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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

Tracking Information
First Submitted Date  ICMJE July 19, 2016
First Posted Date  ICMJE July 29, 2016
Last Update Posted Date July 29, 2016
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
Humor [ Time Frame: 28 weeks ]
it will be used the Humor Scale of Brunel
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session
Official Title  ICMJE Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session: Randomized Controlled Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischaemic Heart Disease
Intervention  ICMJE
  • 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.
  • Other: Group Control
    patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients
Study Arms  ICMJE
  • 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.
    Intervention: Other: Group Treatment
  • Group Control
    patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients
    Intervention: Other: Group Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 28, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02849067
Other Study ID Numbers  ICMJE 14-0598
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ricardo Stein, PhD Hospital de Clínicas de Porto Alegre
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP