Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 6:31 PM
Study NCT ID:
NCT04358094
Status:
UNKNOWN
Last Update Posted:
2020-04-22
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conversational Hypnosis for Peripherical Veinous Access (HYPNACESS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-01-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-21', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesia assessment by digital pain scale', 'timeFrame': 'immediately after applying the peripherical veinous catheter dressing', 'description': 'Digital pain scale: it describes the severity of the pain On this scale, "0" represents "no pain" and "10" represents "the worst possible pain"'}], 'secondaryOutcomes': [{'measure': 'Level of anxiety by numerical scale', 'timeFrame': 'before randomization and immediately after peripherical veinous catheter set up', 'description': 'Digital scale: it describes the severity of the pain On this scale, "0" represents "no anxiety" and "10" represents "the worst possible anxiety"'}, {'measure': 'patient satisfaction within the perioperative period (EVAN G questionnaire)', 'timeFrame': 'between 4 and 48 hours after the procedure', 'description': 'EVAN G questionnaire: Score from 0 to 100\n\nThe higher the score, the higher the level of patient satisfaction'}, {'measure': 'Heart rate', 'timeFrame': 'during the procedure', 'description': 'maximum heart rate'}, {'measure': 'Nurse anesthetist feeling about using the script after each use by digital scale', 'timeFrame': 'immediately after procedure', 'description': 'Evaluate how nurse anesthetist feels about using the script after each use by digital scale ranging from 0 to 10.\n\nOn this scale, "0" represents " uncomfortable" and "10" represents " very comfortable "'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vascular Access Site Pain']}, 'referencesModule': {'references': [{'pmid': '2208537', 'type': 'BACKGROUND', 'citation': 'Armstrong P, Young C, McKeown D. Ethyl chloride and venepuncture pain: a comparison with intradermal lidocaine. Can J Anaesth. 1990 Sep;37(6):656-8. doi: 10.1007/BF03006485.'}, {'pmid': '12685642', 'type': 'BACKGROUND', 'citation': 'Nir Y, Paz A, Sabo E, Potasman I. Fear of injections in young adults: prevalence and associations. Am J Trop Med Hyg. 2003 Mar;68(3):341-4.'}, {'pmid': '21856077', 'type': 'BACKGROUND', 'citation': 'Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.'}, {'pmid': '15915023', 'type': 'BACKGROUND', 'citation': 'Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, Francois G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23. doi: 10.1097/00000542-200506000-00010.'}]}, 'descriptionModule': {'briefSummary': "The peripherical veinous catheterization is required for anesthesia. However, it's a painful procedure and causes stress or even phobia.\n\nHypnosis can be seen as an interesting tool. Conversational hypnosis needs no training. It is used by script, which makes it easier.\n\nThe working hypothesis for study is that the conversational hypnosia script reduces pain during the set up of peripherical veinous access.\n\nThe main objective is the analgesia assessment of conversational hypnosis script for peripherical veinous catheter set up versus standard script in operating room. A nurse anesthetist is reading the conversational script or standard script during the procedure. The nurse anesthetist is untrained for hypnosis.\n\nThe secondary objective are the level of anxiety, patient satisfaction within the perioperative period (EVAN G questionnaire), the heart rate and the evaluation how nurse anesthetist feels about using the script after each use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Digestive endoscopy procedure under general anesthesia in one of the participating centers\n* Patient speaking and understanding French\n* Patient affiliated or entitled to a social security scheme\n* Patient who received enlightened information about the study and who co-signed, with the investigator, a consent to participate after a minimum period of reflection\n\nExclusion Criteria:\n\n* Patient with deafness\n* Patient with cognitive impairment\n* Pregnant and / or breastfeeding patient\n* Patient with dissociative disorders (contraindication to hypnosis)\n* Patient suffering from a pathology which can cause chronic pain\n* Patient receiving analgesia or anxiety drug\n* Patient under justice, curatorship or tutorship\n* Patient deprived of liberty by judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT04358094', 'acronym': 'HYPNACESS', 'briefTitle': 'Conversational Hypnosis for Peripherical Veinous Access (HYPNACESS)', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Analgesia Assessment of Conversational Hypnosis Script During Peripherical Veinous Catheter Set up Versus Standard Script in Operating Room', 'orgStudyIdInfo': {'id': '2020-A00187-32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conversational hypnosis script', 'description': 'Patient who received conversational hypnosis script during peripherical veinous access set up', 'interventionNames': ['Other: Conversational hypnosis script']}, {'type': 'OTHER', 'label': 'Standard script', 'description': 'Patient who received standard script during peripherical veinous access set up', 'interventionNames': ['Other: Standard script']}], 'interventions': [{'name': 'Conversational hypnosis script', 'type': 'OTHER', 'description': 'Conversational hypnosis during peripherical veinous catheter set up', 'armGroupLabels': ['Conversational hypnosis script']}, {'name': 'Standard script', 'type': 'OTHER', 'description': 'Standard script during peripherical veinous catheter set up', 'armGroupLabels': ['Standard script']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'contacts': [{'name': 'Hervé Bouaziz, Pr', 'role': 'CONTACT', 'email': 'h.bouaziz@chru-nancy.fr', 'phone': '0383851403'}], 'facility': 'Centre Hospitalier Régional Universitaire', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Hervé Bouaziz, Pr', 'role': 'CONTACT', 'email': 'h.bouaziz@chru-nancy.fr', 'phone': '0383851403'}], 'overallOfficials': [{'name': 'Hervé Bouaziz, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}