
from the variation of heart rate. Measured by electrocardiogram.
Time frame: continuously during the relaxation session
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
Time frame: after the relaxation session at day 1
low frequency
Measured by electrocardiogram.
Time frame: continuously during the relaxation session
the ratio of high frequencies to low frequencies
Measured by electrocardiogram.
Time frame: continuously during the relaxation session
PetCO2
measured with a sensor fixed in front of the nostril
Time frame: continuously during the relaxation session
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Sep 2018, 10 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 10 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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