Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-06 @ 4:41 AM
Study NCT ID:
NCT06424093
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015907', 'term': 'Hysteroscopy'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2024-05-11', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Pain', 'timeFrame': '10 minutes from starting the procedure', 'description': 'The pain level of the cases is evaluated by means of the digital pain as the 11-point visual analog scale (VAS) whereas 0-Represents no pain, 10 - Worst imaginable pain), as well as the 11-point VAS-A (0-Represents no anxiety, 10 - Highest anxiety)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hysteroscopy', 'Acute Pain', 'Anxiety', 'Virtual Reality'], 'conditions': ['Acute Pain', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider.\n\nVirtual reality (VR), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. It is a computer-generated representation of an immersive videos viewed through a headset.', 'detailedDescription': 'Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider. Such procedures are usually well tolerated , However it can be associated with acute pain and anxiety. Options of Pain relief include sedation, local anaesthetic , analgesics and distraction techniques, however no consistent good quality evidence exists to support practice.\n\nVirtual reality (VR), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. It is a computer-generated representation of an immersive videos viewed through a headset. The obstacles of cost, quality and accessibility of (VR) devices have significantly eliminated in recent years and offer promising application in the medical field. Virtual reality for managing pain has been studied in many fields including paediatrics, dentistry, burns treatment, chronic pain, labour, and episiotomy.\n\nAlthough a meta-analysis suggested that VR may have a role in reducing pain scores in acutely painful interventions , studies found it to be effective only in needles and burns physical therapy.\n\nThe studies of VR on pain and anxiety, however, were limited by clinical and statistical heterogeneity.\n\nNonpharmacological options of pain relief have not explored enough the role of VR in reducing pain and improving patient experience in outpatient hysteroscopy .To our knowledge, there is only one publication studying the role of virtual reality in the management of acute pain during office gynaecological procedures'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients scheduled for diagnostic hysteroscopy e.g. Infertility, AUB\n\nExclusion Criteria:\n\n* Absolute contraindication to office hysteroscopy such as acute pelvic infection , active genital herpes , heavy bleeding or pregnancy.\n* Psychological ,hearing or visual disorders.\n* known anatomical condition that make performing office hysteroscopy is difficult such as cervical stenosis ,fibrosis or cervical amputation .\n* Previous history of failed office hysteroscopy\n* Patients scheduled for operative hysteroscopy.'}, 'identificationModule': {'nctId': 'NCT06424093', 'briefTitle': 'Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Egymedicalpedia'}, 'officialTitle': 'Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'Virtual Reality Technology'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Cases Group', 'description': 'About 25 women indicated for diagnostic hysteroscopy with using Virtual Reality Technology', 'interventionNames': ['Procedure: Virtual Reality Technology']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B: Control Group', 'description': 'About 25 women indicated for diagnostic hysteroscopy without using Virtual Reality Technology', 'interventionNames': ['Procedure: Virtual Reality Technology']}], 'interventions': [{'name': 'Virtual Reality Technology', 'type': 'PROCEDURE', 'otherNames': ['Hysteroscopy'], 'description': 'To evaluate the role of virtual reality technology as distraction technique in the management of acute pain during outpatient hysteroscopy', 'armGroupLabels': ['Group A: Cases Group', 'Group B: Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Eid Elsayed Zidan, MSc', 'role': 'CONTACT', 'email': 'dr.a.zidan87@gmail.com', 'phone': '+201067845518'}, {'name': 'Joseph Adel Ibrahim, MSc', 'role': 'CONTACT', 'email': 'joseph.johny2010@gmail.com', 'phone': '+201285515950'}, {'name': 'Rania Gamal Anwar, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yassin Asaad Mostafa, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Waleed Mohamed shawky, MSC', 'role': 'CONTACT', 'email': 'Waleed.shawky.94@gmail.com', 'phone': '+201093699004'}, {'name': 'Tarek Sabry Mohamed, MSC', 'role': 'CONTACT', 'email': 'Tareksabry44444@gmail.com', 'phone': '+201096398888'}], 'overallOfficials': [{'name': 'Amr Elhussieny, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of Obstetrics and Gynecology department , Faculty of Medicine, Ain Shams University'}, {'name': 'Mortada El Sayed Ahmed, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University'}, {'name': 'Radwa Rsaheedy Ali, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egymedicalpedia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}