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

Not Applicable

Completed

• Conditions: Ischaemic Heart Disease
• Interventions: Other: Group Treatment; Other: Group Control

• Registration Number: NCT02849067
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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 Timeline

• Study Start: 2015-05-25
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-07-29
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Treatment	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.
Group Control	Group Control	patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Humor	28 weeks	it will be used the Humor Scale of Brunel

Trial Locations

Locations (1)

Hospital De Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil