AnxietyRESC SYMPANCT07070986
Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulation SYMPAthetic and Parasympathetic Tone and Anxiety in Patients Admitted for Cardiac Surgery
An observational study of Anxiety, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- RESC and NSCS
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2025to 3 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients admitted for cardiac surgery with significant preoperative anxiety.
Who may be able to join
- Planned cardiac surgery with extracorporeal circulation
- Pre operatory anxiety : STAI-E score >30 or Visual Analogue Scale Anxiety >6
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopitallouis Pradel
Bron, 69500
CHARRION CHANTAL, 00337 86 50 03 82, chantal.clement-charrion01@chu-lyon.fr
About this study
Official title: Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulation on SYMPAthetic and Parasympathetic Tone and Anxiety in Patients Admitted for Cardiac Surgery
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.
Read more
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).
- Conditions
- Anxiety
- Being tested
- RESC, NSCS
- Keywords
- Anxiety, Cardiac surgery, Pain, RESC
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESCProcedure or surgery
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.
NSCSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: RESC | |
| 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. Receives: Other: NSCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
LF/HF ratio variation compared between the groups
LF and HF will be monitored during the all RESC/NSCS.
Measured: Between the beginning and the end of the RESC/NCS session (20 minutes)
Secondary outcomes (9)
Skin conductance variation compared between the groups
Skin conductance will be monitored during the all RESC/NSC session.
Measured: Between the beginning and the end of the RESC/NCS session (20 minutes)
Perfusion index variations compared between the groups.
Perfusion index ration will be monitored during the all RESC/NSC session.
Measured: 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.
Measured: 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)
Measured: After de RESC/NCS session
Morphine use post-surgery compared between the groups
Cumulative morphine used
Measured: Day 1
Anxiety compared between the groups
Anxiety will be assessed by STAI-E
Measured: After de RESC/NCS session
Heart rate variations compared between the groups.
Heart rate variation will be monitored during the all RESC/NSC session.
Measured: 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.
Measured: 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.
Measured: Between the beginning and the end of the RESC/NCS session (20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start30 Sep 2025
- Primary completion3 Mar 2027 (estimated)
- Study completion3 Mar 2027 (estimated)
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 Hospices Civils de LyonThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070986
- Sponsor's protocol ID
- 69HCL24_1239
- Acronym
- RESC SYMPA
- Status last verified
- Dec 2025
- First submitted
- 23 Jun 2025
- Last updated
- 19 Dec 2025
- Results posted
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulation on SYMPAthetic and Parasympathetic Tone and Anxiety in Patients Admitted for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07070986
- Acronym / sponsor ID
- RESC SYMPA / 69HCL24_1239
- Conditions
- Anxiety
- Keywords
- Anxiety, Cardiac surgery, Pain, RESC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 3 Mar 2027 (estimated)
- Study completion
- 3 Mar 2027 (estimated)
- First posted
- 17 Jul 2025 (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 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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CUTANEOUS RESONANCE STIMULATION (RESC) | – | Procedure: RESCIf 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. |
| NON SPECIFIC CUTANEOUS STIMULATION (NSCS) | – | Other: NSCSIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted for cardiac surgery with significant preoperative anxiety.
Key inclusion criteria (2 listed)
- Planned cardiac surgery with extracorporeal circulation
- Pre operatory anxiety : STAI-E score >30 or Visual Analogue Scale Anxiety >6
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| RESCIf 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. | Procedure or surgery | CUTANEOUS RESONANCE STIMULATION (RESC) |
| NSCSIf 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. | Other | NON SPECIFIC CUTANEOUS STIMULATION (NSCS) |
Primary outcome
LF/HF ratio variation compared between the groups
Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)
LF and HF will be monitored during the all RESC/NSCS.
9 secondary outcomes
Skin conductance variation compared between the groups
Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)
Perfusion index variations compared between the groups.
Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)
Analgesia nociception index compared between the groups
Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)
Anxiety compared between the groups
Time frame: After de RESC/NCS session
Morphine use post-surgery compared between the groups
Time frame: Day 1
Anxiety compared between the groups
Time frame: After de RESC/NCS session
Heart rate variations compared between the groups.
Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)
Blood pressure variations compared between the groups.
Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)
Respiratory rate variations compared between the groups.
Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Hospices Civils de Lyon 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 19 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHARRION Chantal (00337 86 50 03 82, chantal.clement-charrion01@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LF/HF ratio variation compared between the groups (time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)). 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 19 Dec 2025.