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Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session

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ClinicalTrials.gov Identifier: NCT02849067
Recruitment Status : Unknown
Verified July 2016 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ischaemic Heart Disease Other: Group Treatment Other: Group Control Not Applicable

Detailed Description:

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.

Method: 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session: Randomized Controlled Trial
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group Treatment
Patients in this group will watch a comedy show that will will not exceed 30 minutes. This group will have until five patients.
Other: Group Treatment
Patients in this group will watch a comedy show that will will not exceed 30 minutes. This group will have until five patients.

Group Control
patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients
Other: Group Control
patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients




Primary Outcome Measures :
  1. Cardiography impedance [ Time Frame: 28 weeks ]
    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).


Secondary Outcome Measures :
  1. Humor [ Time Frame: 28 weeks ]
    it will be used the Humor Scale of Brunel



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages between 40 and 80 years
  • Both female and male
  • Diagnosis of ischemic heart disease by cardiac catheterization , with 50% lesion in at least one epicardial vessel

Exclusion Criteria:

  • Participants enrolled in another Randomized Clinical trial
  • Autoimmune diseases
  • Valvulopathy with mechanical or biological cardiac prosthesis
  • Presence of pacemakers and implantable cardioverter
  • Left bundle branch block in the electrocardiogram (ECG) of 12 derivations
  • Severe lung disease
  • Depression or Bipolar Disorder
  • Atrial Chronic Fibrillation
  • Left ventricular dysfunction (ejection fraction <45%)
  • Active Infection or neoplasia (not Basal cell carcinoma)
  • Chronic Renal Failure
  • Illiteracy and inability to understand the consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849067


Contacts
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Contact: Rosane M Nery, PhD 0555133597634 rosane.nery@gmail.com
Contact: Raquel P Buhler, MD 0555133597634 rpbuhler@gmail.com

Locations
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Brazil
Hospital De Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Raquel P Bühler, MD    555133597634    rpbuhler@gmail.com   
Contact: Rosane M Nery, PhD    555133597634    rosane.nery@gmail.com   
Principal Investigator: Ricardo Stein, PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Ricardo Stein, PhD Hospital de Clínicas de Porto Alegre

Publications:

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02849067     History of Changes
Other Study ID Numbers: 14-0598
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hospital de Clinicas de Porto Alegre:
ischaemic heart disease
comedy session
laughter therapy

Additional relevant MeSH terms:
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Ischemia
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases