SurgeryCOHEC2NCT05197972
Assessment of Cardiac Coherence Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
A study testing cardiac coherence program coupled with hypnosis in people with Surgery and Oncology, run by Institut du Cancer de Montpellier - Val d'Aurelle at 4 sites in France.
Trial summary
The investigator proposes to use the cardiac coherence technique (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- cardiac coherence program coupled with hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Jun 2022to Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years old
- Patient with a scheduled surgery for a cancer (suspected or declared) with a classic or ambulatory hospitalization
- Patients requiring general anesthesia with or without associated loco-regional anesthesia or loco-regional anesthesia alone
- Patient with a smartphone or a tablet or a computer and able to install the application
- Inclusion of the patient minimum 7 days before the date of the surgery
- Patient who signed the informed consent
- Patient affiliated to a French social security system
Who cannot join
- Emergency surgery
- Plastic surgery for reconstruction: lipomodelling
- Prophylactic surgery: no suspected or existing cancer
- Bradycardia (< 50 beats/minute) with β-blockers
- Severe heart failure with ventricular ejection fraction < 40%
- Uncontrolled chronic pain for more than three months on morphine
Show all 11Show fewer
- Patient with unstable epilepsy or respiratory pathology with rest dyspnea
- Patient used to and having a regular and habitual practice of relaxation techniques such as yoga, hypnosis, sophrology, meditation, music therapy, virtual reality, ...
- Medical (neurological, psychiatric, etc.) or psychological conditions not allow for participation in the protocol (completion of questionnaires and booklet, compliance with the cardiac coherence program coupled with hypnosis)
- Deaf patient without hearing aids
- Patient under guardianship or curatorship
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Centre Léon Bérard
Lyon
Grégoire MD WALLON, +334 78 78 29 71, gregoire.wallon@lyon.unicancer.fr
Grégoire MD WALLON
- Recruiting
Institut régional du cancer de Montpellier
Montpellier, Hérault, 34298
Jibba AMRAOUI, MD, 4 67 61 30 81 ext. +33, jibba.amraoui@icm.unicancer.fr
- Not yet recruiting
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse
Régis FUZIER, MD, fuzier.regis@iuct-oncopole.fr
- Not yet recruiting
Institut Gustave Roussy
Villejuif
Alexandra VOICU, MD, +331 42 11 59 34, alexandre.voicu@gustaveroussy.fr
About this study
Official title: Phase III Study Evaluating a Non-drug Intervention (NDI) Program by Fixed-frequency Guided Breathing (Cardiac Coherence) Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
The investigator proposes to use the cardiac coherence technique (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety.
Read the detailed description
The perioperative period is recognized as anxiety-provoking for most patients. In oncology, 60 to 80% of patients suffer from stress throughout their treatment. If for some patients, this anxiety is more or less manageable, for others, it is the major concern with regard to their intervention.
For many years, pharmacological premedication, especially with benzodiazepines, has been the gold standard for the treatment of preoperative anxiety, but this systematic prescription is increasingly controversial, especially in populations most exposed to side effects, such as elderly subjects and patients with cardiac or respiratory pathologies.
The aim of this study is to propose an alternative to pharmacological premedication by a non-drug approach.
The two techniques (the Fixed Rate Guided Breathing Technique = cardiac coherence and hypnosis) can potentiate each other and become synergistic. Thus, for patients undergoing oncological surgery, regular practice of cardiac coherence coupled with hypnosis prior to their surgery should enable them to better manage perioperative anxiety and thus significantly reduce their level of anxiety on the day of their surgery.
The association of the 2 techniques combines several advantages:
- It is totally "physiological", free and immediately available for the patient and without any undesirable effect;
- It gives autonomy to the patient to manage his stress, making him independent of chemical molecules, the presence of a third party or expensive equipment.
- It will allow oncology patients to use it throughout their care (invasive examinations, MRI imaging, heavy and complex care such as certain dressings, etc.)
This work will allow:
- To give oncology patients the possibility to be actors of their care by a self-management of their anxiety in substitution or complement of a medicated approach;
- To map anxiety in oncology surgery using a simple scale such as the EVA, which has not yet been done;
- To identify the most anxious patients in order to provide them with the appropriate management (pharmacological and/or NMI) before their surgery;
- To evaluate the correlation between the level of preoperative anxiety and the occurrence of postoperative adverse events;
- To evaluate the correlation between the level of anxiety and the quality of recovery (QoR) and the postoperative experience (EVAN-G).
Patients in the experimental group will be interviewed to explain how to perform the cardiac coherence and hypnosis sessions at home before the surgery.
- Being tested
- cardiac coherence program coupled with hypnosis
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac coherence program coupled with hypnosisOther
At home the patient will perform the cardiac coherence sessions between 7 days and a maximum of 15 days before the surgery through the application "Respirelax": 3 sessions per day, lasting 5 minutes with a breathing frequency of 6 cycles/min for a period of 7 days minimum and maximum 15 days.
An audio tape read in a hypnotic tone can be listened to by the patient during the cardiac coherence program or at another time of the day (see the text of the audio tape).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Classic management of the preoperative period with a cardiac coherence program coupled with hypnosis. Receives: Other: cardiac coherence program coupled with hypnosis |
| Control group | No intervention | Classic management of the preoperative period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) of global anxiety
Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).
Measured: The morning of the surgery (Day 0) upon arrival in the operating room
Secondary outcomes (16)
Program compliance
Program compliance rate of patients in the experimental group. A patient is considered compliant if he declares to have completed at least 2/3 of the proposed Cardiac Coherence sessions + listening to hypnotic tape (at least 5 days /7).
Measured: Between -15 to -7 days before surgery (Day -15 to Day -7) until the day of surgery (Day 0)
Measurement of global and specific anxiety level by using a Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) of anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety). The patient assesses his global and specific anxiety related to: surgery, anesthesia, COVID infectious risk, fear of the unknown, oncological disease
Measured: Between -15 to -7 days before surgery (Day -15 to Day -7)
Measurement of global anxiety level by using a Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).
Measured: Between -15 to -7 days before surgery and the day of surgery (Day 0)
The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a self-report questionnaire comprising six questions that have been developed and validated to evaluate the preoperative anxiety of patients. This global index assesses three separate areas: anxiety about anaesthesia, anxiety about surgery, and the desire for information.
The scale scores six items from 1 to 5 (1 = absence, 5 = extreme). The APAIS scale will be used to determine the psychological profile of patients between "blunting" and "monitoring" types
Measured: Between -15 to -7 days before surgery
VAS values and individual psycho-clinical characteristics
Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety) (defined as VAS at Day 0 ≥ 40), and individual psycho-clinical characteristics (gender, smoking, psychological questionnaires).
Measured: Between -15 to -7 days before surgery and the day of surgery (Day 0)
Number of patients taking benzodiazepine
Rate of patients taking benzodiazepines in the 2 groups
Measured: The day after surgery (Day 1)
Number of days of hospitalization
Length of hospital stay in the 2 groups
Measured: The day after surgery (Day -1) and up to 1 month
VAS values and mode of hospitalization and importance of the surgical procedure
Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor, and the mode of hospitalization (ambulatory or conventional) and the importance of the surgical procedure (minor, intermediate or major)
Measured: The morning of the surgery (Day 0) upon arrival in the operating room
Doses of hypnotic and morphine drugs
Doses of hypnotic and morphine drugs administered during anesthetic induction (Day 0) in the 2 groups
Measured: During anesthetic induction (Day 0)
Value of preoperative VAS and adverse events
Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor and adverse event variables: pain, agitation, postoperative nausea and vomiting (PONV), ...
Measured: The morning of the surgery (Day 0) upon arrival in the operating room
Number of Self-questionnaire completed
Self-questionnaire completion rates for each of the 2 pre- and postoperative periods
Measured: From the day of the anesthesia consultation until the end of the study
Evaluation of the Vecu of General Anesthesia questionnaire (EVAN-G)
The EVAN-G questionnaire includes 26 questions whose results are grouped together to define 6 dimensions: Attention Focus, Information, Privacy, Pain, Discomfort and Wait Times. From these scores, an overall satisfaction score is calculated. The total score of the six dimensions reduced to 100.
Measured: Two day after surgery (Day 2)
Visual Analogue Scale (VAS) of pain
Visual Analogue Scale (VAS) of pain is a pain self-assessment scale that allows the patient to self-assess his or her pain using a cursor
Measured: At 1, 2 and 3 month after surgery
Quality of Recovery (QoR)
The QoR-15 questionnaire assesses five dimensions of recovery : physical comfort; emotional state; physical independence; physiological support; and pain. Each item was rated on a ten-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score of 15 ranges from 0 (poorest quality of recovery) to 150 (best quality of recovery).
Measured: The day after surgery (Day 1)
Insomnia Severity Index Scale (ISI)
The Insomnia Severity Index (ISI) includes 7 questions which assesses the nature of the insomnia, the person's satisfaction with sleep, daily functioning and anxiety about sleep problems. Add scores for all seven items, sum from 0-7 = No clinically significant insomnia to 22-28 = Clinical insomnia (severe).
Measured: The day after surgery (Day 1)
VAS of on satisfaction with overall management and anesthesia
Visual Analogue Scale (VAS) of on satisfaction with overall management and anesthesia is a satisfaction self-assessment scale that allows the patient to self-assess his or her satisfaction using a cursor. The scale ranges from 0 (not at all satisfied) to 100 (completely satisfied)
Measured: The day after surgery (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Jun 2022
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group : classic management of the preoperative period Experimental group: classic management of the preoperative period with a cardiac coherence program coupled with hypnosis
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jibba AMRAOUI, MD, Study chair, Institut régional du cancer de MontpellierRégis FUZIER, MD, Principal investigator, Institut Universitaire du Cancer Toulouse - OncopoleLauriane Bordevane, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197972
- Sponsor's protocol ID
- PROICM 2021-09 COH
- Other IDs
- 2021-A01524-37
- Acronym
- COHEC2
- Status last verified
- Apr 2025
- First submitted
- 8 Dec 2021
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
Publications
Pekcan M, Celebioglu B, Demir B, Saricaoglu F, Hascelik G, Yukselen MA, Basgul E, Aypar U. The effect of premedication on preoperative anxiety. Middle East J Anaesthesiol. 2005 Jun;18(2):421-33.
PubMed 16438017Shevde K, Panagopoulos G. A survey of 800 patients' knowledge, attitudes, and concerns regarding anesthesia. Anesth Analg. 1991 Aug;73(2):190-8. doi: 10.1213/00000539-199108000-00013.
PubMed 1854034Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. doi: 10.1034/j.1399-6576.2001.045003298.x.
PubMed 11207465Miller SM. Coping with impending stress: psychophysiological and cognitive correlates of choice. Psychophysiology. 1979 Nov;16(6):572-81. doi: 10.1111/j.1469-8986.1979.tb01523.x. No abstract available.
PubMed 515298Miller SM, Mangan CE. Interacting effects of information and coping style in adapting to gynecologic stress: should the doctor tell all? J Pers Soc Psychol. 1983 Jul;45(1):223-36. doi: 10.1037//0022-3514.45.1.223.
PubMed 6886967Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.
PubMed 10702461Jamison RN, Taft K, O'Hara JP, Ferrante FM. Psychosocial and pharmacologic predictors of satisfaction with intravenous patient-controlled analgesia. Anesth Analg. 1993 Jul;77(1):121-5.
PubMed 8317718Kulik JA, Mahler HI, Moore PJ. Social comparison and affiliation under threat: effects on recovery from major surgery. J Pers Soc Psychol. 1996 Nov;71(5):967-79. doi: 10.1037//0022-3514.71.5.967.
PubMed 8939044Munoz HR, Dagnino JA, Rufs JA, Bugedo GJ. Benzodiazepine premedication causes hypoxemia during spinal anesthesia in geriatric patients. Reg Anesth. 1992 May-Jun;17(3):139-42.
PubMed 1606095Agelink MW, Majewski TB, Andrich J, Mueck-Weymann M. Short-term effects of intravenous benzodiazepines on autonomic neurocardiac regulation in humans: a comparison between midazolam, diazepam, and lorazepam. Crit Care Med. 2002 May;30(5):997-1006. doi: 10.1097/00003246-200205000-00008.
PubMed 12006794Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.
PubMed 25734733Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.
PubMed 25101026Jiang H, White MP, Greicius MD, Waelde LC, Spiegel D. Brain Activity and Functional Connectivity Associated with Hypnosis. Cereb Cortex. 2017 Aug 1;27(8):4083-4093. doi: 10.1093/cercor/bhw220.
PubMed 27469596McCraty R, Atkinson M, Tiller WA, Rein G, Watkins AD. The effects of emotions on short-term power spectrum analysis of heart rate variability. Am J Cardiol. 1995 Nov 15;76(14):1089-93. doi: 10.1016/s0002-9149(99)80309-9.
PubMed 7484873Amraoui J, Pouliquen C, Fraisse J, Dubourdieu J, Rey Dit Guzer S, Leclerc G, de Forges H, Jarlier M, Gutowski M, Bleuse JP, Janiszewski C, Diaz J, Cuvillon P. Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial. JAMA Netw Open. 2018 Aug 3;1(4):e181164. doi: 10.1001/jamanetworkopen.2018.1164.
PubMed 30646110
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study Evaluating a Non-drug Intervention (NDI) Program by Fixed-frequency Guided Breathing (Cardiac Coherence) Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
- ClinicalTrials.gov ID
- NCT05197972
- Acronym / sponsor ID
- COHEC2 / PROICM 2021-09 COH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Jan 2022 (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.
