Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-29 @ 5:08 PM
Study NCT ID:
NCT07074795
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-20
First Post:
2025-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Nitrous Oxide During Office Hysteroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D006175', 'term': 'Gynatresia'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized clinical trial of inhaled nitrous oxide vs inhaled ambient air'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subgroup differences in pain reduction associated with nitrous oxide during office hysteroscopy', 'timeFrame': 'Periprocedural (start to end of the hysteroscopy procedure)', 'description': 'To evaluate whether specific patient characteristics are associated with greater pain reduction from nitrous oxide use during office hysteroscopy.\n\nSubgroups include nulliparity, prior surgeries, prolonged procedure duration, type of procedure, and type of hysteroscopic device. Pain will be measured using visual analogue scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain. Assessments will be performed at three points: uterine entry, during the procedure and immediately after.'}, {'measure': 'Pre-procedural anxiety level assessed using modified State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'Immediately before the procedure', 'description': 'Anxiety levels will be assessed prior to the start of the hysteroscopy using a modified version of the State-Trait Anxiety Inventory (STAI) questionnaire. This tool evaluates both:\n\nState anxiety (temporary emotional state) Trait anxiety (long-term anxiety disposition) The state subscale includes 5 items, and the trait subscale includes 4 items.\n\nEach item is scored on a 5-point Likert scale (1 to 5), where:\n\n1 = lowest anxiety 5 = highest anxiety Total scores are calculated separately for state and trait components. Higher scores indicate greater anxiety.'}], 'primaryOutcomes': [{'measure': 'Comparison of Pain During Office Hysteroscopy Between Inhaled Nitrous Oxide (Treatment Group) and Ambient Air (Placebo Group)', 'timeFrame': 'Periprocedural (start to end of the hysteroscopy procedure)', 'description': 'The difference in pain between the two groups will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain.\n\nPain scores will be collected at three time points throughout the procedure\n\n: uterine entry, during the procedure, and immediately after its completion.'}], 'secondaryOutcomes': [{'measure': 'Incidence of side effects related to inhaled substance', 'timeFrame': 'Periprocedural (start to end of the hysteroscopy procedure)', 'description': 'The number and type of side effects reported during the procedure following administration of the inhaled agent (nitrous oxide or ambient air), including nausea, dizziness and presyncope. Adverse events will be recorded and categorized.'}, {'measure': 'Procedure completion', 'timeFrame': 'Periprocedural', 'description': 'Success is defined as the completion of the planned hysteroscopy procedure without the need for an additional intervention - either a repeat hysteroscopy or transfer to the operating room.\n\nThe outcome will be measured as the percentage of participants for whom the procedure was successfully completed as planned.'}, {'measure': 'Patient satisfaction with the procedure', 'timeFrame': 'Immediately post-procedure', 'description': 'Assessed after the procedure by a binary question: "Would you be willing to undergo the same procedure again with the same inhaled agent?" (Yes/No)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inhaled nitrous oxide', 'Office hysteroscopy', 'Pain management', 'Visual analogue scale (VAS)', 'Anxiety reduction', 'Gynecology'], 'conditions': ['Abnormal Uterine Bleeding', 'Postmenopausal Bleeding', 'Endometrial Polyps', 'Retained Products of Conception', 'Uterine Fibroids', 'Intrauterine Adhesions']}, 'referencesModule': {'references': [{'pmid': '24356165', 'type': 'BACKGROUND', 'citation': 'Likis FE, Andrews JC, Collins MR, Lewis RM, Seroogy JJ, Starr SA, Walden RR, McPheeters ML. Nitrous oxide for the management of labor pain: a systematic review. Anesth Analg. 2014 Jan;118(1):153-67. doi: 10.1213/ANE.0b013e3182a7f73c.'}, {'pmid': '30916011', 'type': 'BACKGROUND', 'citation': 'Buhre W, Disma N, Hendrickx J, DeHert S, Hollmann MW, Huhn R, Jakobsson J, Nagele P, Peyton P, Vutskits L. European Society of Anaesthesiology Task Force on Nitrous Oxide: a narrative review of its role in clinical practice. Br J Anaesth. 2019 May;122(5):587-604. doi: 10.1016/j.bja.2019.01.023. Epub 2019 Feb 22.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.contraception.2016.09.006', 'label': 'Similar study principle evaluating inhaled nitrous oxide vs oral analgesia during office hysteroscopy'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess the use of inhaled nitrous oxide during office hysteroscopy.\n\nThe main questions it aims to answer are:\n\n* Does it reduce pain during the procedure?\n* Does it increase the success rate?\n* Does it improve patient satisfaction?\n* Does it reduce anxiety?\n* Which populations benefit more (e.g., parity, menopausal status, number of previous surgeries, type and duration of procedure, and type of device)?