CancerHYPNO-AROMANCT05714995
Evaluation of the Therapeutic Approach of Aromatherapy by Olfaction of Essential Oils in Association With Hypnosis in the Management of Patients Followed for Cancer
An observational study of Cancer, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Patients having the following gestures (blood test, change of dressing for cancerous lesion and complete toilet in bed) will be identified by the team of the medical oncology department. During the first contact (V0), the study will be presented to the patients in order to obtain their consent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- hypnosis and Hypnosis with aromatherapy
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2024to 10 Oct 2026
- 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: Patients coming to HDJ or hospitalized in a conventional medical oncology unit, monitored from the 1st line of chemotherapy and taken care of by the mobile palliative care support team (EMASP)
Who may be able to join
- Patients aged ≥18 years
- Patients followed in medical oncology and by the mobile palliative care support team
- From the first line of chemotherapy
- Patient requiring one of the following procedures:
- Blood samples via a central catheter with a percutaneous implantable chamber, with a Huber needle
- Peripheral venous samples
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- Change of dressing for cancerous lesion
- Complete toilet in bed
- Patients who have given their consent
- Patient affiliated with a social security scheme
Who cannot join
- Protected person under guardianship or curatorship,
- Person deprived of liberty
- Person unable to express consent
- Pregnant woman and breastfeeding woman
- History of allergy or intolerance to essential oils
- Patients with cognitive or language disorders that make it impossible to answer the questionnaires
- Psychotic disorders
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
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Lambert Vadrot, 0157022675, lambert.vadrot@chicreteil.fr
About this study
Official title: Evaluation of the Therapeutic Approach of Aromatherapy by Olfaction of Essential Oils in Association With Hypnosis in the Care of Patients Followed in Oncology for Cancer Within a Mobile Palliative Care Support Team (EMASP)
Patients having the following gestures (blood test, change of dressing for cancerous lesion and complete toilet in bed) will be identified by the team of the medical oncology department.
During the first contact (V0), the study will be presented to the patients in order to obtain their consent. Anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.1). The gesture will then be performed and the patient's comfort will be evaluated after the gesture is performed in order to obtain the starting data for the study.
Read more
Patients will be reviewed in consultation according to the time recommended for each type of gesture.
During the second contact V1 (between 1 and 9 days after D0) anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.2). Patients will then be randomized. After randomization, the first hypnosis session will be performed at the same time as gesture No. 2 and the patient's comfort will be evaluated after the gesture is performed. The patient will receive the self-hypnosis training on the same day.
A period of 7 ± 2 days will be considered for the learning time of self-hypnosis.
The third contact will take place on day D7+/-2 after V1. During this visit, anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.3). Gesture No.3 will be carried out under the effect of self-hypnosis ± aromatherapy and the measurement of comfort will be carried out immediately afterwards
Read the detailed description
Include (V0):
Patients in whom the following procedures must be performed:
- Blood samples via a central catheter with a percutaneous implantable chamber, with a Huber needle
- Peripheral venous samples
- Tumor Lesion Dressing
- Complete toilet in bed will be identified by the team of the medical oncology department. During the first contact (V0), the study will be presented to the patients in order to obtain their consent. After signing the consent and before performing the gesture causing discomfort (gesture No.1), anxiety and well-being will be assessed by the verbal administration of the ESAS scale. The gesture will then be performed and the patient's comfort will be assessed using the ESAS scale after the gesture has been performed in order to obtain the data at the start of the study. An appointment for the V1 visit (between 1 and 9 days after D0) will be set for the next procedure.
First V1 hypnosis session (between 1 and 9 days after D0):
During the second contact at visit V1 (between 1 and 9 days after D0), anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.2). Randomization will take place immediately before performing the procedure. After randomization, the first session of hypnosis +/- aromatherapy will be performed at the same time as gesture No. 2 and the patient's comfort will be evaluated after the gesture is performed. During this hypnosis session, the patient will receive self-hypnosis training according to the group they belong to (self-hypnosis vs self-hypnosis + aromatherapy). An appointment for the realization of the next gesture (gesture No.3) will be set for D7 (+/- 2 days after V1). This period of time (7±2 days) will be considered the learning time for self-hypnosis.
