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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy Effect; Aplasia
• Intervention / Treatment: Other: Standard intubation; Other: Hypnosis

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magali GRANGER, nurse; Phone Number: 87290 02 99 28 43 21; Email: magali.granger@chu-rennes.fr
• Study Contact Backup: Name: Thierry LAMY, MD; Email: thierry.lamy.de.la.chapelle@chu-rennes.fr

Study Locations

• France
  • Tours, France, 37000
    • Not yet recruiting
    • Tours University Hospital
    • Contact: Emmanuel Gyan, MD; Email: e.gyan@chu-tours.fr
    • Contact: Emmanuel Gyan, MD
    • Contact: Olivia Werle, Nurse; Email: o.werle@chu-tours.fr
    • Contact: Olivia Werle, Nurse
  • Bretagne
    • Rennes, Bretagne, France, 35033
      • Recruiting
      • Rennes University Hospital
      • Contact: Thierry LAMY, MD
      • Contact: Thierry LAMY, MD; Email: thierry.lamy.de.la.chapelle@chu-rennes.fr
      • Contact: Magali GRANGER, Nurse; Phone Number: 87 290 0299284321; Email: magali.granger@chu-rennes.fr
      • Contact: Magali GRANGER, Nurse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; 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; 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.
Experimental: 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 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 3 minutes after the end of the intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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	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).	During procedure
Weight	Weight at entry and exit from hospitalization in the hematology department.	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	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	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	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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Nasogastric intubation
• Other Study ID Numbers: 35RC22_9836_HYPNONAG; 2023-A00062-43 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No