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

Study Overview
=================
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.

Official Title
-----------------
Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session: Randomized Controlled Trial

Conditions
-----------------
Ischaemic Heart Disease

Intervention / Treatment
-----------------
* Other: Group Treatment
* Other: Group Control


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Treatment<br>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<br>* Patients in this group will watch a comedy show that will will not exceed 30 minutes. This group will have until five patients.<br>|
| Other: Group Control<br>patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients | Other: Group Control<br>* patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humor | it will be used the Humor Scale of Brunel | 28 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischaemic heart disease, comedy session, laughter therapy