Second V2 hypnosis session (D7+-/ 2 days after V1):
The third contact V2 will take place at (D7+/- 2 days after V1). During this visit, anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.3). Gesture No.3 will be carried out under the effect of self-hypnosis ± aromatherapy and the measurement of comfort will be carried out immediately afterwards.
- Conditions
- Cancer
- Being tested
- hypnosis, Hypnosis with aromatherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosisOther
The hypnosis session involves the following steps:
- Preparation for the activation of the hypnotic trance
- Activation of the hypnotic trance
- Deepening the hypnotic trance
- Maintaining hypnotic trance
- Coming out of the hypnotic trance
Hypnosis with aromatherapyOther
for patients in the hypnosis with aromatherapy group, before starting the hypnosis session, they will first choose an essential oil among the 5 proposed.
They will pour a drop on their wrist then they will rub it and inhale deeply.
The hypnosis session involves the following steps:
- Preparation for the activation of the hypnotic trance
- Activation of the hypnotic trance
- Deepening the hypnotic trance
- Maintaining hypnotic trance
- Coming out of the hypnotic trance
| Study group | Role | What they receive |
|---|---|---|
| hypnosis | patients in the hypnosis group will perform self-hypnosis sessions Receives: Other: hypnosis | |
| hypnosis with aromatherapy | patients in the hypnosis with aromatherapy group will perform self-hypnosis sessions with inhalation of an essential oil Receives: Other: Hypnosis with aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in comfort score between the two groups: The comfort score will be evaluated by the French version of the pain scale of the Edmonton Symptom Assessment System
The comfort score will be evaluated by the French version of the pain scale of the Edmonton Symptom Assessment System. The severity of each symptom was rated from 0 to 10 (0 = no symptom, 10 = worst possible intensity
Measured: betwen the baseline and day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start10 Apr 2024
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714995
- Sponsor's protocol ID
- HYPNO-AROMA
- Acronym
- HYPNO-AROMA
- Status last verified
- Jun 2025
- First submitted
- 12 Jan 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Approach of Aromatherapy by Olfaction of Essential Oils in Association With Hypnosis in the Care of Patients Followed in Oncology for Cancer Within a Mobile Palliative Care Support Team (EMASP)
- ClinicalTrials.gov ID
- NCT05714995
- Acronym / sponsor ID
- HYPNO-AROMA / HYPNO-AROMA
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 6 Feb 2023 (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.
Patients having the following gestures (blood test, change of dressing for cancerous lesion and complete toilet in bed) will be identified by the team of the medical oncology department.
During the first contact (V0), the study will be presented to the patients in order to obtain their consent. Anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.1). The gesture will then be performed and the patient's comfort will be evaluated after the gesture is performed in order to obtain the starting data for the study.
Patients will be reviewed in consultation according to the time recommended for each type of gesture.
During the second contact V1 (between 1 and 9 days after D0) anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.2). Patients will then be randomized. After randomization, the first hypnosis session will be performed at the same time as gesture No. 2 and the patient's comfort will be evaluated after the gesture is performed. The patient will receive the self-hypnosis training on the same day.
A period of 7 ± 2 days will be considered for the learning time of self-hypnosis.
The third contact will take place on day D7+/-2 after V1. During this visit, anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.3). Gesture No.3 will be carried out under the effect of self-hypnosis ± aromatherapy and the measurement of comfort will be carried out immediately afterwards
Detailed description
Include (V0):
Patients in whom the following procedures must be performed:
- Blood samples via a central catheter with a percutaneous implantable chamber, with a Huber needle
- Peripheral venous samples
- Tumor Lesion Dressing
- Complete toilet in bed will be identified by the team of the medical oncology department. During the first contact (V0), the study will be presented to the patients in order to obtain their consent. After signing the consent and before performing the gesture causing discomfort (gesture No.1), anxiety and well-being will be assessed by the verbal administration of the ESAS scale. The gesture will then be performed and the patient's comfort will be assessed using the ESAS scale after the gesture has been performed in order to obtain the data at the start of the study. An appointment for the V1 visit (between 1 and 9 days after D0) will be set for the next procedure.
