Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-04-11 @ 2:58 AM
Study NCT ID:
NCT06502457
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Management With Virtual Reality Hypnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 142}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity difference between the first analgesic procedure and 30min later', 'timeFrame': '30 minutes', 'description': 'Assessment of PID (pain intensity difference) between the first analgesic procedure and 30min later.'}], 'secondaryOutcomes': [{'measure': 'Average consumption of analgesics', 'timeFrame': '12 hours', 'description': 'Average consumption of analgesics (morphine agonists and other analgesics) during the latency or maturation period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypnosis', 'labor pain', 'virtual reality', 'labor induction', 'latent period'], 'conditions': ['Hypnosis', 'Labor Pain', 'Virtual Reality', 'Labor Induction', 'Latent Period']}, 'descriptionModule': {'briefSummary': 'The latency phase corresponds to the first phase of the first stage of labour, during which the parturient feels regular, rhythmic uterine contractions that are often painful, with or without changes of the cervix. This phase lasts an average of 8 hours for primiparous women, compared with 5 hours for multiparous women, and can last up to twenty hours in total.\n\nCervical ripening corresponds to the medical induction of regular, painful uterine contractions in order to obtain a favourable cervix for the induction of labour. Cervical ripening is carried out either medically (oral or local prostaglandins) or mechanically (double balloon dilatation) and accounts for 69.2% of labour inductions, which in turn account for 25.8% of births.\n\nAt Amiens-Picardie University Hospital, this maturation stage can last from a few hours to 2 days, depending on the service protocol.\n\nWhat these two stages of childbirth have in common is that they are both painful, with very few analgesic drugs available that can be used without side-effects on the foetus during pregnancy.\n\nIn recent years, there has also been a growing demand from parturients for the use of non-medicinal therapies.\n\nIt therefore seems essential to provide parturients with as many effective non-drug methods as possible to manage their pain properly.\n\nIf virtual reality hypnosis sessions prove to be effective, they will provide better pain management for women in labour, reduce the use of morphine derivatives (with their attendant side-effects, particularly on the foetus), and above all meet the growing demand from women in labour for the most physiological possible support during childbirth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parturient over 18\n* Parturient who speaks and understands French\n* Parturient hospitalised prior to labour\n* Membranes intact or ruptured\n* Spontaneous or induced labour\n* Parturient in latency phase\n* Term ≥ 37SA\n* END \\> 3\n* Parturient requiring active pain management (medicinal or non-medicinal)\n* Low-risk pregnancy\n\nExclusion Criteria:\n\n* Parturient under legal protection\n* Parturient with a hearing impairment\n* Parturient with visual impairment\n* Parturient with epilepsy\n* Parturient with psychiatric problems\n* Pathological pregnancy\n* Parturient with chronic pain\n* Parturient with addiction-related disorders\n* Parturient allergic to paracetamol\n* Parturient allergic to phloroglucinol\n* Parturient allergic to codeine\n* Parturient allergic to nalbuphine\n* Parturient allergic to orozamudol'}, 'identificationModule': {'nctId': 'NCT06502457', 'acronym': 'PreVR', 'briefTitle': 'Pain Management With Virtual Reality Hypnosis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Pain Management With Virtual Reality Hypnosis in Parturients in the Latency or Cervical Ripening Phase', 'orgStudyIdInfo': {'id': 'PI2024_843_0067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'interventionNames': ['Drug: painkiller']}, {'type': 'EXPERIMENTAL', 'label': 'hypnosis group', 'interventionNames': ['Other: hypnosis group']}], 'interventions': [{'name': 'painkiller', 'type': 'DRUG', 'description': 'The control group will receive a painkiller adapted to the service protocol after the fetal heart rate has been recorded.', 'armGroupLabels': ['control group']}, {'name': 'hypnosis group', 'type': 'OTHER', 'description': 'The hypnosis group will receive a hypnosis session after the fetal heart rate has been recorded. Automated measurement of blood pressure and maternal heart rate will take place during the session in order to objectively assess the impact of the session on the mother.\n\nPatients in the hypnosis group will then have access to the virtual reality headset on request throughout the latency or maturation phase, and will also be able to benefit from a painkiller in accordance with the service protocol if they so request.', 'armGroupLabels': ['hypnosis group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien VARGAS, MD', 'role': 'CONTACT', 'email': 'Vargas.julien@chu-amiens.fr', 'phone': '0322088281'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}