NCT02849067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4.6 years

First QC Date

July 19, 2016

Last Update Submit

February 27, 2024

Conditions

Ischaemic Heart Disease

Keywords

ischaemic heart diseasecomedy sessionlaughter therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Humor

    28 weeks

Study Arms (2)

Group Treatment

EXPERIMENTAL

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

Group Control

OTHER

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

Other: Group Control

Interventions

Group TreatmentOTHER

Patients in this group will watch a comedy show that will will not exceed 30 minutes. This group will have until five patients.

Group Treatment
Group ControlOTHER

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

Group Control

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital De Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (16)

  • 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.

    PMID: 19261601BACKGROUND

  • 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.

    PMID: 16415199BACKGROUND

  • 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.

    PMID: 16786047BACKGROUND

  • 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.

    PMID: 18317546BACKGROUND

  • 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.

    PMID: 19251872BACKGROUND

  • 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.

    PMID: 20816128BACKGROUND

  • 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.

    PMID: 21641524BACKGROUND

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

    PMID: 10497768BACKGROUND

  • 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.

    PMID: 12432415BACKGROUND

  • 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.

    PMID: 19477604BACKGROUND

  • 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.

    PMID: 15032990BACKGROUND

  • 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.

    PMID: 20664127BACKGROUND

  • 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.

    PMID: 11253418BACKGROUND

  • 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.

    PMID: 10496486BACKGROUND

  • 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.

    PMID: 14258699BACKGROUND

  • 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.

    PMID: 16550224BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ricardo Stein, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 29, 2016

Study Start

May 25, 2015

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

BR(1)