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

NCT05790733 | Recruiting

• 1 other identifier: 35RC22_9836_HYPNONAG
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Aplasia; Chemotherapy Effect

Keywords

Nasogastric intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pain visual analogue scale

  Immediately after the assessment of the comfort scale (assessed within 3 minutes after the end of the intubation)

• Anxiety

  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

  During procedure

• Number of failures

  During procedure

• Weight

  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

Study Arms (2)

Standard

ACTIVE COMPARATOR

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

EXPERIMENTAL

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

Interventions

Standard intubation 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.

Standard

Hypnosis 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.

Hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (2)

Rennes University Hospital

Rennes, Brittany Region, 35033, France

RECRUITING

Tours University Hospital

Tours, 37000, France

NOT YET RECRUITING

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Magali GRANGER, nurse

CONTACT

02 99 28 43 21; magali.granger@chu-rennes.fr

Thierry LAMY, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, bicentric, interventional study

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 30, 2023
• Study Start: July 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)