Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-27 @ 4:32 PM
Study NCT ID:
NCT06497712
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2024-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BEnefit of HYpnosis on Pain During Stitches in Emergency Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of hypnosis during stitches among emergency department patients', 'timeFrame': 'Hour 0', 'description': 'Impact of hypnosis will be evaluated by the variability of heart frequency measured by heart rate monitoring belt'}], 'secondaryOutcomes': [{'measure': 'Impact of hypnosis on stress patients during stitches', 'timeFrame': 'Hour 0; Hour 0+30 minutes', 'description': 'Visual analog scale (VAS) of pain and stress will be performed at two different times by the patient.\n\nA VAS is a 100-mm long horizontal line with verbal descriptors at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their pain and severity between 0 (no symptoms) to 100 (the worst pain and stress).\n\nCut points on the pain VAS : no pain or low pain (0-29 mm), moderate pain (30-59 mm), and severe pain (\\>59 mm).\n\nCut points on the stress VAS : no pain or low stress (0-19 mm), moderate stress (19-49 mm), severe stress (50-81 mm), and at-risk stress (\\>81 mm).'}, {'measure': 'Evaluation of stress biomarkers in blood samples', 'timeFrame': 'Hour 0; Hour 0+30 minutes', 'description': 'Evaluation of cortisol, DHEA, DHEA-s, ghrelin, leptin, IL-8, TNF-alpha, epinephrin, noradrenalin, dopamine'}, {'measure': 'Evaluation of blood pressure', 'timeFrame': 'Hour 0; Hour 0+30 minutes', 'description': 'Evaluation of hypnosis impact on systolic and diastolic blood pressure in millimeter of mercury (mmHg)'}, {'measure': 'Evaluation of heart rate', 'timeFrame': 'Hour 0; Hour 0+30 minutes', 'description': 'Evaluation of hypnosis impact on physiological parameters heart rate in beats per minute (bpm)'}, {'measure': 'Impact of sociodemographics parameters on pain and stress', 'timeFrame': 'Hour 0; Hour 0+30 minutes', 'description': 'Evaluation of the impact of sociodemographics parameters on pain and stress evaluated by the visual analog scale (VAS) performed at two different times (outcome N°2)'}, {'measure': 'Impact of location of the wound on pain and stress', 'timeFrame': 'Hour 0; Hour 0+30 minutes', 'description': 'Evaluation of the impact of location of the wound on stress and pain evaluated by the visual analog scale (outcome n°2)'}, {'measure': 'Impact of location of the wound on variability of heart frequency', 'timeFrame': 'Hour 0; Hour 0+30 minutes', 'description': 'Evaluation of the impact of location of the wound on the variability of heart frequency measured by heart rate monitoring belt (outcome n°1)'}, {'measure': 'Impact of the length of the wound on pain and stress', 'timeFrame': 'Hour 0; Hour 0+30 minutes', 'description': 'Evaluation of the impact of the length of the wound on stress and pain evaluated by the visual analog scale (outcome n°2)'}, {'measure': 'Impact of the length of the wound on variability of heart frequency', 'timeFrame': 'Hour 0; Hour 0+30 minutes', 'description': 'Evaluation of the impact of the length of the wound on the variability of heart frequency measured by heart rate monitoring belt (outcome n°1)'}, {'measure': 'Impact of the depth of the wound on pain and stress', 'timeFrame': 'Hour 0; Hour 0+30 minutes', 'description': 'Evaluation of the impact of the depth of the wound on stress and pain evaluated by the visual analog scale (outcome n°2)'}, {'measure': 'Impact of the depth of the wound on pain and stress', 'timeFrame': 'Hour 0; Hour 0+30 minutes', 'description': 'Evaluation of the impact of the depth of the wound on the variability of heart frequency measured by heart rate monitoring belt (outcome n°1)'}, {'measure': 'sinusal variability of cardiac frequency on healthcare professional during stitching', 'timeFrame': 'Hour 0 and for 48 hours', 'description': 'measurement of sinus variability of heart rate in healthcare professionals performing wound care by a heart rate transmitter holter positionned on the chest'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypnosis', 'wound', 'stitches', 'pain', 'sinusal variability of cardiac frequency'], 'conditions': ['Wound of Skin']}, 'descriptionModule': {'briefSummary': 'Suturing is a daily practice in the emergency department, but it can be painful and stressful for patients. Hypnosis is increasingly used as a complement to the usual painkillers. The aim of our study was to investigate the impact of hypnosis on stitch placement in emergency department patients presenting with lacerations assessed by heart rate variability.', 'detailedDescription': 'The aim of this randomized, controlled, single-center, prospective study is to evaluate the impact of hypnosis during suturing in emergency department patients presenting with a laceration assessed by heart rate variability.\n\nAll patients with eligibility criteria will be included if the patient gave his written consent.\n\nPatients will be randomized to one of two arms: (1) Hypnosis or (2) Standard Of Care (SOC) A heart rate monitoring belt will be fitted to the patient for both groups. The patient will be asked to complete a self-assessment questionnaire on pain and stress, as well as socio-demographic parameters.\n\nA blood sample will be collected and the heart rate and blood pressure will be measured.\n\nStitches will be taken with or without hypnosis, and after 30 minutes, the pain and stress self-assessment questionnaire will again be completed by the patient, and a new blood test will be taken.\n\nthe heart rate monitoring belt will be removed, and the study will be completed for the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient over 18 years, admitted in Clermont-Ferrand University Hospital Emergency Department\n* suturable wound\n* patient's consent obtained\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Patient under guardianship, curators or safeguard of justice\n* Person unable to give consent\n* History of cardiac rhythm disorders (fibrillation, pacemaker)\n* Psychiatric pathology\n* Age \\< 18 years\n* Surgical wound\n* Eyelid, nose, ear or mouth wounds\n* Patients who do not speak French\n* Deaf patients\n* Patients with no social security coverage\n* Use of MEOPA\n* Intake of toxic substances\n* Head trauma with a Glasgow Score \\< or = to 14\n* Patient with endocrinal pathologies on cortisol axe\n* Refusal to take part in the study"}, 'identificationModule': {'nctId': 'NCT06497712', 'acronym': 'BE-HYPER', 'briefTitle': 'BEnefit of HYpnosis on Pain During Stitches in Emergency Room', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'BEnefit of HYpnosis on Pain During Stitches in Emergency Room: the BE-HYPER Study', 'orgStudyIdInfo': {'id': 'RBHP 2023 BOUILLON-MINOIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypnosis', 'description': 'Patients will be hypnotized by a trained person before suturing.', 'interventionNames': ['Other: Hypnosis']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Stitches will be performed without hypnosis as usual'}], 'interventions': [{'name': 'Hypnosis', 'type': 'OTHER', 'description': 'Before the beginning of stitches, the patient will be offered a hypnotic induction. The hypnotic induction is the initial phase of the hypnosis process. Its goal is to bring the patient to a state of dissociation: the hypnotic trance. Induction is usually achieved through progressive relaxation, sensory focusing, and a process of confusion.', 'armGroupLabels': ['Hypnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Baptiste Bouillon, MD, PhD', 'role': 'CONTACT', 'email': 'jbbouillon-minois@chu-clermontferrand.fr', 'phone': '+33473751999'}, {'name': 'Léa Pérard', 'role': 'CONTACT', 'email': 'lperard@chu-clermontferrand.fr'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'LISE LACLAUTRE', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '+33473754963'}], 'overallOfficials': [{'name': 'Jean-Baptiste BOUILLON-MINOIS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}