Breast CancerCOHECNCT03981731
Management of Perioperative Anxiety by the Cardiac Coherence Technique Coupled With a Hypnosis Session
A study testing Cardiac coherence in people with Breast Cancer and Gynecologic Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
the investigator proposes to use the cardiac coherence technique coupled with a hypnosis session to improve post-operative recovery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer
- What is being tested?
- Cardiac coherence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2020to 14 Jan 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Surgery for breast or gynaecological cancer requiring scheduled hospitalization for up to 3 days
- Signing of informed consent before any specific procedure in the study
- Patient affiliated to a social security system
Who cannot join
- Patients undergoing outpatient surgery for their cancer will not be included
- Natural bradycardia (50 beats per minute)
- Patient taking β-blockers, digoxin, flecaine, isoptin, cordarone, diltiazem
- Cardiac arrhythmias
- Severe heart failure with ventricular ejection fraction < 40%
- Uncontrolled chronic pain
Show all 10Show fewer
- Patients whose medical or psychological conditions do not allow them to complete the study or sign the consent
- Patient does not understand the French language
- Deaf and/or dumb patient
- Adult patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Institut régional du cancer de Montpellier
Montpellier, Hérault, 34298
About this study
Official title: Management of Perioperative Anxiety by the Fixed Rate Guided Breathing Technique (Cardiac Coherence) Coupled With a Hypnosis Session, as Part of the Improved Pre-habilitation After Surgery
the investigator proposes to use the cardiac coherence technique coupled with a hypnosis session to improve post-operative recovery.
Read the detailed description
The perioperative period is recognized as an anxiety-provoking period for patients. If for some patients, this anxiety is more or less manageable, for others, it is the major concern with regard to their intervention, fearing not to wake up, to remain in a coma. Consideration of this aspect is very important for patients who require surgery. It is also a concern for caregivers involved in the care of these patients, including anesthesiologists, surgeons and operating room staff.
For many years, pharmacological premedication, including benzodiazepines, has been the gold standard in the treatment of preoperative anxiety.
This systematic prescription is controversial in populations most exposed to side effects such as the elderly, patients with heart or respiratory diseases.
Surgery also seems to influence the impact of premedication. For example, abdominal surgery and breast surgery are associated with a higher risk of agitation upon awakening.
Mental preparation, based on simple explanations by the anaesthetist, is not enough to reduce patients' anxiety.
A recent study evaluated the perioperative experience of patients receiving or not receiving premedication. It shows that benzodiazepines are associated with cognitive impairment and delayed extubation in the elderly. In addition, it seems to have little effect on patient anxiety when compared to a placebo.
In this context of anxiety, an emotional regulation tool appears particularly relevant. Cardiac coherence" (CC) is a particular state of cardiac variability. This state is correlated with many physiological and psychological variables. It is possible to promote this state through different techniques. One of its practices, "fixed frequency guided breathing", seems relevant both in its principles and in its simplicity of implementation.
This specific respiratory mode permits to rebalance the sympathetic - parasympathetic balance of the autonomic nervous system and reveals a state of calm vigilance. This simple, well-coded respiratory psychophysiological practice is widely used in many applications, such as for the most caricatural ones, the management of difficult situations where stress is a central element such as decision-making among fighter pilots on mission, in national education to improve academic learning (especially among anxious students) and also more generally in stress and anxiety management.
This technique induces a refocusing of emotions by regulating the SNA and therefore a better regulation of the hormones involved in the emotional cascade.
This practice has several advantages:
- it is psychophysiological (psychocorporeal) and widely described in the scientific literature in several indications
- it is completely free of charge and immediately accessible to the patient, regardless of time and place
- it can be used at other anxiety-inducing times (e.g., imaging or biopsy tests)
- it allows total patient autonomy, offering self-management of anxiety and independence from the presence of a third party
- it can approach a hypnotic model by focusing and absorbing what it can induce on breathing, and thus share some of its benefits
- It does not have any adverse effects. The major difficulty of this technique is the adherence and regularity of the practice. The optimal effect is dependent on regular training.
To improve this adherence, an audio tape will be put online, read in a hypnotic tone, which will aim to explain respiratory physiology, the benefits of oxygenation on cells and metabolism; this will have the effect of understanding the interest and utility of this exercise and will contribute to induce a feeling of relaxation and well-being.
