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

Ischaemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849067
• Other study ID #: 14-0598
• Status: Completed
• Phase: N/A
• Start date: May 25, 2015
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2024
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischaemic Heart Disease
• Ischemia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital De Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (16)

Bennett M, Lengacher C. Use of complementary therapies in a rural cancer population. Oncol Nurs Forum. 1999 Sep;26(8):1287-94. — View Citation

Bennett MP, Lengacher C. Humor and Laughter May Influence Health: II. Complementary Therapies and Humor in a Clinical Population. Evid Based Complement Alternat Med. 2006 Jun;3(2):187-90. doi: 10.1093/ecam/nel014. Epub 2006 Apr 24. — View Citation

Bennett MP, Lengacher C. Humor and Laughter May Influence Health: III. Laughter and Health Outcomes. Evid Based Complement Alternat Med. 2008 Mar;5(1):37-40. doi: 10.1093/ecam/nem041. — View Citation

Bennett MP, Lengacher CA. Humor and laughter may influence health. I. History and background. Evid Based Complement Alternat Med. 2006 Mar;3(1):61-3. doi: 10.1093/ecam/nek015. Epub 2006 Jan 16. — View Citation

Berk LS, Felten DL, Tan SA, Bittman BB, Westengard J. Modulation of neuroimmune parameters during the eustress of humor-associated mirthful laughter. Altern Ther Health Med. 2001 Mar;7(2):62-72, 74-6. — View Citation

Ishihara S, Nohara R, Makita S, Imai M, Kubo S, Hashimoto T. Immune function and psychological factors in patients with coronary heart disease (I). Jpn Circ J. 1999 Sep;63(9):704-9. doi: 10.1253/jcj.63.704. — View Citation

Lengacher CA, Bennett MP, Kip KE, Keller R, LaVance MS, Smith LS, Cox CE. Frequency of use of complementary and alternative medicine in women with breast cancer. Oncol Nurs Forum. 2002 Nov-Dec;29(10):1445-52. doi: 10.1188/02.ONF.1445-1452. — View Citation

LEVI L. THE URINARY OUTPUT OF ADRENALIN AND NORADRENALIN DURING PLEASANT AND UNPLEASANT EMOTIONAL STATES. A PRELIMINARY REPORT. Psychosom Med. 1965 Jan-Feb;27:80-5. doi: 10.1097/00006842-196501000-00009. No abstract available. — View Citation

Miller M, Fry WF. The effect of mirthful laughter on the human cardiovascular system. Med Hypotheses. 2009 Nov;73(5):636-9. doi: 10.1016/j.mehy.2009.02.044. Epub 2009 May 27. — View Citation

Miller M, Mangano C, Park Y, Goel R, Plotnick GD, Vogel RA. Impact of cinematic viewing on endothelial function. Heart. 2006 Feb;92(2):261-2. doi: 10.1136/hrt.2005.061424. No abstract available. — View Citation

Mora-Ripoll R. Potential health benefits of simulated laughter: a narrative review of the literature and recommendations for future research. Complement Ther Med. 2011 Jun;19(3):170-7. doi: 10.1016/j.ctim.2011.05.003. Epub 2011 May 25. — View Citation

Overeem S, Taal W, Ocal Gezici E, Lammers GJ, Van Dijk JG. Is motor inhibition during laughter due to emotional or respiratory influences? Psychophysiology. 2004 Mar;41(2):254-8. doi: 10.1111/j.1469-8986.2003.00145.x. — View Citation

Polanczyk CA, Ribeiro JP. Coronary artery disease in Brazil: contemporary management and future perspectives. Heart. 2009 Jun;95(11):870-6. doi: 10.1136/hrt.2008.155853. Epub 2009 Mar 3. — View Citation

Sugawara J, Tarumi T, Tanaka H. Effect of mirthful laughter on vascular function. Am J Cardiol. 2010 Sep 15;106(6):856-9. doi: 10.1016/j.amjcard.2010.05.011. — View Citation

Tan SA, Tan LG, Lukman ST, Berk LS. Humor, as an adjunct therapy in cardiac rehabilitation, attenuates catecholamines and myocardial infarction recurrence. Adv Mind Body Med. 2007 Winter;22(3-4):8-12. — View Citation

Vlachopoulos C, Xaplanteris P, Alexopoulos N, Aznaouridis K, Vasiliadou C, Baou K, Stefanadi E, Stefanadis C. Divergent effects of laughter and mental stress on arterial stiffness and central hemodynamics. Psychosom Med. 2009 May;71(4):446-53. doi: 10.1097/PSY.0b013e318198dcd4. Epub 2009 Feb 27. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Humor	it will be used the Humor Scale of Brunel	28 weeks