First V1 hypnosis session (between 1 and 9 days after D0):
During the second contact at visit V1 (between 1 and 9 days after D0), anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.2). Randomization will take place immediately before performing the procedure. After randomization, the first session of hypnosis +/- aromatherapy will be performed at the same time as gesture No. 2 and the patient's comfort will be evaluated after the gesture is performed. During this hypnosis session, the patient will receive self-hypnosis training according to the group they belong to (self-hypnosis vs self-hypnosis + aromatherapy). An appointment for the realization of the next gesture (gesture No.3) will be set for D7 (+/- 2 days after V1). This period of time (7±2 days) will be considered the learning time for self-hypnosis.
Second V2 hypnosis session (D7+-/ 2 days after V1):
The third contact V2 will take place at (D7+/- 2 days after V1). During this visit, anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.3). Gesture No.3 will be carried out under the effect of self-hypnosis ± aromatherapy and the measurement of comfort will be carried out immediately afterwards.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypnosis | – | Other: hypnosispatients in the hypnosis group will perform self-hypnosis sessions |
| hypnosis with aromatherapy | – | Other: Hypnosis with aromatherapypatients in the hypnosis with aromatherapy group will perform self-hypnosis sessions with inhalation of an essential oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients coming to HDJ or hospitalized in a conventional medical oncology unit, monitored from the 1st line of chemotherapy and taken care of by the mobile palliative care support team (EMASP)
Key inclusion criteria (10 listed)
- Patients aged ≥18 years
- Patients followed in medical oncology and by the mobile palliative care support team
- From the first line of chemotherapy
- Patient requiring one of the following procedures:
- Blood samples via a central catheter with a percutaneous implantable chamber, with a Huber needle
Key exclusion criteria (7 listed)
- Protected person under guardianship or curatorship,
- Person deprived of liberty
- Person unable to express consent
- Pregnant woman and breastfeeding woman
- History of allergy or intolerance to essential oils
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 |
|---|---|---|
| hypnosisThe hypnosis session involves the following steps: 1. Preparation for the activation of the hypnotic trance 2. Activation of the hypnotic trance 3. Deepening the hypnotic trance 4. Maintaining hypnotic trance 5. Coming out of the hypnotic trance | Other | hypnosis |
| Hypnosis with aromatherapyfor patients in the hypnosis with aromatherapy group, before starting the hypnosis session, they will first choose an essential oil among the 5 proposed. They will pour a drop on their wrist then they will rub it and inhale deeply. The hypnosis session involves the following steps: 1. Preparation for the activation of the hypnotic trance 2. Activation of the hypnotic trance 3. Deepening the hypnotic trance 4. Maintaining hypnotic trance 5. Coming out of the hypnotic trance | Other | hypnosis with aromatherapy |
Primary outcome
difference in comfort score between the two groups: The comfort score will be evaluated by the French version of the pain scale of the Edmonton Symptom Assessment System
Time frame: betwen the baseline and day 17
The comfort score will be evaluated by the French version of the pain scale of the Edmonton Symptom Assessment System. The severity of each symptom was rated from 0 to 10 (0 = no symptom, 10 = worst possible intensity
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 11 Mar 2026.
- 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 Cancer, run by Centre Hospitalier Intercommunal Creteil 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 10 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 11 Mar 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?
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 Lambert VADROT (0157022675, lambert.vadrot@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in comfort score between the two groups: The comfort score will be evaluated by the French version of the pain scale of the Edmonton Symptom Assessment System (time frame: betwen the baseline and day 17). 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 11 Mar 2026.