The investigator proposes to use the cardiac coherence technique (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety.
Detailed description
The perioperative period is recognized as anxiety-provoking for most patients. In oncology, 60 to 80% of patients suffer from stress throughout their treatment. If for some patients, this anxiety is more or less manageable, for others, it is the major concern with regard to their intervention.
For many years, pharmacological premedication, especially with benzodiazepines, has been the gold standard for the treatment of preoperative anxiety, but this systematic prescription is increasingly controversial, especially in populations most exposed to side effects, such as elderly subjects and patients with cardiac or respiratory pathologies.
The aim of this study is to propose an alternative to pharmacological premedication by a non-drug approach.
The two techniques (the Fixed Rate Guided Breathing Technique = cardiac coherence and hypnosis) can potentiate each other and become synergistic. Thus, for patients undergoing oncological surgery, regular practice of cardiac coherence coupled with hypnosis prior to their surgery should enable them to better manage perioperative anxiety and thus significantly reduce their level of anxiety on the day of their surgery.
The association of the 2 techniques combines several advantages:
- It is totally "physiological", free and immediately available for the patient and without any undesirable effect;
- It gives autonomy to the patient to manage his stress, making him independent of chemical molecules, the presence of a third party or expensive equipment.
- It will allow oncology patients to use it throughout their care (invasive examinations, MRI imaging, heavy and complex care such as certain dressings, etc.)
This work will allow:
- To give oncology patients the possibility to be actors of their care by a self-management of their anxiety in substitution or complement of a medicated approach;
- To map anxiety in oncology surgery using a simple scale such as the EVA, which has not yet been done;
- To identify the most anxious patients in order to provide them with the appropriate management (pharmacological and/or NMI) before their surgery;
- To evaluate the correlation between the level of preoperative anxiety and the occurrence of postoperative adverse events;
- To evaluate the correlation between the level of anxiety and the quality of recovery (QoR) and the postoperative experience (EVAN-G).
Patients in the experimental group will be interviewed to explain how to perform the cardiac coherence and hypnosis sessions at home before the surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group : classic management of the preoperative period Experimental group: classic management of the preoperative period with a cardiac coherence program coupled with hypnosis
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: cardiac coherence program coupled with hypnosisClassic management of the preoperative period with a cardiac coherence program coupled with hypnosis. |
| Control group | No intervention | –Classic management of the preoperative period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Patient with a scheduled surgery for a cancer (suspected or declared) with a classic or ambulatory hospitalization
- Patients requiring general anesthesia with or without associated loco-regional anesthesia or loco-regional anesthesia alone
- Patient with a smartphone or a tablet or a computer and able to install the application
- Inclusion of the patient minimum 7 days before the date of the surgery
Key exclusion criteria (11 listed)
- Emergency surgery
- Plastic surgery for reconstruction: lipomodelling
- Prophylactic surgery: no suspected or existing cancer
- Bradycardia (< 50 beats/minute) with β-blockers
- Severe heart failure with ventricular ejection fraction < 40%
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 |
|---|---|---|
| cardiac coherence program coupled with hypnosisAt home the patient will perform the cardiac coherence sessions between 7 days and a maximum of 15 days before the surgery through the application "Respirelax": 3 sessions per day, lasting 5 minutes with a breathing frequency of 6 cycles/min for a period of 7 days minimum and maximum 15 days. An audio tape read in a hypnotic tone can be listened to by the patient during the cardiac coherence program or at another time of the day (see the text of the audio tape). | Other | Experimental group |
Primary outcome
Visual Analogue Scale (VAS) of global anxiety
Time frame: The morning of the surgery (Day 0) upon arrival in the operating room
Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).
