Clinical trial NCT02849067: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ischaemic Heart Disease
Keywords: ischaemic heart disease
comedy session
laughter therapy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cardiography impedance
timeFrame: 28 weeks
Secondary outcomes:
measure: Humor
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital De Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Ricardo Stein, PhD
role: PRINCIPAL_INVESTIGATOR
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