AplasiaHYPNONAGNCT05790733
HYPNONAG : Therapeutic Communication Versus Traditional Method for Naso-gastric Intubation in Haematology
A study testing Standard intubation and Hypnosis in people with Aplasia and Chemotherapy Effect, run by Rennes University Hospital at 2 sites in France.
Trial summary
Caloric intake is a determining factor in patients with hematological malignancies and hospitalized for prolonged aplasia following chemotherapy. The nutritional supplement is administered either parenterally or enterally through the placement of a nasogastric sonde (NGS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aplasia, Chemotherapy Effect
- What is being tested?
- Standard intubation and Hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jul 2024to 1 Aug 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient hospitalized for chemotherapy generating an aplasia lasting more than 8 days (hospitalization for 3 weeks) and for whom the insertion of an NGS is required and not yet attempted since admission to the hospital;
- Age ≥ 18 years;
- Affiliated to a social security scheme;
- Having signed a free, informed and written consent.
Who cannot join
- Pregnant or breastfeeding women;
- Patient who refuses NGS;
- Emergency surgery;
- Patients consuming long-term opiates before surgery;
- Substance addiction;
- Patient at the end of life and/or in palliative care;
Show all 10Show fewer
- Patient unable to answer a questionnaire and/or unable to understand the rating scales;
- Deaf and/or dumb patients;
- Patients with psychiatric pathologies (schizophrenia, bipolarity);
- Persons subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
Trial locations and contacts
2 sites in 1 country.
Thierry LAMY, MD contact
France2 sites, 2 recruiting
- Recruiting
Rennes University Hospital
Rennes, Brittany Region, 35033
Magali GRANGER, Nurse, 0299284321 ext. 87 290, magali.granger@chu-rennes.fr
Thierry LAMY, MD, thierry.lamy.de.la.chapelle@chu-rennes.fr
- Not yet recruiting
Tours University Hospital
Tours, 37000
Emmanuel Gyan, MD, e.gyan@chu-tours.fr
Olivia Werle, Nurse, o.werle@chu-tours.fr
About this study
Official title: HYPNONAG : Therapeutic Communication Versus Traditional Method for Naso-gastric Intubation in Haematology: Randomized Controlled Clinical Study
Caloric intake is a determining factor in patients with hematological malignancies and hospitalized for prolonged aplasia following chemotherapy. The nutritional supplement is administered either parenterally or enterally through the placement of a nasogastric sonde (NGS). This last option has shown its advantage compared to parenteral nutrition in terms of preventing infections, the incidence of graft-versus-host disease in allograft patients, and the quality of resumption of oral nutrition during of returning home.
NGS allows the administration of an intake of 2000 calories/day, deemed necessary to mitigate the risk of undernutrition in patients hospitalized for more than 3 weeks and in the majority of cases unable to eat enough food mainly due to chemotherapy-induced mucositis. . The choice between enteral feeding by NGS and parenteral nutrition is the subject of controversial studies, with each team choosing one of the two options.
Read more
The installation of the NGS is often recognized as a traumatic gesture for patients but also invasive by caregivers.
The patient's anxiety, the intrusive and traumatic nature of the NGS can sometimes result in a failure of the gesture, a secondary refusal of the patient, or a reluctance of the caregiver to proceed with the gesture. Since 2013, NGS have been placed with the assistance of the nurse who practices hypnosis in the hematology department of the Rennes University Hospital. This invites the patient to pose his SNG without local anesthesia and in a completely autonomous way. The patient is thus able to place the NGS again if necessary during his hospitalization, and during subsequent hospitalizations. A retrospective and monocentric study carried out at the University Hospital of Rennes in 38 patients showed that all were able to perform NGS independently thanks to the hypnotic approach. It was observed a real comfort for the patient, and moreover this technique did not add extra work for the staff. The patient becomes autonomous and actor of his care.
Read the detailed description
Strategy : Hypnosis versus standard way for the installation of an NGS. In the conventional arm, the nurse will place the NGS according to the recommendations of the French Health Authorities on the management of the induced pain. The patient is seated at 90 degrees. The nurse takes its landmarks on the NGS to be able to install the NGS at the correct landmark (it takes the SNG and measures "nose-ear, ear-stomach").
As part of this project, local anesthesia will be performed if the patient is part of the control arm and there will be none if he is part of the hypnosis arm.
When the patient will be randomized in the hypnosis arm, he will place his NGS himself with a hypnotic accompaniment, described in appendix.
This original project aims to evaluate the contribution of hypnosis in the installation of an NGS in patients hospitalized for the management of a malignant hemopathy for a period of at least 3 weeks. A group of patients will benefit from the autonomous installation of the NGS thanks to the assistance of a nurse hypnotherapist and will be compared to a group of patients for whom the NGS will be set up in a standard way. The main expected benefits of hypnosis for the patient include improved comfort and near absence of discomfort or pain during NGS placement, minimal anxiety and ultimately a benefit in terms of caloric intake administered during prolonged hospitalization.
- Conditions
- Aplasia, Chemotherapy Effect
- Being tested
- Standard intubation, Hypnosis
- Keywords
- Nasogastric intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard intubationOther
This involves the use of 5% Xylocaine nebulizer spray and a single-use cannula. The nurse checks its expiry date and that the quantity is sufficient to practice the 7 instillations in one nostril and the other 7 in the mouth. A waiting time is respected and the installation of the NGS can begin. She will also set up a fast for 2 hours after this local anesthesia.
HypnosisOther
Hypnosis is a particular psychological state marked by the functioning of the individual at a level of attention other than the ordinary state of consciousness. It can, under certain conditions, give the appearance of sleep or somnambulism without sharing all the characteristics.
As part of the treatment, hypnosis is widely used for pain control. The adverse effects reported are nil. One of its main benefits is improved patient comfort. Another benefit is the reduction of exposure to anesthetic products.
The installation of the NGS with hypnosis will be carried out according to the protocol set out in appendix 4.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | When the patient is in the conventional arm, the nurse of the service will place the NGS according to the recommendations of the French Health Authorities on the management of the induced pain. The patient is seated at 90 degrees. The nurse takes its landmarks on the NGS to be able to install the NGS at the correct landmark (it takes the NGS and measures "nose-ear, ear-stomach").
This arm involves the use of the 5% Xylocaine nebulizer spray and a single-use cannula.
The nurse checks its expiry date and that the quantity is sufficient to practice the 7 instillations in one nostril and the other 7 in the mouth. A waiting time is respected and the installation of the NGS can begin. She will also set up a fast for 2 hours after this local anesthesia. Receives: Other: Standard intubation |
| Hypnosis | Experimental | Hypnosis is a particular psychological state marked by the functioning of the individual at a level of attention other than the ordinary state of consciousness. It can, under certain conditions, give the appearance of sleep or somnambulism without sharing all the characteristics.
As part of the treatment, hypnosis is widely used for pain control. The adverse effects reported are nil. One of its main benefits is improved patient comfort. Another benefit is the reduction of exposure to anesthetic products.
The installation of the SNG with hypnosis will be carried out according to the protocol set out in appendix 4.
In the hypnosis arm, there will be none local anesthesia. Receives: Other: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Patient comfort will be assessed by a simple, validated digital comfort scale. This scale is graduated from "0" (no comfort) to "10" (maximum conceivable comfort). This evaluation will be carried within 3 minutes following the end of the intubation, i.e. after having checked the correct location of the probe thanks to the presence of air blown in by a syringe with a conical tip, that the nurse will check with a stethoscope right after securing the SNG with a hypoallergenic dressing on the patient's chee
Measured: Within 3 minutes after the end of the intubation
Secondary outcomes (8)
Pain visual analogue scale
The patient's pain will be assessed by the visual analogue scale (VAS). This scale is graduated from "0" (no pain) to "10" (maximum pain imaginable). It will be performed immediately after the assessment of the comfort scale.
Measured: Immediately after the assessment of the comfort scale (assessed within 3 minutes after the end of the intubation)
Anxiety
The anxiety felt by the patient will be assessed by a simple and validated numerical scale. This scale is graduated from "0" (no anxiety) to "10" (maximum anxiety imaginable). It will be performed 10 minutes (+/- 3 minutes) before the biopsy procedure and repeated after the biopsy procedure (just after the pain assessment).
Measured: 5 minutes (+/- 1 minute) before the NGS placement starts and repeated immediately after the procedure ends (just after the pain assessment)
Success or failure of the NGS placement according to the randomization arm
Success or failure of the NGS placement after using the method (standard method versus hypnosis) given by the randomization arm
Measured: During procedure
Number of failures
The number of failures during the first NGS insertion according to the randomization arm with the need to switch to another NGS insertion procedure, or even the need to switch to parenteral nutrition (following repeated failures of the NGS).
Measured: During procedure
Weight
Weight at entry and exit from hospitalization in the hematology department.
Measured: From date of admission to hospital in the hematology department up to date of the hospital discharge in the hematology department, assessed up to 3 months
Muscular strength
Muscular strength assessed by means of a dynamometer at entry and exit from hospitalization in the hematology department
Measured: From date of admission to hospital in the hematology department up to date of the hospital discharge in the hematology department, assessed up to 3 months
Total number of days of presence of the NGS
The total number of days of presence of the NGS during the hospitalization time
Measured: During the hospitalization time (up to 3 months)
Attempt or not of a new NGS intubation (in case of rejection of the first probe by vomiting)
In case of rejection of the first probe by vomiting during hospitalization, attempt or not of a new NGS intubation
Measured: From date of admission to hospital in the hematology department up to date of the hospital discharge in the hematology department, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Jul 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AplasiaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Prospective, randomized, bicentric, interventional study
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790733
- Sponsor's protocol ID
- 35RC22_9836_HYPNONAG
- Acronym
- HYPNONAG
- Status last verified
- Oct 2024
- First submitted
- 13 Feb 2023
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPNONAG : Therapeutic Communication Versus Traditional Method for Naso-gastric Intubation in Haematology: Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05790733
- Acronym / sponsor ID
- HYPNONAG / 35RC22_9836_HYPNONAG
- Conditions
- Aplasia, Chemotherapy Effect
- Keywords
- Nasogastric intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 30 Mar 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.
Caloric intake is a determining factor in patients with hematological malignancies and hospitalized for prolonged aplasia following chemotherapy. The nutritional supplement is administered either parenterally or enterally through the placement of a nasogastric sonde (NGS). This last option has shown its advantage compared to parenteral nutrition in terms of preventing infections, the incidence of graft-versus-host disease in allograft patients, and the quality of resumption of oral nutrition during of returning home.
NGS allows the administration of an intake of 2000 calories/day, deemed necessary to mitigate the risk of undernutrition in patients hospitalized for more than 3 weeks and in the majority of cases unable to eat enough food mainly due to chemotherapy-induced mucositis. . The choice between enteral feeding by NGS and parenteral nutrition is the subject of controversial studies, with each team choosing one of the two options.
The installation of the NGS is often recognized as a traumatic gesture for patients but also invasive by caregivers.
The patient's anxiety, the intrusive and traumatic nature of the NGS can sometimes result in a failure of the gesture, a secondary refusal of the patient, or a reluctance of the caregiver to proceed with the gesture. Since 2013, NGS have been placed with the assistance of the nurse who practices hypnosis in the hematology department of the Rennes University Hospital. This invites the patient to pose his SNG without local anesthesia and in a completely autonomous way. The patient is thus able to place the NGS again if necessary during his hospitalization, and during subsequent hospitalizations. A retrospective and monocentric study carried out at the University Hospital of Rennes in 38 patients showed that all were able to perform NGS independently thanks to the hypnotic approach. It was observed a real comfort for the patient, and moreover this technique did not add extra work for the staff. The patient becomes autonomous and actor of his care.
Detailed description
Strategy : Hypnosis versus standard way for the installation of an NGS. In the conventional arm, the nurse will place the NGS according to the recommendations of the French Health Authorities on the management of the induced pain. The patient is seated at 90 degrees. The nurse takes its landmarks on the NGS to be able to install the NGS at the correct landmark (it takes the SNG and measures "nose-ear, ear-stomach").
As part of this project, local anesthesia will be performed if the patient is part of the control arm and there will be none if he is part of the hypnosis arm.
When the patient will be randomized in the hypnosis arm, he will place his NGS himself with a hypnotic accompaniment, described in appendix.
