AnxietyNCT03324048
A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System
A study testing relaxation session in people with Anxiety and Relaxation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Relaxation
- What is being tested?
- relaxation session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2017to 17 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Different disorder : disability to understand instructions, respiratory insufficiency, obesity, sleep apnea, wearing a pacemaker
- Medical history of schizophrenia or bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety, Relaxation
- Being tested
- relaxation session
- Keywords
- Preoperative anxiety, Relaxation, Autonomous nervous system, Surgery, Visual Analogue Scale (VAS), State-Trait Anxiety Inventory (STAI-Y)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxation sessionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients anxious | Other | Patients anxious will be perform relaxation session. Receives: Other: relaxation session |
What is being measured
The primary outcome is the main question the study is designed to answer.
high frequency
from the variation of heart rate. Measured by electrocardiogram.
Measured: continuously during the relaxation session
Secondary outcomes (4)
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
Measured: after the relaxation session at day 1
low frequency
Measured by electrocardiogram.
Measured: continuously during the relaxation session
the ratio of high frequencies to low frequencies
Measured by electrocardiogram.
Measured: continuously during the relaxation session
PetCO2
measured with a sensor fixed in front of the nostril
Measured: continuously during the relaxation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start14 Nov 2017
- Primary completion17 Sep 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeina PRADES, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324048
- Sponsor's protocol ID
- 1708097
- Other IDs
- ID-RCB
- Status last verified
- Jul 2018
- First submitted
- 5 Oct 2017
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System
- ClinicalTrials.gov ID
- NCT03324048
- Acronym / sponsor ID
- 1708097
- Conditions
- Anxiety, Relaxation
- Keywords
- Preoperative anxiety, Relaxation, Autonomous nervous system, Surgery, Visual Analogue Scale (VAS), State-Trait Anxiety Inventory (STAI-Y)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients anxious | Other | Other: relaxation sessionPatients anxious will be perform relaxation session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- Different disorder : disability to understand instructions, respiratory insufficiency, obesity, sleep apnea, wearing a pacemaker
- Medical history of schizophrenia or bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| relaxation sessionDuring 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). | Other | Patients anxious |
Primary outcome
high frequency
Time frame: continuously during the relaxation session
from the variation of heart rate. Measured by electrocardiogram.
4 secondary outcomes
anxiety
Time frame: after the relaxation session at day 1
low frequency
Time frame: continuously during the relaxation session
the ratio of high frequencies to low frequencies
Time frame: continuously during the relaxation session
PetCO2
Time frame: continuously during the relaxation session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeina PRADES, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relaxation session in people with Anxiety and Relaxation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high frequency (time frame: continuously during the relaxation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.