An interventional study of Standard intubation and Hypnosis in Aplasia and Chemotherapy Effect, sponsored by Rennes University Hospital. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Supportive care
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.
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.
Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
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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.
Other: Standard intubation
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.
Other: Hypnosis
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.
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.
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
Time frame: Within 3 minutes after the end of the intubation
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.
Time frame: 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).
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
Success or failure of the NGS placement after using the method (standard method versus hypnosis) given by the randomization arm
Time frame: 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).
Time frame: During procedure
Weight
Weight at entry and exit from hospitalization in the hematology department.
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
Muscular strength assessed by means of a dynamometer at entry and exit from hospitalization in the hematology department
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
The total number of days of presence of the NGS during the hospitalization time
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)
In case of rejection of the first probe by vomiting during hospitalization, attempt or not of a new NGS intubation
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
Plan to share: No
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Started Jul 2024 (actual). Primary completion is estimated for Feb 2026, 19 months after the start.
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