Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT05790733
Status:
RECRUITING
Last Update Posted:
2024-10-09
First Post:
2023-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HYPNONAG : Therapeutic Communication Versus Traditional Method for Naso-gastric Intubation in Haematology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, bicentric, interventional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort', 'timeFrame': 'Within 3 minutes after the end of the intubation', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Pain visual analogue scale', 'timeFrame': 'Immediately after the assessment of the comfort scale (assessed within 3 minutes after the end of the intubation)', 'description': '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.'}, {'measure': 'Anxiety', 'timeFrame': '5 minutes (+/- 1 minute) before the NGS placement starts and repeated immediately after the procedure ends (just after the pain assessment)', 'description': '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).'}, {'measure': 'Success or failure of the NGS placement according to the randomization arm', 'timeFrame': 'During procedure', 'description': 'Success or failure of the NGS placement after using the method (standard method versus hypnosis) given by the randomization arm'}, {'measure': 'Number of failures', 'timeFrame': 'During procedure', 'description': '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).'}, {'measure': 'Weight', 'timeFrame': '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', 'description': 'Weight at entry and exit from hospitalization in the hematology department.'}, {'measure': 'Muscular strength', 'timeFrame': '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', 'description': 'Muscular strength assessed by means of a dynamometer at entry and exit from hospitalization in the hematology department'}, {'measure': 'Total number of days of presence of the NGS', 'timeFrame': 'During the hospitalization time (up to 3 months)', 'description': 'The total number of days of presence of the NGS during the hospitalization time'}, {'measure': 'Attempt or not of a new NGS intubation (in case of rejection of the first probe by vomiting)', 'timeFrame': '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', 'description': 'In case of rejection of the first probe by vomiting during hospitalization, attempt or not of a new NGS intubation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasogastric intubation'], 'conditions': ['Aplasia', 'Chemotherapy Effect']}, 'descriptionModule': {'briefSummary': "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.\n\nNGS 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.\n\nThe installation of the NGS is often recognized as a traumatic gesture for patients but also invasive by caregivers.\n\nThe 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.", 'detailedDescription': '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").\n\nAs 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.\n\nWhen the patient will be randomized in the hypnosis arm, he will place his NGS himself with a hypnotic accompaniment, described in appendix.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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;\n* Age ≥ 18 years;\n* Affiliated to a social security scheme;\n* Having signed a free, informed and written consent.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women;\n* Patient who refuses NGS;\n* Emergency surgery;\n* Patients consuming long-term opiates before surgery;\n* Substance addiction;\n* Patient at the end of life and/or in palliative care;\n* Patient unable to answer a questionnaire and/or unable to understand the rating scales;\n* Deaf and/or dumb patients;\n* Patients with psychiatric pathologies (schizophrenia, bipolarity);\n* Persons subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.'}, 'identificationModule': {'nctId': 'NCT05790733', 'acronym': 'HYPNONAG', 'briefTitle': 'HYPNONAG : Therapeutic Communication Versus Traditional Method for Naso-gastric Intubation in Haematology', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'HYPNONAG : Therapeutic Communication Versus Traditional Method for Naso-gastric Intubation in Haematology: Randomized Controlled Clinical Study', 'orgStudyIdInfo': {'id': '35RC22_9836_HYPNONAG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'description': '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").\n\nThis arm involves the use of the 5% Xylocaine nebulizer spray and a single-use cannula.\n\nThe 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.', 'interventionNames': ['Other: Standard intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Hypnosis', 'description': '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.\n\nAs 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.\n\nThe installation of the SNG with hypnosis will be carried out according to the protocol set out in appendix 4.\n\nIn the hypnosis arm, there will be none local anesthesia.', 'interventionNames': ['Other: Hypnosis']}], 'interventions': [{'name': 'Standard intubation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Standard']}, {'name': 'Hypnosis', 'type': 'OTHER', 'description': '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.\n\nAs 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.\n\nThe installation of the NGS with hypnosis will be carried out according to the protocol set out in appendix 4.', 'armGroupLabels': ['Hypnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'state': 'Brittany Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Magali GRANGER, Nurse', 'role': 'CONTACT', 'email': 'magali.granger@chu-rennes.fr', 'phone': '0299284321', 'phoneExt': '87 290'}, {'name': 'Thierry LAMY, MD', 'role': 'CONTACT', 'email': 'thierry.lamy.de.la.chapelle@chu-rennes.fr'}, {'name': 'Magali GRANGER, Nurse', 'role': 'CONTACT'}, {'name': 'Thierry LAMY, MD', 'role': 'CONTACT'}], 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37000', 'city': 'Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel Gyan, MD', 'role': 'CONTACT', 'email': 'e.gyan@chu-tours.fr'}, {'name': 'Olivia Werle, Nurse', 'role': 'CONTACT', 'email': 'o.werle@chu-tours.fr'}, {'name': 'Emmanuel Gyan, MD', 'role': 'CONTACT'}, {'name': 'Olivia Werle, Nurse', 'role': 'CONTACT'}], 'facility': 'Tours University Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Magali GRANGER, nurse', 'role': 'CONTACT', 'email': 'magali.granger@chu-rennes.fr', 'phone': '02 99 28 43 21', 'phoneExt': '87290'}, {'name': 'Thierry LAMY, MD', 'role': 'CONTACT', 'email': 'thierry.lamy.de.la.chapelle@chu-rennes.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}