This study will be a study of feasibility about a program based on the cardiac coherence technique in a context of perioperative anxiety.
- Conditions
- Breast Cancer, Gynecologic Cancer
- Being tested
- Cardiac coherence
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac coherenceOther
An initiation session to cardiac coherence will take place between D-10 and D-7 before the operation (during the anaesthesia consultation) in order to obtain a breathing rate of 6 cycles/min via a free application (Respirelax) with listening to an audio tape.
3 cardiac coherence sessions per day of 5 min (before meals) during the 7 days preceding the operation.
- The anaesthetic induction will be done with a session of cardiac coherence associated with listening to the audio tape.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac coherence | Experimental | Not described Receives: Other: Cardiac coherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who have enrolled in the pre-habilitation program
A patient will be considered to have optimally adhered to the program if she performs at least 2/3 of the proposed cardiac coherence sessions (that represents 67% of the total number of sessions), that is, at least 14 sessions over the 7 days preceding the surgery.
Measured: 7 days
Secondary outcomes (18)
The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
The anxiety scale consists of six items, each of which could be scored from 1 to 5 with the end poles "not at all" (1) and "extremely" (5). The score of the anxiety scale is the sum of these four questions, with a scoring range from 6 to 30.
Measured: 7 days
Patient's satisfaction with perioperative period by using "Evaluation of the Vecu of General Anesthesia" questionnaire (EVAN-G)
The validated 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 (average of all scores). For each of the scores: the higher the score, the higher the satisfaction. For each dimension, scores were reduced on a scale from 0 to 100. The higher the score, the higher the perceived quality of the experience. The total score was the sum of the scores of the six dimensions reduced to 100.
Measured: 48 hours
Measurement of the Postoperative Quality of Recovery (QoR)
The quality of postoperative functional recovery will be assessed by the QoR-15 questionnaire, which 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 on the QoR-15 ranges from 0 (poorest quality of recovery) to 150 (best quality of recovery).
Measured: 10 days
Measurement of anxiety level by using a visual analogue scale
It's a visual scale from 0 (no anxiety) to 100 (highest anxiety)
Measured: 7 days
Measurement of wake-up quality by using a visual analogue scale
It's a visual scale from 0 (best wake-up) to 100 (worst wake-up)
Measured: 1 day
Measurement of post-operative pain by using a visual analogue scale
It's a visual scale from 0 (no pain) to 100 (highest pain)
Measured: 1 day
Measurement of post-operative fatigue by using a visual analogue scale
It's a visual scale from 0 (no fatigue) to 100 (highest fatigue)
Measured: 1 day
Measurement of comfort and satisfaction with care by using a visual analogue scale
It's a visual scale from 0 (ideal care) to 100 worst care)
Measured: 1 day
Number of patients taking anesthetic drugs at induction of anaesthesia
Measured: 1 day
Number of patients taking anesthetic drugs during the post-interventional monitoring
Measured: 1 day
Number of patients taking morphine in recovery room
Measured: 1 day
Number of patients taking setrons (nausea and vomiting medication)
Measured: 1 day
Rate of patients that consider continuing the program of cardiac coherence
Measured: 1 day
Rate of patients willing to recommend the technique
Measured: 1 day
Number of days of hospitalization
Measured: 1 month
Number of patients taking morphine in peroperative
Measured: 1 day
Measurement of pain at inclusion by using a visual analogue scale
It's a visual scale from 0 (no pain) to 100 (highest pain)
Measured: 1 day
The recruitment rate (proportion of patients consenting to participate in the study among eligible patients at the screening) and reasons for refusal.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start14 Feb 2020
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jibba AMRAOUI, MD, Study chair, Institut régional du cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981731
- Sponsor's protocol ID
- PROICM 2019-06 COH
- Acronym
- COHEC
- Status last verified
- Feb 2026
- First submitted
- 7 Jun 2019
- Last updated
- 5 Feb 2026
- 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 disidentified participants' data, the study protocol, the statistical analysis plan, the clinical study report and the analytic code. 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 16438017Van den Bosch JE, Moons KG, Bonsel GJ, Kalkman CJ. Does measurement of preoperative anxiety have added value for predicting postoperative nausea and vomiting? Anesth Analg. 2005 May;100(5):1525-1532. doi: 10.1213/01.ANE.0000149325.20542.D4.
