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

February 27, 2024 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital De Clinicas De Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiography impedance
Time Frame: 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).
28 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Ricardo Stein, PhD, Hospital De Clinicas De Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2015

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimated)

July 29, 2016

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-0598

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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