Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-01-10 @ 11:57 PM
Study NCT ID:
NCT03865459
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2019-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Watching Relaxing Video During Cystoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], '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': 'D020924', 'term': 'Urological Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-10', 'studyFirstSubmitDate': '2019-03-04', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change on pain intensity as measured by Visual Analog Scale', 'timeFrame': '"5-10 minutes before", "during" and "5 minutes after" cytoscopy.', 'description': 'The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm (0-100 mm). High scores on the scale indicate that pain intensity is high.'}], 'secondaryOutcomes': [{'measure': 'score change on anxiety level as measured by State-Trait Anxiety Inventory', 'timeFrame': '"5-10 minutes before" and "5 minutes after" cytoscopy.', 'description': 'The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale is used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety', 'cystoscopy', 'female', 'nursing', 'pain', 'video'], 'conditions': ['Pain', 'Anxiety', 'Urological Nursing', 'Lower Urinary Tract Symptoms']}, 'referencesModule': {'references': [{'pmid': '12861140', 'type': 'BACKGROUND', 'citation': 'Ellerkmann RM, Dunn JS, McBride AW, Kummer LG, Melick CF, Bent AE, Blomquist JL. A comparison of anticipated pain before and pain rating after the procedure in patients who undergo cystourethroscopy. Am J Obstet Gynecol. 2003 Jul;189(1):66-9. doi: 10.1067/mob.2003.377.'}, {'pmid': '15118637', 'type': 'BACKGROUND', 'citation': 'Ellerkmann RM, McBride AW, Dunn JS, Bent AE, Blomquist JL, Kummer LG, Melick CF. A comparison of anticipatory and postprocedure pain perception in patients who undergo urodynamic procedures. Am J Obstet Gynecol. 2004 Apr;190(4):1034-8. doi: 10.1016/j.ajog.2003.11.006.'}, {'pmid': '30280915', 'type': 'BACKGROUND', 'citation': 'Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491.'}, {'pmid': '25251958', 'type': 'BACKGROUND', 'citation': 'Greenstein A, Greenstein I, Senderovich S, Mabjeesh NJ. Is diagnostic cystoscopy painful? Analysis of 1,320 consecutive procedures. Int Braz J Urol. 2014 Jul-Aug;40(4):533-8. doi: 10.1590/S1677-5538.IBJU.2014.04.13.'}, {'pmid': '14616460', 'type': 'BACKGROUND', 'citation': 'Kesari D, Kovisman V, Cytron S, Benjamin J. Effects on pain and anxiety of patients viewing their cystoscopy in addition to a detailed explanation: a controlled study. BJU Int. 2003 Nov;92(7):751-2. doi: 10.1046/j.1464-410x.2003.04477.x.'}, {'pmid': '25630866', 'type': 'BACKGROUND', 'citation': 'Raheem OA, Mirheydar HS, Lee HJ, Patel ND, Godebu E, Sakamoto K. Does Listening to Music During Office-Based Flexible Cystoscopy Decrease Anxiety in Patients: A Prospective Randomized Trial. J Endourol. 2015 Jul;29(7):791-6. doi: 10.1089/end.2015.0029. Epub 2015 Apr 13.'}, {'pmid': '20974485', 'type': 'BACKGROUND', 'citation': "Soomro KQ, Nasir AR, Ather MH. Impact of patient's self-viewing of flexible cystoscopy on pain using a visual analog scale in a randomized controlled trial. Urology. 2011 Jan;77(1):21-3. doi: 10.1016/j.urology.2010.08.012. Epub 2010 Oct 25."}, {'pmid': '25102532', 'type': 'BACKGROUND', 'citation': 'Walker MR, Kallingal GJ, Musser JE, Folen R, Stetz MC, Clark JY. Treatment efficacy of virtual reality distraction in the reduction of pain and anxiety during cystoscopy. Mil Med. 2014 Aug;179(8):891-6. doi: 10.7205/MILMED-D-13-00343.'}, {'pmid': '23009573', 'type': 'BACKGROUND', 'citation': 'Yeo JK, Cho DY, Oh MM, Park SS, Park MG. Listening to music during cystoscopy decreases anxiety, pain, and dissatisfaction in patients: a pilot randomized controlled trial. J Endourol. 2013 Apr;27(4):459-62. doi: 10.1089/end.2012.0222. Epub 2012 Dec 5.'}, {'pmid': '24548148', 'type': 'BACKGROUND', 'citation': 'Zhang ZS, Wang XL, Xu CL, Zhang C, Cao Z, Xu WD, Wei RC, Sun YH. Music reduces panic: an initial study of listening to preferred music improves male patient discomfort and anxiety during flexible cystoscopy. J Endourol. 2014 Jun;28(6):739-44. doi: 10.1089/end.2013.0705. Epub 2014 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'The cystoscopy procedure may cause pain and anxiety in patients. Since cystoscopy causes more pain in men, studies on pain and anxiety during cystoscopy are more common in men than women. The aim of this study was to evaluate the effect of watching relaxing video during cystoscopy on the pain and anxiety levels of female patients.', 'detailedDescription': "Cystoscopy is a safe procedure with low risk of morbidity commonly used to evaluate lower urinary tract symptoms such as hematuria, voiding disorders, irritant bladder symptoms, anatomical disorders. Patients experience pain and anxiety when cystoscope is inserted into the bladder. The various methods (drug or non-drug) are used for pain and anxiety during the cystoscopy. Although there are a lot of studies on male patients, there are limited studies evaluating pain severity in the female patients during urological procedures. In addition, there wasn't found any randomized controlled study for video use from non-drug methods to distract attention in these patients. Based on the study results in the literature, investigators aimed to evaluate the effect of watching relaxing video on the pain and anxiety levels of female patients during rigid cystoscopy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* female gender\n* rigid cystoscopy for the first time\n\nExclusion Criteria:\n\n* presence of any contraindication for cystoscopy (such as lidocaine allergy, urinary tract infection, and urethra-related anatomical disorders)\n* any analgesic used 24 hours before cystoscopy\n* manipulations such as Double-J stent placement or removal, and/or bladder biopsy.'}, 'identificationModule': {'nctId': 'NCT03865459', 'briefTitle': 'The Effect of Watching Relaxing Video During Cystoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}, 'officialTitle': 'The Effect of Watching Relaxing Video on Pain and Anxiety Levels of Female Patients During Cystoscopy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '46418926'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video group', 'description': 'The video group watched relaxing video with a ceiling mounted television during the whole cystoscopy.', 'interventionNames': ['Other: Video group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "The control group received the standard treatment from a surgical technician who works in the cystoscopy during the whole procedure.The control group didn't watch relaxing video during the procedure."}], 'interventions': [{'name': 'Video group', 'type': 'OTHER', 'description': 'Patients in the video group started to watch the relaxing video about 5-10 minutes before cystoscopy, and continued to watch video during the whole procedure.', 'armGroupLabels': ['Video group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elif Gezginci', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}}}}