Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-20 @ 2:30 PM
Study NCT ID:
NCT06625567
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Preoperative Animated Videos on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A prospective, non-blinded, randomized comparative study including patients undergoing hysteroscopy without anesthesia in the outpatient hysteroscopy clinic at Shamir (Assaf Harofe) medical center. In the control group, patients will receive the standard education regarding the procedure. In the study group, patients will also watch a short educational video.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2024-09-27', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety levels before the procedure', 'timeFrame': 'Immediately before procedure', 'description': 'Anxiety levels before the procedure will be assesses according to the State-Trait Anxiety Inventory - State questionnaire which is composed out of 20 questions. Scoring is 1-4 for each question and total score is calculated using a formula with a final score of under 30 indicating low anxiety, 31-45 moderate anxiety and 46 and above high level of anxeity . The hysteroscopy will be performed according to the routine clinical care.'}], 'secondaryOutcomes': [{'measure': 'Pain levels after procedure', 'timeFrame': 'Immediately after procedure', 'description': 'Pain levels measure by Visual Analogue Scale scored from 0-10 (0 indicating no pain and 10 the highest level of pain) after procedure is done'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '23962572', 'type': 'RESULT', 'citation': 'Angioli R, De Cicco Nardone C, Plotti F, Cafa EV, Dugo N, Damiani P, Ricciardi R, Linciano F, Terranova C. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):454-9. doi: 10.1016/j.jmig.2013.07.020. Epub 2013 Aug 17.'}, {'pmid': '22387163', 'type': 'RESULT', 'citation': 'Carta G, Palermo P, Marinangeli F, Piroli A, Necozione S, De Lellis V, Patacchiola F. Waiting time and pain during office hysteroscopy. J Minim Invasive Gynecol. 2012 May-Jun;19(3):360-4. doi: 10.1016/j.jmig.2012.01.017. Epub 2012 Mar 3.'}, {'pmid': '32140807', 'type': 'RESULT', 'citation': 'Vitale SG, Caruso S, Ciebiera M, Torok P, Tesarik J, Vilos GA, Cholkeri-Singh A, Gulino FA, Kamath MS, Cianci A. Management of anxiety and pain perception in women undergoing office hysteroscopy: a systematic review. Arch Gynecol Obstet. 2020 Apr;301(4):885-894. doi: 10.1007/s00404-020-05460-2. Epub 2020 Mar 5.'}, {'pmid': '26283891', 'type': 'RESULT', 'citation': 'Gambadauro P, Navaratnarajah R, Carli V. Anxiety at outpatient hysteroscopy. Gynecol Surg. 2015;12(3):189-196. doi: 10.1007/s10397-015-0895-3. Epub 2015 May 13.'}]}, 'descriptionModule': {'briefSummary': "Office hysteroscopy is a gynecologic procedure performed to evaluate the uterine cavity. In the majority of cases, this procedure is performed without anesthesia.\n\nPrevious studies found significant levels of anxiety in women undergoing this procedure. In the current study, we will assess if the use of a preoperative audiovisual animated video describing will affect patient's anxiety and pain.\n\nAll patients will receive the standard education regarding the procedure from the physician. In the study group, in addition, an educational animated video will be shown. Subsequently, all patients will be asked to fill an anxiety assessment questionnaire in Hebrew (State-Trait Anxiety Inventory - State). After the procedure, patients will be asked about their pain level (VAS). Finally, patients in the study group will be asked to fill a short questionnaire regarding the educational video.", 'detailedDescription': 'Backgroung: Office hysteroscopy is a gynecologic procedure performed to evaluate the uterine cavity in cases of various gynecologic problems and abnormal ultrasound findings (such as endometrial polyps, fibroids, abnormal uterine bleeding, and infertility). In the majority of cases, this procedure is performed without anesthesia using a small diameter (\\~3-4 mm) fibro-optic equipment and a minimally invasive "no-touch" vaginoscopic technique. Although this procedure is considered to be non-painful and well tolerated, previous studies found significant levels of anxiety in women undergoing hysteroscopy without anesthesia. Several non-pharmacologic approaches have been suggested with the aim of decreasing patients\' anxiety. Among those, communication and patient\'s education appear to have a significant role. In the current study, we will assess the effect of an educational video describing the procedure on patients\' anxiety before hysteroscopy without anesthesia, and compare it to the anxiety levels of patients who received the standard education.\n\nObjective To assess if the use of a preoperative audiovisual animated video describing hysteroscopy without anesthesia will affect patient\'s anxiety and pain.\n\nDesign A prospective, non-blinded, randomized comparative study including patients undergoing hysteroscopy without anesthesia in the outpatient hysteroscopy clinic at Shamir (Assaf Harofe) medical center. In the control group, patients will receive the standard education regarding the procedure. In the study group, patients will also watch a short educational video.\n\nInclusion criteria:\n\nAdult patients (≥18 years) undergoing hysteroscopy without anesthesia in the hysteroscopy outpatient clinic.\n\nExclusion criteria:\n\n1. Patients who are unable to understand or watch the audiovisual video\n2. Patients who are unable to understand or to complete the Hebrew questionnaires. The study will include a total of 200 patients. The patients will be randomly assigned to the study or to the control group according to the day of the procedure (i.e., on select pre-determined days all patients will be assigned either to the control group or to the study group).\n\nAll patients will receive the standard education regarding the procedure from the physician. In the study group, in addition, an educational animated video will be shown. Subsequently, all patients will be asked to fill an anxiety assessment questionnaire in Hebrew (State-Trait Anxiety Inventory - State) (Appendix 1). The hysteroscopy will be performed according to the routine clinical care. After the procedure, patients will be asked about their pain level (VAS). Finally, patients in the study group will be asked to fill a short questionnaire regarding the educational video (Appendix 2).\n\nDemographic variable (age, body mass index, obstetrical history and gynecologic history) will be also collected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥18 years) undergoing hysteroscopy without anesthesia in the hysteroscopy outpatient clinic.\n\nExclusion Criteria:\n\n* Patients who are unable to understand or watch the audiovisual video\n* Patients who are unable to understand or to complete the Hebrew questionnaires.\n* Age \\< 18'}, 'identificationModule': {'nctId': 'NCT06625567', 'briefTitle': 'The Effect of Preoperative Animated Videos on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Effect of Preoperative Patient Education Via Animated Videos on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia', 'orgStudyIdInfo': {'id': '11-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients undergoing hysteroscopy without anesthesia. Patients will receive the standard education regarding the procedure.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Patients undergoing hysteroscopy without anesthesia. Patients will receive the standard education regarding the procedure and will also watch a short educational video.', 'interventionNames': ['Other: Animated video']}], 'interventions': [{'name': 'Animated video', 'type': 'OTHER', 'description': 'Patients will watch an educational video describing the procedure before hysteroscopy without anesthesia', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rishon LeZiyyon', 'country': 'Israel', 'facility': 'Shamir medical center', 'geoPoint': {'lat': 31.97102, 'lon': 34.78939}}], 'overallOfficials': [{'name': 'Neta Eisenberg Kogan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shamir Assaf Harofeh medical center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'The data will be shared onced sent to publication for unlimited time', 'ipdSharing': 'YES', 'description': 'The data that is collected will be shared', 'accessCriteria': 'The data will be published in suitable journals for that purpose'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician in the gynecology endoscopy unit', 'investigatorFullName': 'Neta Eisenberg Kogan', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}