NCT05790733 HYPNONAG : Therapeutic Communication Versus Traditional Method for Naso-gastric Intubation in Haematology
| NCT ID | NCT05790733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rennes University Hospital |
| Condition | Aplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2024-07-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05790733 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05790733 currently recruiting?
Yes, NCT05790733 is actively recruiting participants. Contact the research team at magali.granger@chu-rennes.fr for enrollment information.
Where is the NCT05790733 trial being conducted?
This trial is being conducted at Rennes, France, Tours, France.
Who is sponsoring the NCT05790733 clinical trial?
NCT05790733 is sponsored by Rennes University Hospital. The trial plans to enroll 180 participants.