Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:07 AM
Study NCT ID:
NCT07364968
Status:
COMPLETED
Last Update Posted:
2026-01-23
First Post:
2025-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Preoperative Instructional Video on Patient Preparedness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-09', 'size': 571974, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-23T15:07', 'hasProtocol': True}, {'date': '2023-08-09', 'size': 1391767, 'label': 'Informed Consent Form: UCR Template Consent', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-01-18T14:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-18', 'studyFirstSubmitDate': '2025-10-24', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient level of satisfaction with the education they received prior to surgery', 'timeFrame': '6 months to one year', 'description': "Our primary outcomes will be patient level of satisfaction with the education they received prior to surgery and its impact on post-operative care which will be measured by the standardized likert scale (1 to 5 scale where 1 = strongly disagree and 5= strongly agree). The survey will include the following objective and subjective measures: Tylenol tablets used (over two weeks), Ibuprofen tablets used (over two weeks), pain scale (1 to 5 scale where 1 = none and 5= very severe). Additional information will be collected from the patient's medical records (ie. office visit notes, telephone encounters, hospital laboratory results, pain medication refill requests). Patients should continue any medication regimen as instructed by their physician up to the day of surgery. Patients will be treated for complications as they would have been treated otherwise. Study duration period will be approximately six months."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minimally invasive surgical procedures'], 'conditions': ['Gynecologic Laparoscopic Surgery', 'Minimally Invasive Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will evaluate the impact of a pre-operative instructional video for patients undergoing minimally invasive gynecologic surgery. The video will educate patients to understand what to expect and how to take care of themselves after the procedure. The effectiveness of the video will be evaluated via a questionnaire to see if patients who watched the video had better recovery outcomes, greater understanding, and less anxiety when compared to the group of patients who did not watch the pre-operative video.\n\nThe two questions the investigators wish to address are:\n\n1. Will the patients who watch the pre-operative will show decreased anxiety and uncertainty about their procedure when compared to the control group?\n2. Will increased understanding of the information shared in the video result in less pain medication usage, less ambiguity and thus increased compliance with post-operative care instructions, and quicker recovery?', 'detailedDescription': 'The study group of patients will be asked to watch the informational video about what to expect after their procedure and instructions on how to recover. They will be encouraged to ask their provider any follow-up questions. A link to view the video an unlimited amount of times will be provided. The control group of patients will receive the standard patient education in place before the procedure and will also be able to ask to follow-up questions from their provider. All patients will receive a link to complete a preoperative questionnaire.\n\nBoth groups will be scheduled for their routine two-week postoperative visit. At this visit, the questionnaire will be given to the patients in the form of a link to a virtual questionnaire to evaluate for effectiveness of the pre-operative video.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Participants/Sample Size: Female patients who have been recommended for minimally invasive gynecologic surgery. A total of 52 patients will be enrolled in this study at UCR Women's Health Clinic. Statistical power: To detect an effect size of 0.5 with a power of 0.8, a sample size of 52 participants was required.\n\nInclusion criteria:\n\n* Age 18 - 65 years old\n* Surgery with UCR Gynecology physician\n* Laparoscopic/robotic surgery\n* Same day discharge after surgery\n* Can read a survey in English\n* Female\n\nExclusion Criteria:\n\n* Receiving postoperative chemotherapy in the 6-week postoperative period\n* Minors under the age of 18\n* Postoperative overnight stay\n* Laparotomy (open surgery)\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT07364968', 'briefTitle': 'Impact of a Preoperative Instructional Video on Patient Preparedness', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Riverside'}, 'officialTitle': 'Evaluating the Impact of Randomized Preoperative Instructional Video on Patient Preparedness Following Minimally Invasive Gynecologic Surgery', 'orgStudyIdInfo': {'id': '23031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group of patients will be asked to watch an informational video.', 'description': 'They will be encouraged to ask their provider any follow-up questions. A link to view the video an unlimited amount of times will be provided.', 'interventionNames': ['Other: Study group of patients will receive standard of care']}, {'type': 'NO_INTERVENTION', 'label': 'Study group of patients will receive standard of care', 'description': 'The group of patients will receive the standard patient education in place before the procedure and will also be able to ask to follow-up questions from their provider. All patients will receive a link to complete a preoperative questionnaire.'}], 'interventions': [{'name': 'Study group of patients will receive standard of care', 'type': 'OTHER', 'description': 'The group of patients will receive the standard patient education in place before the procedure and will also be able to ask to follow-up questions from their provider.', 'armGroupLabels': ['Study group of patients will be asked to watch an informational video.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92521', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'University of Riverside, California', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant-level data will not be released. Only data aggregated to remove any identifiers will be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Riverside', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sarah Simko, M.D.', 'investigatorAffiliation': 'University of California, Riverside'}}}}