Clinical trial NCT05790733: HYPNONAG : Therapeutic Communication Versus Traditional Method for Naso-gastric Intubation in Haematology
Official title: HYPNONAG : Therapeutic Communication Versus Traditional Method for Naso-gastric Intubation in Haematology: Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aplasia
Chemotherapy Effect
Keywords: Nasogastric intubation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, bicentric, interventional study
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Comfort
timeFrame: Within 3 minutes after the end of the intubation
Secondary outcomes:
measure: Pain visual analogue scale
timeFrame: Immediately after the assessment of the comfort scale (assessed within 3 minutes after the end of the intubation)
measure: Anxiety
timeFrame: 5 minutes (+/- 1 minute) before the NGS placement starts and repeated immediately after the procedure ends (just after the pain assessment)
measure: Success or failure of the NGS placement according to the randomization arm
timeFrame: During procedure
measure: Number of failures
timeFrame: During procedure
measure: Weight
timeFrame: 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
measure: Muscular strength
timeFrame: 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
measure: Total number of days of presence of the NGS
timeFrame: During the hospitalization time (up to 3 months)
measure: Attempt or not of a new NGS intubation (in case of rejection of the first probe by vomiting)
timeFrame: 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
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Bretagne
city: Tours
country: France
facility: Tours University Hospital
Study officials:
References: