Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-27 @ 7:31 PM
Study NCT ID:
NCT04971057
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2021-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimedia Information for Patients With Renal Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D006417', 'term': 'Hematuria'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General Self-Efficacy Scale', 'timeFrame': 'pretest', 'description': 'A total of 10 items. A 4-point(1-4) scoring method was adopted. Higher scores indicate higher self-efficacy'}, {'measure': 'General Self-Efficacy Scale', 'timeFrame': 'post-operative day 9', 'description': 'A total of 10 items. A 4-point(1-4) scoring method was adopted. Higher scores indicate higher self-efficacy'}, {'measure': 'Pain Visual Analogy Scale', 'timeFrame': 'pretest', 'description': 'It is an actual straight line of 100 mm, of which 0 mm means no pain at all and 100 mm means extreme pain. A higher score indicates greater pain intensity'}, {'measure': 'Pain Visual Analogy Scale', 'timeFrame': 'pre-operation', 'description': 'It is an actual straight line of 100 mm, of which 0 mm means no pain at all and 100 mm means extreme pain. A higher score indicates greater pain intensity.'}, {'measure': 'Pain Visual Analogy Scale', 'timeFrame': 'post-operative day 1', 'description': 'It is an actual straight line of 100 mm, of which 0 mm means no pain at all and 100 mm means extreme pain. A higher score indicates greater pain intensity.'}, {'measure': 'Pain Visual Analogy Scale', 'timeFrame': 'post-operative day 9', 'description': 'It is an actual straight line of 100 mm, of which 0 mm means no pain at all and 100 mm means extreme pain. A higher score indicates greater pain intensity.'}, {'measure': 'Visual Analogue Scale for Anxiety', 'timeFrame': 'pretest', 'description': 'It is an actual straight line of 100 mm, of which 0 mm means no anxiety at all and 100 mm means extreme anxiety. A higher score indicates greater severity of anxiety'}, {'measure': 'Visual Analogue Scale for Anxiety', 'timeFrame': 'pre-operation', 'description': 'It is an actual straight line of 100 mm, of which 0 mm means no anxiety at all and 100 mm means extreme anxiety. A higher score indicates greater severity of anxiety'}, {'measure': 'Visual Analogue Scale for Anxiety', 'timeFrame': 'post-operative day 1', 'description': 'It is an actual straight line of 100 mm, of which 0 mm means no anxiety at all and 100 mm means extreme anxiety. A higher score indicates greater severity of anxiety'}, {'measure': 'Visual Analogue Scale for Anxiety', 'timeFrame': 'post-operative day 9', 'description': 'It is an actual straight line of 100 mm, of which 0 mm means no anxiety at all and 100 mm means extreme anxiety. A higher score indicates greater severity of anxiety'}], 'secondaryOutcomes': [{'measure': 'Positive and Negative Affective Scale', 'timeFrame': 'pretest', 'description': 'It contains a total of 20 items with two subscales including positive affective subscale and negative affective subscale. A 4-point (1-4) scoring method is used. Higher scores represent higher levels of positive and negative affect'}, {'measure': 'Positive and Negative Affective Scale', 'timeFrame': 'post-operative day 9', 'description': 'It contains a total of 20 items with two subscales including positive affective subscale and negative affective subscale. A 4-point (1-4) scoring method is used. Higher scores represent higher levels of positive and negative affect'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multimedia information', 'renal biopsy', 'self-efficacy', 'pain', 'anxiety', 'positive and negative affective', 'hematuria'], 'conditions': ['Pain', 'Anxiety', 'Hematuria']}, 'referencesModule': {'references': [{'pmid': '32489494', 'type': 'BACKGROUND', 'citation': 'Akca A, Yilmaz G, Esmer AC, Yuksel S, Koroglu N, Cetin BA. Use of video-based multimedia information to reduce anxiety before office hysteroscopy. Wideochir Inne Tech Maloinwazyjne. 