\n\nParticipants will be asked about their pain levels during the procedure, as well as their anxiety levels. All responses will be recorded.\n\nWritten informed consent will be obtained prior to initiation.', 'detailedDescription': 'Office hysteroscopy offers a convenient alternative to operating room-based procedures, yet many patients experience pain and anxiety significant enough to interfere with procedural completion. Nitrous oxide is a fast-acting inhaled agent with both analgesic and anxiolytic properties, widely used in outpatient settings across various medical specialties.\n\nThis study will investigate the role of nitrous oxide in improving patient tolerability and comfort during office hysteroscopy. Participants will undergo a standardized procedural protocol with either nitrous oxide or ambient air administered via a demand-valve mask system. Comprehensive data on patient responses during the procedure will be collected and analyzed.\n\nThe study will also examine variability in patient responses across different subgroups and procedural types. All procedures will adhere to ethical standards, and patient confidentiality will be maintained throughout.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-identified females assigned female at birth are eligible to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen aged ≥18 years Scheduled to undergo operative office hysteroscopy for clinical indications\n\nExclusion Criteria:\n\nAny contraindications to N₂O, including:\n\nPneumothorax Significant chronic obstructive pulmonary disease (COPD) Upper airway obstruction Bowel obstruction Middle ear pathology (e.g., recent ear surgery or active ear infection) Severe recent intraocular gas injection Severe vitamin B12 deficiency Known hypersensitivity to N₂O\n\nWomen who will decline randomization or unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07074795', 'briefTitle': 'Use of Nitrous Oxide During Office Hysteroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Maaynei Hayesha Medical Center'}, 'officialTitle': 'Nitrous Oxide During Office Hysteroscopy for Reducing Pain and Anxiety', 'orgStudyIdInfo': {'id': '0002-24mhmc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'treatment- inhaled nitrous oxide', 'description': 'Participants in the Nitrous Oxide group will inhale a fixed 50:50 mixture of nitrous oxide (N₂O) and oxygen (O₂), starting one minute prior to the procedure and continuing throughout its duration.\n\nThe gas is administered via a self-administered demand-valve face mask connected to the Blendox system (Ambulanc®, Italy).', 'interventionNames': ['Procedure: Inhalation of Nitrous Oxide (N₂O) during Office Operative Hysteroscopy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inhaled ambient air control group', 'description': 'Participants in the control group will inhale ambient air starting one minute prior to the procedure and will continue inhalation throughout its duration.\n\nThe ambient air is administered via a self-administered demand-valve face mask connected to the Blendox system (Ambulanc®, Italy).', 'interventionNames': ['Procedure: inhalation of ambient air during office hysteroscopy']}], 'interventions': [{'name': 'Inhalation of Nitrous Oxide (N₂O) during Office Operative Hysteroscopy', 'type': 'PROCEDURE', 'description': 'Inhaled nitrous oxide', 'armGroupLabels': ['treatment- inhaled nitrous oxide']}, {'name': 'inhalation of ambient air during office hysteroscopy', 'type': 'PROCEDURE', 'description': 'inhalation of ambient air', 'armGroupLabels': ['Inhaled ambient air control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51544', 'city': 'Bnei Brak', 'country': 'Israel', 'facility': 'Mayanei HaYeshua Medical Center', 'geoPoint': {'lat': 32.08074, 'lon': 34.8338}}], 'overallOfficials': [{'name': 'Tamar Tzur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayanei Hayeshua Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'De-identified individual participant data (IPD) and supporting information will be made publicly available at the time of primary results publication in a peer-reviewed journal.\n\nThe data will remain accessible indefinitely via an open-access online repository.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD), including pain scores, anxiety scores, demographic characteristics, and procedural outcomes, will be made publicly available through an open-access data repository (e.g., Zenodo) at the time of primary results publication.\n\nThe data will be freely accessible for academic and research use, with no restrictions or approval required.', 'accessCriteria': 'The IPD and supporting documents will be accessible to all users via open access. No request or approval will be required.\n\nA direct link to the data repository (e.g., Figshare, Zenodo) will be provided in the publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maaynei Hayesha Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'P.I Dr Tamar Tzur. Senior gynecologist at Maaynei Hayesha', 'investigatorFullName': 'Dr. Tamar Zur', 'investigatorAffiliation': 'Maaynei Hayesha Medical Center'}}}}