16 secondary outcomes
Program compliance
Time frame: Between -15 to -7 days before surgery (Day -15 to Day -7) until the day of surgery (Day 0)
Measurement of global and specific anxiety level by using a Visual Analogue Scale (VAS)
Time frame: Between -15 to -7 days before surgery (Day -15 to Day -7)
Measurement of global anxiety level by using a Visual Analogue Scale (VAS)
Time frame: Between -15 to -7 days before surgery and the day of surgery (Day 0)
The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: Between -15 to -7 days before surgery
VAS values and individual psycho-clinical characteristics
Time frame: Between -15 to -7 days before surgery and the day of surgery (Day 0)
Number of patients taking benzodiazepine
Time frame: The day after surgery (Day 1)
Number of days of hospitalization
Time frame: The day after surgery (Day -1) and up to 1 month
VAS values and mode of hospitalization and importance of the surgical procedure
Time frame: The morning of the surgery (Day 0) upon arrival in the operating room
Doses of hypnotic and morphine drugs
Time frame: During anesthetic induction (Day 0)
Value of preoperative VAS and adverse events
Time frame: The morning of the surgery (Day 0) upon arrival in the operating room
Number of Self-questionnaire completed
Time frame: From the day of the anesthesia consultation until the end of the study
Evaluation of the Vecu of General Anesthesia questionnaire (EVAN-G)
Time frame: Two day after surgery (Day 2)
Visual Analogue Scale (VAS) of pain
Time frame: At 1, 2 and 3 month after surgery
Quality of Recovery (QoR)
Time frame: The day after surgery (Day 1)
Insomnia Severity Index Scale (ISI)
Time frame: The day after surgery (Day 1)
VAS of on satisfaction with overall management and anesthesia
Time frame: The day after surgery (Day 1)
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 16 Apr 2025.
- Background: PubMed 16438017Pekcan M, Celebioglu B, Demir B, Saricaoglu F, Hascelik G, Yukselen MA, Basgul E, Aypar U. The effect of premedication on preoperative anxiety. Middle East J Anaesthesiol. 2005 Jun;18(2):421-33.
- Background: PubMed 1854034Shevde K, Panagopoulos G. A survey of 800 patients' knowledge, attitudes, and concerns regarding anesthesia. Anesth Analg. 1991 Aug;73(2):190-8. doi: 10.1213/00000539-199108000-00013.
- Background: PubMed 11207465Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. doi: 10.1034/j.1399-6576.2001.045003298.x.
- Background: PubMed 515298Miller SM. Coping with impending stress: psychophysiological and cognitive correlates of choice. Psychophysiology. 1979 Nov;16(6):572-81. doi: 10.1111/j.1469-8986.1979.tb01523.x. No abstract available.
- Background: PubMed 6886967Miller SM, Mangan CE. Interacting effects of information and coping style in adapting to gynecologic stress: should the doctor tell all? J Pers Soc Psychol. 1983 Jul;45(1):223-36. doi: 10.1037//0022-3514.45.1.223.
- Background: PubMed 10702461Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.
- Background: PubMed 8317718Jamison RN, Taft K, O'Hara JP, Ferrante FM. Psychosocial and pharmacologic predictors of satisfaction with intravenous patient-controlled analgesia. Anesth Analg. 1993 Jul;77(1):121-5.
- Background: PubMed 8939044Kulik JA, Mahler HI, Moore PJ. Social comparison and affiliation under threat: effects on recovery from major surgery. J Pers Soc Psychol. 1996 Nov;71(5):967-79. doi: 10.1037//0022-3514.71.5.967.
- Background: PubMed 1606095Munoz HR, Dagnino JA, Rufs JA, Bugedo GJ. Benzodiazepine premedication causes hypoxemia during spinal anesthesia in geriatric patients. Reg Anesth. 1992 May-Jun;17(3):139-42.
- Background: PubMed 12006794Agelink MW, Majewski TB, Andrich J, Mueck-Weymann M. Short-term effects of intravenous benzodiazepines on autonomic neurocardiac regulation in humans: a comparison between midazolam, diazepam, and lorazepam. Crit Care Med. 2002 May;30(5):997-1006. doi: 10.1097/00003246-200205000-00008.
- Background: PubMed 25734733Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.
- Background: PubMed 25101026Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.
- 2\. Amouroux R, Rousseau-Salvador C, Annequin D. L'anxiété préopératoire: manifestations cliniques, évaluation et prévention. Ann Méd-PsycholRevPsychiatr; 2010; 168:588-92Link provided by the sponsor.
- Servant D, Lebeau JC, Mouster Y et al. Cardiac variability, a good indicator of emotion regulation. Journal of cognitive behavioral therapy 2008; 18: 45-8.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
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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.
Jibba AMRAOUI, MD study chair
Institut régional du cancer de Montpellier
Régis FUZIER, MD principal investigator
Institut Universitaire du Cancer Toulouse - Oncopole
Lauriane Bordevane, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac coherence program coupled with hypnosis in people with Surgery and Oncology, run by Institut du Cancer de Montpellier - Val d'Aurelle at 4 sites 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 7 inclusion and 11 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 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Jean-Pierre BLEUSE, MD (4 67 61 31 02 ext. +33, jean-pierre.bleuse@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) of global anxiety (time frame: The morning of the surgery (Day 0) upon arrival in the operating room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05197972, which also lists 16 linked publications.
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 16 Apr 2025.