PubMed 15845719Munoz 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 12006794Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2.
PubMed 16670111McCraty 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, Leclerc G, Jarlier M, Diaz J, Guler R, Demoly C, Verin C, Rey Dit Guzer S, Chalbos P, Moussion A, Taoum C, Neron M, Philibert L. Cardiac coherence and medical hypnosis: a feasibility study of a new combined approach for managing preoperative anxiety in patients with breast or gynaecological cancer. BJA Open. 2024 Sep 24;12:100309. doi: 10.1016/j.bjao.2024.100309. eCollection 2024 Dec.
PubMed 39381542
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Perioperative Anxiety by the Fixed Rate Guided Breathing Technique (Cardiac Coherence) Coupled With a Hypnosis Session, as Part of the Improved Pre-habilitation After Surgery
- ClinicalTrials.gov ID
- NCT03981731
- Acronym / sponsor ID
- COHEC / PROICM 2019-06 COH
- Conditions
- Breast Cancer, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 11 Jun 2019 (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 coupled with a hypnosis session to improve post-operative recovery.
Detailed description
The perioperative period is recognized as an anxiety-provoking period for patients. If for some patients, this anxiety is more or less manageable, for others, it is the major concern with regard to their intervention, fearing not to wake up, to remain in a coma. Consideration of this aspect is very important for patients who require surgery. It is also a concern for caregivers involved in the care of these patients, including anesthesiologists, surgeons and operating room staff.
For many years, pharmacological premedication, including benzodiazepines, has been the gold standard in the treatment of preoperative anxiety.
This systematic prescription is controversial in populations most exposed to side effects such as the elderly, patients with heart or respiratory diseases.
Surgery also seems to influence the impact of premedication. For example, abdominal surgery and breast surgery are associated with a higher risk of agitation upon awakening.
Mental preparation, based on simple explanations by the anaesthetist, is not enough to reduce patients' anxiety.
A recent study evaluated the perioperative experience of patients receiving or not receiving premedication. It shows that benzodiazepines are associated with cognitive impairment and delayed extubation in the elderly. In addition, it seems to have little effect on patient anxiety when compared to a placebo.
In this context of anxiety, an emotional regulation tool appears particularly relevant. Cardiac coherence" (CC) is a particular state of cardiac variability. This state is correlated with many physiological and psychological variables. It is possible to promote this state through different techniques. One of its practices, "fixed frequency guided breathing", seems relevant both in its principles and in its simplicity of implementation.
This specific respiratory mode permits to rebalance the sympathetic - parasympathetic balance of the autonomic nervous system and reveals a state of calm vigilance. This simple, well-coded respiratory psychophysiological practice is widely used in many applications, such as for the most caricatural ones, the management of difficult situations where stress is a central element such as decision-making among fighter pilots on mission, in national education to improve academic learning (especially among anxious students) and also more generally in stress and anxiety management.
This technique induces a refocusing of emotions by regulating the SNA and therefore a better regulation of the hormones involved in the emotional cascade.
This practice has several advantages:
- it is psychophysiological (psychocorporeal) and widely described in the scientific literature in several indications
- it is completely free of charge and immediately accessible to the patient, regardless of time and place
- it can be used at other anxiety-inducing times (e.g., imaging or biopsy tests)
- it allows total patient autonomy, offering self-management of anxiety and independence from the presence of a third party
- it can approach a hypnotic model by focusing and absorbing what it can induce on breathing, and thus share some of its benefits
- It does not have any adverse effects. The major difficulty of this technique is the adherence and regularity of the practice. The optimal effect is dependent on regular training.
To improve this adherence, an audio tape will be put online, read in a hypnotic tone, which will aim to explain respiratory physiology, the benefits of oxygenation on cells and metabolism; this will have the effect of understanding the interest and utility of this exercise and will contribute to induce a feeling of relaxation and well-being.
