Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-27 @ 12:30 PM
Study NCT ID:
NCT03755895
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2018-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C534042', 'term': 'kalinox'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2018-11-26', 'studyFirstSubmitQcDate': '2018-11-27', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety evaluation', 'timeFrame': '1day', 'description': 'The patient\'s anxiety will be assessed using the State-Trait Anxiety Inventory scale ("state of anxiety") before premedication (in the bedroom) and immediately after the brachytherapy detachment (in the examination room) during brachytherapy detachment using two care management: standard care versus standard care with formal hypnosis. The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger et al, 1983). The scale include 20 items. Higher scores indicate greater anxiety'}], 'secondaryOutcomes': [{'measure': 'Pain evaluation: numeric scale', 'timeFrame': '1 day', 'description': 'Pain will be evaluated by a numeric scale before premedication (in the room), just before and just after the brachytherapy detachment (in the examination room). Patient inform their level of pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain'}, {'measure': 'Anxiety evaluation', 'timeFrame': '1 day', 'description': 'Anxiety will be evaluated by a numeric scale just before and just after the brachytherapy detachment. Patient inform their level of anxiety from 0 to 10 (11 point scale) with the understanding that 0 is equal to no anxiety and 10 is equal to worst possible anxiety'}, {'measure': "Patient's perception of the care", 'timeFrame': '1day', 'description': "The patient's perception of the care will be evaluated by a semi-directive phone interview conducted by the medical staff between day 3 and day 5 after the brachytherapy detachment"}, {'measure': 'Time of brachytherapy detachment', 'timeFrame': '1day', 'description': "The time of brachytherapy detachment will be noted from the entrance to the patient's examination room until the end of the brachytherapy detachment"}, {'measure': 'Realization of the brachytherapy detachment', 'timeFrame': '1day', 'description': 'The ease of realization of the brachytherapy detachment and the comfort of the medical staff will be evaluated by an numeric scale at the end of the care and by a self-survey'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'hypnosis', 'care management'], 'conditions': ['Cancer', 'Brachytherapy']}, 'referencesModule': {'references': [{'pmid': '40883194', 'type': 'BACKGROUND', 'citation': 'Lemoine L, Adam V, Salleron J, Cuisinier C, Perrin J, Brunaud CC, Jean-Francois P, Bruand M, Peiffert D, Etienne R, Schohn CH, Renard S. Randomized trial comparing hypnosis versus standard management on patient anxiety and pain during pelvic brachytherapy applicator removal. Brachytherapy. 2025 Nov-Dec;24(6):854-862. doi: 10.1016/j.brachy.2025.07.010. Epub 2025 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'Formal hypnosis is a non-drug technique known to decrease anxiety and pain during the preoperative procedure.\n\nIn brachytherapy, the practice of hypnosis has been shown to be feasible and beneficial for patients treated for prostate cancer The goal of the study is to demonstrate the added value of hypnosis during a brachytherapy detachment by improving the comfort of the patient.\n\nThe investigators want to evaluate the contribution of hypnosis during brachytherapy detachment by quantifying the anxiety and pain felt by the patient during the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ≥ 18 and ≤ 80 years\n* Patients expected to benefit a brachytherapy detachment Under KALINOX® for one of the types of applications described below:\n\n * Deep interstitial application: anal canal, vagina, vulva\n * Gynecological application: mold, Utrecht® system or Venezia® system\n* Ability to provide written informed consent\n* Patients affiliated to the social security system\n\nExclusion Criteria:\n\n* Minor and patients over 80 years old\n* Patients with major hearing loss\n* Patients who had recent ocular surgery with oculiare gas injection.\n* Patients suffering from psychotic disorders, and dementias.\n* Patients who do not understand the French language\n* Patients under guardianship or deprived of liberty\n* Patients with a contraindication to the administration of KALINOX®'}, 'identificationModule': {'nctId': 'NCT03755895', 'acronym': 'HYCUDES', 'briefTitle': 'Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de Lorraine'}, 'officialTitle': 'Randomized Trial Comparing the Hypnosis Versus Standard Care of Anxiety and Pain in Patients With Brachytherapy', 'orgStudyIdInfo': {'id': '2018-004527-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis', 'interventionNames': ['Other: formal hypnosis', 'Drug: Kalinox']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'active comparator', 'description': 'patients to benefit from brachytherapy detachment under KALINOX', 'interventionNames': ['Drug: Kalinox']}], 'interventions': [{'name': 'formal hypnosis', 'type': 'OTHER', 'description': 'patients will have brachytherapy detachment under Kalinox and formal hypnosis', 'armGroupLabels': ['experimental']}, {'name': 'Kalinox', 'type': 'DRUG', 'description': 'patients will have brachytherapy detachment under Kalinox', 'armGroupLabels': ['active comparator', 'experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54519', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Institut de Cancérologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Sophie RENARD, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cancérologie de Lorraine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de Lorraine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}