Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT02849067
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiography impedance', 'timeFrame': '28 weeks', 'description': 'To assess the volumes and fluid passing through the chest at rest and during the exercise session will be used the Cardiography impedance device PhysioFlow, Enduro model (ManatecBiomedical, France).'}], 'secondaryOutcomes': [{'measure': 'Humor', 'timeFrame': '28 weeks', 'description': 'it will be used the Humor Scale of Brunel'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ischaemic heart disease', 'comedy session', 'laughter therapy'], 'conditions': ['Ischaemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '19261601', 'type': 'BACKGROUND', 'citation': 'Polanczyk CA, Ribeiro JP. Coronary artery disease in Brazil: contemporary management and future perspectives. Heart. 2009 Jun;95(11):870-6. doi: 10.1136/hrt.2008.155853. Epub 2009 Mar 3.'}, {'pmid': '16415199', 'type': 'BACKGROUND', 'citation': 'Miller M, Mangano C, Park Y, Goel R, Plotnick GD, Vogel RA. Impact of cinematic viewing on endothelial function. Heart. 2006 Feb;92(2):261-2. doi: 10.1136/hrt.2005.061424. No abstract available.'}, {'pmid': '16786047', 'type': 'BACKGROUND', 'citation': 'Bennett MP, Lengacher C. Humor and Laughter May Influence Health: II. Complementary Therapies and Humor in a Clinical Population. Evid Based Complement Alternat Med. 2006 Jun;3(2):187-90. doi: 10.1093/ecam/nel014. Epub 2006 Apr 24.'}, {'pmid': '18317546', 'type': 'BACKGROUND', 'citation': 'Bennett MP, Lengacher C. Humor and Laughter May Influence Health: III. Laughter and Health Outcomes. Evid Based Complement Alternat Med. 2008 Mar;5(1):37-40. doi: 10.1093/ecam/nem041.'}, {'pmid': '19251872', 'type': 'BACKGROUND', 'citation': 'Vlachopoulos C, Xaplanteris P, Alexopoulos N, Aznaouridis K, Vasiliadou C, Baou K, Stefanadi E, Stefanadis C. Divergent effects of laughter and mental stress on arterial stiffness and central hemodynamics. Psychosom Med. 2009 May;71(4):446-53. doi: 10.1097/PSY.0b013e318198dcd4. Epub 2009 Feb 27.'}, {'pmid': '20816128', 'type': 'BACKGROUND', 'citation': 'Sugawara J, Tarumi T, Tanaka H. Effect of mirthful laughter on vascular function. Am J Cardiol. 2010 Sep 15;106(6):856-9. doi: 10.1016/j.amjcard.2010.05.011.'}, {'pmid': '21641524', 'type': 'BACKGROUND', 'citation': 'Mora-Ripoll R. Potential health benefits of simulated laughter: a narrative review of the literature and recommendations for future research. Complement Ther Med. 2011 Jun;19(3):170-7. doi: 10.1016/j.ctim.2011.05.003. Epub 2011 May 25.'}, {'pmid': '10497768', 'type': 'BACKGROUND', 'citation': 'Bennett M, Lengacher C. Use of complementary therapies in a rural cancer population. Oncol Nurs Forum. 1999 Sep;26(8):1287-94.'}, {'pmid': '12432415', 'type': 'BACKGROUND', 'citation': 'Lengacher CA, Bennett MP, Kip KE, Keller R, LaVance MS, Smith LS, Cox CE. Frequency of use of complementary and alternative medicine in women with breast cancer. Oncol Nurs Forum. 2002 Nov-Dec;29(10):1445-52. doi: 10.1188/02.ONF.1445-1452.'}, {'pmid': '19477604', 'type': 'BACKGROUND', 'citation': 'Miller M, Fry WF. The effect of mirthful laughter on the human cardiovascular system. Med Hypotheses. 2009 Nov;73(5):636-9. doi: 10.1016/j.mehy.2009.02.044. Epub 2009 May 27.'}, {'pmid': '15032990', 'type': 'BACKGROUND', 'citation': 'Overeem S, Taal W, Ocal Gezici E, Lammers GJ, Van Dijk JG. Is motor inhibition during laughter due to emotional or respiratory influences? Psychophysiology. 2004 Mar;41(2):254-8. doi: 10.1111/j.1469-8986.2003.00145.x.'}, {'pmid': '20664127', 'type': 'BACKGROUND', 'citation': 'Tan SA, Tan LG, Lukman ST, Berk LS. Humor, as an adjunct therapy in cardiac rehabilitation, attenuates catecholamines and myocardial infarction recurrence. Adv Mind Body Med. 2007 Winter;22(3-4):8-12.'}, {'pmid': '11253418', 'type': 'BACKGROUND', 'citation': 'Berk LS, Felten DL, Tan SA, Bittman BB, Westengard J. Modulation of neuroimmune parameters during the eustress of humor-associated mirthful laughter. Altern Ther Health Med. 2001 Mar;7(2):62-72, 74-6.'}, {'pmid': '10496486', 'type': 'BACKGROUND', 'citation': 'Ishihara S, Nohara R, Makita S, Imai M, Kubo S, Hashimoto T. Immune function and psychological factors in patients with coronary heart disease (I). Jpn Circ J. 1999 Sep;63(9):704-9. doi: 10.1253/jcj.63.704.'}, {'pmid': '14258699', 'type': 'BACKGROUND', 'citation': 'LEVI L. THE URINARY OUTPUT OF ADRENALIN AND NORADRENALIN DURING PLEASANT AND UNPLEASANT EMOTIONAL STATES. A PRELIMINARY REPORT. Psychosom Med. 1965 Jan-Feb;27:80-5. doi: 10.1097/00006842-196501000-00009. No abstract available.'}, {'pmid': '16550224', 'type': 'BACKGROUND', 'citation': 'Bennett MP, Lengacher CA. Humor and laughter may influence health. I. History and background. Evid Based Complement Alternat Med. 2006 Mar;3(1):61-3. doi: 10.1093/ecam/nek015. Epub 2006 Jan 16.'}]}, 'descriptionModule': {'briefSummary': "It is known that laughter can bring benefits in terms of physiological and psychological parameters, in addition to improving the individual's quality of life. However, the literature is still scarce as to the existence of studies investigating the effects of a comedy film specifically in hemodynamics.", 'detailedDescription': 'Objective: To evaluate the effect of a comedy film session on the cardiac index, Systemic Vascular Resistance and Vascular Resistance Index Systemic in stable ischemic heart disease patients.\n\nMethod: Randomized Clinical Trial. Patients will be coming from Ischemic Heart Disease clinic at the Hospital de Clínicas de Porto Alegre (HCPA), all in regular monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages between 40 and 80 years\n* Both female and male\n* Diagnosis of ischemic heart disease by cardiac catheterization , with 50% lesion in at least one epicardial vessel\n\nExclusion Criteria:\n\n* Participants enrolled in another Randomized Clinical trial\n* Autoimmune diseases\n* Valvulopathy with mechanical or biological cardiac prosthesis\n* Presence of pacemakers and implantable cardioverter\n* Left bundle branch block in the electrocardiogram (ECG) of 12 derivations\n* Severe lung disease\n* Depression or Bipolar Disorder\n* Atrial Chronic Fibrillation\n* Left ventricular dysfunction (ejection fraction \\<45%)\n* Active Infection or neoplasia (not Basal cell carcinoma)\n* Chronic Renal Failure\n* Illiteracy and inability to understand the consent form'}, 'identificationModule': {'nctId': 'NCT02849067', 'briefTitle': 'Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '14-0598'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Treatment', 'description': 'Patients in this group will watch a comedy show that will will not exceed 30 minutes. This group will have until five patients.', 'interventionNames': ['Other: Group Treatment']}, {'type': 'OTHER', 'label': 'Group Control', 'description': 'patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients', 'interventionNames': ['Other: Group Control']}], 'interventions': [{'name': 'Group Treatment', 'type': 'OTHER', 'description': 'Patients in this group will watch a comedy show that will will not exceed 30 minutes. This group will have until five patients.', 'armGroupLabels': ['Group Treatment']}, {'name': 'Group Control', 'type': 'OTHER', 'description': 'patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients', 'armGroupLabels': ['Group Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital De Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Ricardo Stein, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}