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

Primary Purpose

Ischaemic Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Group Treatment
Group Control
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischaemic Heart Disease focused on measuring ischaemic heart disease, comedy session, laughter therapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital De Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group Treatment

Group Control

Arm Description

Patients in this group will watch a comedy show that will will not exceed 30 minutes. This group will have until five patients.

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

Outcomes

Primary Outcome Measures

Cardiography impedance
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

Humor
it will be used the Humor Scale of Brunel

Full Information

First Posted
July 19, 2016
Last Updated
July 28, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02849067
Brief Title
Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session
Official Title
Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischaemic Heart Disease
Keywords
ischaemic heart disease, comedy session, laughter therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Treatment
Arm Type
Experimental
Arm Description
Patients in this group will watch a comedy show that will will not exceed 30 minutes. This group will have until five patients.
Arm Title
Group Control
Arm Type
Other
Arm Description
patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients
Intervention Type
Other
Intervention Name(s)
Group Treatment
Intervention Description
Patients in this group will watch a comedy show that will will not exceed 30 minutes. This group will have until five patients.
Intervention Type
Other
Intervention Name(s)
Group Control
Intervention Description
patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients
Primary Outcome Measure Information:
Title
Cardiography impedance
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).
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Humor
Description
it will be used the Humor Scale of Brunel
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosane M Nery, PhD
Phone
0555133597634
Email
rosane.nery@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Raquel P Buhler, MD
Phone
0555133597634
Email
rpbuhler@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Stein, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital De Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel P Bühler, MD
Phone
555133597634
Email
rpbuhler@gmail.com
First Name & Middle Initial & Last Name & Degree
Rosane M Nery, PhD
Phone
555133597634
Email
rosane.nery@gmail.com
First Name & Middle Initial & Last Name & Degree
Ricardo Stein, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Citation
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Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session

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