This original project aims to evaluate the contribution of hypnosis in the installation of an NGS in patients hospitalized for the management of a malignant hemopathy for a period of at least 3 weeks. A group of patients will benefit from the autonomous installation of the NGS thanks to the assistance of a nurse hypnotherapist and will be compared to a group of patients for whom the NGS will be set up in a standard way. The main expected benefits of hypnosis for the patient include improved comfort and near absence of discomfort or pain during NGS placement, minimal anxiety and ultimately a benefit in terms of caloric intake administered during prolonged hospitalization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, bicentric, interventional study
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Other: Standard intubationWhen the patient is in the conventional arm, the nurse of the service will place the NGS according to the recommendations of the French Health Authorities on the management of the induced pain. The patient is seated at 90 degrees. The nurse takes its landmarks on the NGS to be able to install the NGS at the correct landmark (it takes the NGS and measures "nose-ear, ear-stomach"). This arm involves the use of the 5% Xylocaine nebulizer spray and a single-use cannula. The nurse checks its expiry date and that the quantity is sufficient to practice the 7 instillations in one nostril and the other 7 in the mouth. A waiting time is respected and the installation of the NGS can begin. She will also set up a fast for 2 hours after this local anesthesia. |
| Hypnosis | Experimental | Other: HypnosisHypnosis is a particular psychological state marked by the functioning of the individual at a level of attention other than the ordinary state of consciousness. It can, under certain conditions, give the appearance of sleep or somnambulism without sharing all the characteristics. As part of the treatment, hypnosis is widely used for pain control. The adverse effects reported are nil. One of its main benefits is improved patient comfort. Another benefit is the reduction of exposure to anesthetic products. The installation of the SNG with hypnosis will be carried out according to the protocol set out in appendix 4. In the hypnosis arm, there will be none local anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient hospitalized for chemotherapy generating an aplasia lasting more than 8 days (hospitalization for 3 weeks) and for whom the insertion of an NGS is required and not yet attempted since admission to the hospital;
- Age ≥ 18 years;
- Affiliated to a social security scheme;
- Having signed a free, informed and written consent.
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women;
- Patient who refuses NGS;
- Emergency surgery;
- Patients consuming long-term opiates before surgery;
- Substance addiction;
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 |
|---|---|---|
| Standard intubationThis involves the use of 5% Xylocaine nebulizer spray and a single-use cannula. The nurse checks its expiry date and that the quantity is sufficient to practice the 7 instillations in one nostril and the other 7 in the mouth. A waiting time is respected and the installation of the NGS can begin. She will also set up a fast for 2 hours after this local anesthesia. | Other | Standard |
| HypnosisHypnosis is a particular psychological state marked by the functioning of the individual at a level of attention other than the ordinary state of consciousness. It can, under certain conditions, give the appearance of sleep or somnambulism without sharing all the characteristics. As part of the treatment, hypnosis is widely used for pain control. The adverse effects reported are nil. One of its main benefits is improved patient comfort. Another benefit is the reduction of exposure to anesthetic products. The installation of the NGS with hypnosis will be carried out according to the protocol set out in appendix 4. | Other | Hypnosis |
Primary outcome
Comfort
Time frame: Within 3 minutes after the end of the intubation
Patient comfort will be assessed by a simple, validated digital comfort scale. This scale is graduated from "0" (no comfort) to "10" (maximum conceivable comfort). This evaluation will be carried within 3 minutes following the end of the intubation, i.e. after having checked the correct location of the probe thanks to the presence of air blown in by a syringe with a conical tip, that the nurse will check with a stethoscope right after securing the SNG with a hypoallergenic dressing on the patient's chee
8 secondary outcomes
Pain visual analogue scale
Time frame: Immediately after the assessment of the comfort scale (assessed within 3 minutes after the end of the intubation)
Anxiety
Time frame: 5 minutes (+/- 1 minute) before the NGS placement starts and repeated immediately after the procedure ends (just after the pain assessment)
Success or failure of the NGS placement according to the randomization arm
Time frame: During procedure
Number of failures
Time frame: During procedure
Weight
Time frame: From date of admission to hospital in the hematology department up to date of the hospital discharge in the hematology department, assessed up to 3 months
Muscular strength
Time frame: From date of admission to hospital in the hematology department up to date of the hospital discharge in the hematology department, assessed up to 3 months
Total number of days of presence of the NGS
Time frame: During the hospitalization time (up to 3 months)
Attempt or not of a new NGS intubation (in case of rejection of the first probe by vomiting)
Time frame: From date of admission to hospital in the hematology department up to date of the hospital discharge in the hematology department, assessed up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- 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. This study is not recruiting at the moment.
Thierry LAMY, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard intubation and Hypnosis in people with Aplasia and Chemotherapy Effect, run by Rennes University Hospital at 2 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 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: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magali GRANGER, nurse (02 99 28 43 21 ext. 87290, magali.granger@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort (time frame: Within 3 minutes after the end of the intubation). 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 9 Oct 2024.