2020 Jun;15(2):329-336. doi: 10.5114/wiitm.2019.89378. Epub 2019 Oct 28.'}, {'pmid': '24812709', 'type': 'BACKGROUND', 'citation': 'Batuyong ED, Jowett AJ, Wickramasinghe N, Beischer AD. Using multimedia to enhance the consent process for bunion correction surgery. ANZ J Surg. 2014 Apr;84(4):249-54. doi: 10.1111/ans.12534.'}, {'pmid': '26464072', 'type': 'BACKGROUND', 'citation': 'Bowers N, Eisenberg E, Montbriand J, Jaskolka J, Roche-Nagle G. Using a multimedia presentation to improve patient understanding and satisfaction with informed consent for minimally invasive vascular procedures. Surgeon. 2017 Feb;15(1):7-11. doi: 10.1016/j.surge.2015.09.001. Epub 2015 Oct 14.'}, {'pmid': '25374824', 'type': 'BACKGROUND', 'citation': 'Brachemi S, Bollee G. Renal biopsy practice: What is the gold standard? World J Nephrol. 2014 Nov 6;3(4):287-94. doi: 10.5527/wjn.v3.i4.287.'}, {'pmid': '24957046', 'type': 'BACKGROUND', 'citation': 'Chung S, Koh ES, Kim SJ, Yoon HE, Park CW, Chang YS, Shin SJ. Safety and tissue yield for percutaneous native kidney biopsy according to practitioner and ultrasound technique. BMC Nephrol. 2014 Jun 23;15:96. doi: 10.1186/1471-2369-15-96.'}, {'pmid': '26856480', 'type': 'BACKGROUND', 'citation': 'Demircelik MB, Cakmak M, Nazli Y, Sentepe E, Yigit D, Keklik M, Arslan M, Cetin M, Eryonucu B. Effects of multimedia nursing education on disease-related depression and anxiety in patients staying in a coronary intensive care unit. Appl Nurs Res. 2016 Feb;29:5-8. doi: 10.1016/j.apnr.2015.03.014. Epub 2015 Apr 7.'}, {'pmid': '26777257', 'type': 'BACKGROUND', 'citation': "D'Souza V, Blouin E, Zeitouni A, Muller K, Allison PJ. Multimedia information intervention and its benefits in partners of the head and neck cancer patients. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12440. Epub 2016 Jan 18."}, {'pmid': '24462856', 'type': 'BACKGROUND', 'citation': 'Ellett L, Villegas R, Beischer A, Ong N, Maher P. Use of a multimedia module to aid the informed consent process in patients undergoing gynecologic laparoscopy for pelvic pain: randomized controlled trial. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):602-11. doi: 10.1016/j.jmig.2014.01.002. Epub 2014 Jan 23.'}, {'pmid': '28352011', 'type': 'BACKGROUND', 'citation': 'El-Reshaid K, El-Reshaid W, Al-Bader D, Varro J, Madda J, Sallam HT. Biopsy of small kidneys: A safe and a useful guide to potentially treatable kidney disease. Saudi J Kidney Dis Transpl. 2017 Mar-Apr;28(2):298-306. doi: 10.4103/1319-2442.202767.'}, {'pmid': '26379073', 'type': 'BACKGROUND', 'citation': 'Hirsch JK, Sirois FM, Molnar D, Chang EC. Pain and Depressive Symptoms in Primary Care: Moderating Role of Positive and Negative Affect. Clin J Pain. 2016 Jul;32(7):562-7. doi: 10.1097/AJP.0000000000000292.'}, {'pmid': '26551213', 'type': 'BACKGROUND', 'citation': 'Hsueh FC, Chen CM, Sun CA, Chou YC, Hsiao SM, Yang T. A Study on the Effects of a Health Education Intervention on Anxiety and Pain During Colonoscopy Procedures. J Nurs Res. 2016 Jun;24(2):181-9. doi: 10.1097/jnr.0000000000000112.'}, {'pmid': '27631225', 'type': 'BACKGROUND', 'citation': 'Hu T, Liu Q, Xu Q, Liu H, Feng Y, Qiu W, Huang F, Lv Y. Absorption fever characteristics due to percutaneous renal biopsy-related hematoma. Medicine (Baltimore). 2016 Sep;95(37):e4754. doi: 10.1097/MD.0000000000004754.'}, {'pmid': '30825408', 'type': 'BACKGROUND', 'citation': 'Karadag E. The effect of a self-management program on hand-washing/mask-wearing behaviours and self-efficacy level in peritoneal dialysis patients: a pilot study. J Ren Care. 2019 Jun;45(2):93-101. doi: 10.1111/jorc.12270. Epub 2019 Mar 2.'}, {'pmid': '27456461', 'type': 'BACKGROUND', 'citation': 'Kauric-Klein Z, Peters RM, Yarandi HN. Self-Efficacy and Blood Pressure Self-Care Behaviors in Patients on Chronic Hemodialysis. West J Nurs Res. 2017 Jul;39(7):886-905. doi: 10.1177/0193945916661322. Epub 2016 Jul 24.'