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

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Unknown status
CT.gov ID
NCT02849067
Collaborator
(none)
36
1
2
24
1.5

Study Details

Study Description

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
  • Other: Group Treatment
  • Other: Group Control
N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2015
Anticipated Primary Completion Date :
Mar 1, 2017
Anticipated Study Completion Date :
Mar 1, 2017

Arms and Interventions

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.

Other: 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

Outcome Measures

Primary Outcome Measures

  1. Cardiography impedance [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 [28 weeks]

    it will be used the Humor Scale of Brunel

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital De Clínicas de Porto Alegre Porto Alegre Rio Grande do Sul Brazil 90035-903

Sponsors and Collaborators

  • Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Ricardo Stein, PhD, Hospital de Clínicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT02849067
Other Study ID Numbers:
  • 14-0598
First Posted:
Jul 29, 2016
Last Update Posted:
Jul 29, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2016