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

NCT ID: NCT05790733

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-08-01

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.

Conditions

Aplasia; Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard intubation

Intervention Type: OTHER

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 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.

Group Type: EXPERIMENTAL

Hypnosis

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rennes University Hospital

Rennes, Brittany Region, France

Site Status: RECRUITING

Tours University Hospital

Tours, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Magali GRANGER, nurse

Role: CONTACT

magali.granger@chu-rennes.fr

02 99 28 43 21 ext. 87290

Thierry LAMY, MD

Role: CONTACT

thierry.lamy.de.la.chapelle@chu-rennes.fr

Facility Contacts

Magali GRANGER, Nurse

Role: primary

magali.granger@chu-rennes.fr

0299284321 ext. 87 290

Thierry LAMY, MD

Role: backup

thierry.lamy.de.la.chapelle@chu-rennes.fr

Magali GRANGER, Nurse

Role: backup

Thierry LAMY, MD

Role: backup

Emmanuel Gyan, MD

Role: primary

e.gyan@chu-tours.fr

Olivia Werle, Nurse

Role: backup

o.werle@chu-tours.fr

Emmanuel Gyan, MD

Role: backup

Olivia Werle, Nurse

Role: backup

Other Identifiers

35RC22_9836_HYPNONAG

Identifier Type: -

Identifier Source: org_study_id