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Recruiting Not applicable

HYPNONAG : Therapeutic Communication Versus Traditional Method for Naso-gastric Intubation in Haematology

NCT05790733 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-07-01
Last updated
2024-10-09

Condition(s) studied

AplasiaChemotherapy Effect

Investigational drug(s) / intervention(s)

Standard intubationHypnosis

Standard intubation: 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: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Comfort — 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

Trial sites (2)

FacilityCityRegionStatus
Rennes University Hospital Rennes Brittany Region Recruiting
Tours University Hospital Tours France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05790733 on ClinicalTrials.gov ↗ ← All trials in France