}, {'pmid': '25394450', 'type': 'BACKGROUND', 'citation': 'Mohammed A, Manjanabil P, deTakats D. Retroperitoneum: a forgotten and fatal aspect of kidney biopsy. Saudi J Kidney Dis Transpl. 2014 Nov;25(6):1278-81. doi: 10.4103/1319-2442.144267.'}]}, 'descriptionModule': {'briefSummary': 'This study takes place in the Divisions of Nephrology. Patients undergoing renal biopsy were randomized to control group or multimedia information intervention group. The control group received routine care, and the multimedia information intervention group received a multimedia information. After the pre-test, the two groups performed the 1 to 3 post-tests on pre-operation, post-operative day 1 and post-operative day 9. This study used questionnaires that including General Self-Efficacy Scale, Pain Visual Analogy Scale, Visual Analogue Scale for Anxiety, and Positive and Negative Affective Scale.', 'detailedDescription': 'This study takes place in the Divisions of Nephrology at Chang Gung Memorial Hospitals. Patients undergoing renal biopsy were randomized to control group or multimedia information intervention group. The control group received routine care, and the multimedia information intervention group received a multimedia information. Multimedia information intervention is based on self-efficacy theory. The multimedia videos contain the information associated with renal biopsy, which including the purpose, indications, preparations for the examination, process, patient experience sharing, complications, precautions, home care and stress adjustment strategies. In addition, the investigator also provide face-to-face consultations on answers and clarifications for the content of the videos and telephone consultations to understand the self-care situation of patients on the third day after discharge. After the pre-test, the two groups performed the 1 to 3 post-tests on pre-operation, post-operative day 1 and post-operative day 9. This study used questionnaires that including General Self-Efficacy Scale, Pain Visual Analogy Scale, Visual Analogue Scale for Anxiety, and Positive and Negative Affective Scale. Generalized Estimating Equations (GEEs) will be used to o analyze data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients are at least 20 years old\n2. patients need to undergo a renal biopsy\n3. patients can communicate in Chinese or Taiwanese\n4. patients agree to participate in the research and sign the consent form\n5. patients have family members accompanying\n\nExclusion Criteria:\n\n1. patients have undergone renal biopsy before\n2. patients have history of mental disorder\n3. patients use anticoagulants'}, 'identificationModule': {'nctId': 'NCT04971057', 'briefTitle': 'Multimedia Information for Patients With Renal Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'National Taipei University of Nursing and Health Sciences'}, 'officialTitle': 'The Effects of Multimedia Information for Patients With Renal Biopsy', 'orgStudyIdInfo': {'id': '201900682B0C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group received routine care'}, {'type': 'EXPERIMENTAL', 'label': 'Multimedia information Group', 'description': 'The experimental group received a multimedia information', 'interventionNames': ['Other: multimedia information program of renal biopsy']}], 'interventions': [{'name': 'multimedia information program of renal biopsy', 'type': 'OTHER', 'description': 'Multimedia information program is based on self-efficacy theory. The multimedia videos contain the information associated with renal biopsy, which including the purpose, indications, preparations for the examination, process, patient experience sharing, complications, precautions, home care and stress adjustment strategies.', 'armGroupLabels': ['Multimedia information Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital at Linkou', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taipei University of Nursing and Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ching-Hui Chien', 'investigatorAffiliation': 'National Taipei University of Nursing and Health Sciences'}}}}