This study will be a study of feasibility about a program based on the cardiac coherence technique in a context of perioperative anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac coherence | Experimental | Other: Cardiac coherence |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Surgery for breast or gynaecological cancer requiring scheduled hospitalization for up to 3 days
- Signing of informed consent before any specific procedure in the study
- Patient affiliated to a social security system
Key exclusion criteria (10 listed)
- Patients undergoing outpatient surgery for their cancer will not be included
- Natural bradycardia (50 beats per minute)
- Patient taking β-blockers, digoxin, flecaine, isoptin, cordarone, diltiazem
- Cardiac arrhythmias
- 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 coherenceAn initiation session to cardiac coherence will take place between D-10 and D-7 before the operation (during the anaesthesia consultation) in order to obtain a breathing rate of 6 cycles/min via a free application (Respirelax) with listening to an audio tape. 3 cardiac coherence sessions per day of 5 min (before meals) during the 7 days preceding the operation. - The anaesthetic induction will be done with a session of cardiac coherence associated with listening to the audio tape. | Other | Cardiac coherence |
Primary outcome
Proportion of patients who have enrolled in the pre-habilitation program
Time frame: 7 days
A patient will be considered to have optimally adhered to the program if she performs at least 2/3 of the proposed cardiac coherence sessions (that represents 67% of the total number of sessions), that is, at least 14 sessions over the 7 days preceding the surgery.
18 secondary outcomes
The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: 7 days
Patient's satisfaction with perioperative period by using "Evaluation of the Vecu of General Anesthesia" questionnaire (EVAN-G)
Time frame: 48 hours
Measurement of the Postoperative Quality of Recovery (QoR)
Time frame: 10 days
Measurement of anxiety level by using a visual analogue scale
Time frame: 7 days
Measurement of wake-up quality by using a visual analogue scale
Time frame: 1 day
Measurement of post-operative pain by using a visual analogue scale
Time frame: 1 day
Measurement of post-operative fatigue by using a visual analogue scale
Time frame: 1 day
Measurement of comfort and satisfaction with care by using a visual analogue scale
Time frame: 1 day
Number of patients taking anesthetic drugs at induction of anaesthesia
Time frame: 1 day
Number of patients taking anesthetic drugs during the post-interventional monitoring
Time frame: 1 day
Number of patients taking morphine in recovery room
Time frame: 1 day
Number of patients taking setrons (nausea and vomiting medication)
Time frame: 1 day
Rate of patients that consider continuing the program of cardiac coherence
Time frame: 1 day
Rate of patients willing to recommend the technique
Time frame: 1 day
Number of days of hospitalization
Time frame: 1 month
Number of patients taking morphine in peroperative
Time frame: 1 day
Measurement of pain at inclusion by using a visual analogue scale
Time frame: 1 day
The recruitment rate (proportion of patients consenting to participate in the study among eligible patients at the screening) and reasons for refusal.
Time frame: 1 day
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 5 Feb 2026.
- 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 15845719Van den Bosch JE, Moons KG, Bonsel GJ, Kalkman CJ. Does measurement of preoperative anxiety have added value for predicting postoperative nausea and vomiting? Anesth Analg. 2005 May;100(5):1525-1532. doi: 10.1213/01.ANE.0000149325.20542.D4.
- 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 16670111Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2.
- Background: PubMed 7484873McCraty 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.
- Results publication: PubMed 39381542Amraoui J, Leclerc G, Jarlier M, Diaz J, Guler R, Demoly C, Verin C, Rey Dit Guzer S, Chalbos P, Moussion A, Taoum C, Neron M, Philibert L. Cardiac coherence and medical hypnosis: a feasibility study of a new combined approach for managing preoperative anxiety in patients with breast or gynaecological cancer. BJA Open. 2024 Sep 24;12:100309. doi: 10.1016/j.bjao.2024.100309. eCollection 2024 Dec.
- 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 disidentified participants' data, the study protocol, the statistical analysis plan, the clinical study report and the analytic code. 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. This study is not recruiting at the moment.
Jibba AMRAOUI, MD study chair
Institut régional du cancer de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac coherence in people with Breast Cancer and Gynecologic Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 4 inclusion and 10 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 5 Feb 2026. 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?
Proportion of patients who have enrolled in the pre-habilitation program (time frame: 7 days). 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 NCT03981731, which also lists 7 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 5 Feb 2026.