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Anxiety is a natural response to stress which peaks just before the surgery procedure. High levels of anxiety can increase postoperative pain and complications. Medicated anxiolysis is no longer recommended, in the absence of proven efficacy. Other interventions to prevent anxiety are required.
The autonomic nervous system (ANS), both sympathetic and parasympathetic, determines the response to stress. Anxiety interventions such as hypnosis, massage and relaxation work by modulating ANS tone. The ANS also modulates heart rate.
Anxiety can be measured by RR space, from which HRV, high-frequency (HF) and low-frequency (LF) are components respectively linked to the parasympathetic and sympathetic systems. The LF/HF ratio reflects sympathetic dominance if high, and parasympathetic dominance if low.
Cutaneous resonance stimulation (RESC) is a manual technique. RESC can diagnose and correct energy imbalances by skin stimulation between two points and thus act on anxiety.
We hypothesized that a preoperative RESC session would modify the sympathetic/parasympathetic balance and reduce anxiety in patients admitted for cardiac surgery, compared to patient receiving a sham RESC session: non-specific cutaneous stimulation (NSCS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CUTANEOUS RESONANCE STIMULATION (RESC) | If randomized in the RESC group, interventional group, patient will receive a 20 minutes session of cutaneous resonance stimulation before his cardiac surgery according to a standardized protocol. |
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| NON SPECIFIC CUTANEOUS STIMULATION (NSCS) | If randomized in the NSCS group, control group, patient will receive a 20 minutes session of non-specific cutaneous stimulation before his cardiac surgery according to a standardized protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESC | Procedure | If randomized in the RESC group, interventional group, patient will receive a 20 minutes session of cutaneous resonance stimulation before his cardiac surgery. He will be asked to respond to anxiety questionnaire STAI-E and to evaluate his anxiety on a visual analogue scale (VAS) at J-1 (day of inclusion), J0 (day of surgery), and J1 (the day after surgery). During the RESC session, LF/HF ratio, ANI, heart rate, respiratory rate, perfusion index and skin conductance will be monitored. |
| Measure | Description | Time Frame |
|---|---|---|
| LF/HF ratio variation compared between the groups | LF and HF will be monitored during the all RESC/NSCS. | Between the beginning and the end of the RESC/NCS session (20 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Skin conductance variation compared between the groups | Skin conductance will be monitored during the all RESC/NSC session. | Between the beginning and the end of the RESC/NCS session (20 minutes) |
| Perfusion index variations compared between the groups. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted for cardiac surgery with significant preoperative anxiety.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CHARRION Chantal | Contact | 00337 86 50 03 82 | chantal.clement-charrion01@chu-lyon.fr | |
| CANTERINI JULIA | Contact | 00334 27 85 66 28 | Julia.canterini@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopitallouis Pradel | Recruiting | Bron | 69500 | France |
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| NSCS | Other | If randomized in the NSCS group, interventional group, patient will receive a 20 minutes session of non-specific cutaneous stimulation before his cardiac surgery. He will be asked to respond to anxiety questionnaire STAI-E and to evaluate his anxiety on a visual analogue scale at J-1 (day of inclusion), J0 (day of surgery), and J1 (the day after surgery) During the NSCS session, LF/HF ratio, ANI, heart rate, respiratory rate, perfusion index and skin conductance will be monitored. |
|
Perfusion index ration will be monitored during the all RESC/NSC session. |
| Between the beginning and the end of the RESC/NCS session (20 minutes) |
| Analgesia nociception index compared between the groups | Analgesia nociception index will be monitored during the all RESC/NSC session. | Between the beginning and the end of the RESC/NCS session (20 minutes) |
| Anxiety compared between the groups | Anxiety will be assessed by visual analogue scale between 0 (no anxiety) and 10 (worst anxiety) | After de RESC/NCS session |
| Morphine use post-surgery compared between the groups | Cumulative morphine used | Day 1 |
| Anxiety compared between the groups | Anxiety will be assessed by STAI-E | After de RESC/NCS session |
| Heart rate variations compared between the groups. | Heart rate variation will be monitored during the all RESC/NSC session. | Between the beginning and the end of the RESC/NCS session (20 minutes) |
| Blood pressure variations compared between the groups. | Blood pressure be monitored during the all RESC/NSC session. | Between the beginning and the end of the RESC/NCS session (20 minutes) |
| Respiratory rate variations compared between the groups. | Respiratory rate will be monitored during the all RESC/NSC session. | Between the beginning and the end of the RESC/NCS session (20 minutes) |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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