Anxiety
Conditions
Keywords
Anxiety, Cardiac surgery, Pain, RESC
Brief summary
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).
Interventions
PROCEDURERESC
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.
OTHERNSCS
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.
Sponsors
Hospices Civils de Lyon
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned cardiac surgery with extracorporeal circulation * Pre operatory anxiety : STAI-E score \>30 or Visual Analogue Scale Anxiety \>6
Exclusion criteria
* Urgent surgery * Atrial fibrillation * Impossibility to answer to STAI-E or VAS * Use of alternative method * Use of an alternative method other for anxiety before inclusion * Absence of consent * Pregnant, breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LF/HF ratio variation compared between the groups | Between the beginning and the end of the RESC/NCS session (20 minutes) | LF and HF will be monitored during the all RESC/NSCS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perfusion index variations compared between the groups. | Between the beginning and the end of the RESC/NCS session (20 minutes) | Perfusion index ration will be monitored during the all RESC/NSC session. |
| Analgesia nociception index compared between the groups | Between the beginning and the end of the RESC/NCS session (20 minutes) | Analgesia nociception index will be monitored during the all RESC/NSC session. |
| Anxiety compared between the groups | After de RESC/NCS session | Anxiety will be assessed by visual analogue scale between 0 (no anxiety) and 10 (worst anxiety) |
| Skin conductance variation compared between the groups | Between the beginning and the end of the RESC/NCS session (20 minutes) | Skin conductance will be monitored during the all RESC/NSC session. |
| Heart rate variations compared between the groups. | Between the beginning and the end of the RESC/NCS session (20 minutes) | Heart rate variation will be monitored during the all RESC/NSC session. |
| Blood pressure variations compared between the groups. | Between the beginning and the end of the RESC/NCS session (20 minutes) | Blood pressure be monitored during the all RESC/NSC session. |
| Respiratory rate variations compared between the groups. | Between the beginning and the end of the RESC/NCS session (20 minutes) | Respiratory rate will be monitored during the all RESC/NSC session. |
| Morphine use post-surgery compared between the groups | Day 1 | Cumulative morphine used |
Countries
France
Contacts
Primary ContactCHARRION Chantal
Backup ContactCANTERINI JULIA
Outcome results
None listed