AzTrials
AzTrials

Ischaemic Heart DiseaseNCT02849067

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

A study testing Group Treatment in people with Ischaemic Heart Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Ischaemic Heart Disease
What is being tested?
Group Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteBrazil
Study dates
25 May 2015to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital De Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Group Treatment, Group Control
Keywords
ischaemic heart disease, comedy session, laughter therapy
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 ControlOther

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

Study groups in NCT02849067
Study groupRoleWhat they receive
Group TreatmentExperimentalPatients in this group will watch a comedy show that will will not exceed 30 minutes. This group will have until five patients.
Receives: Other: Group Treatment
Group ControlOtherpatients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients
Receives: Other: Group Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 28 weeks

Secondary outcomes (1)

  1. Humor

    it will be used the Humor Scale of Brunel

    Measured: 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2016 (estimated)
  2. Study start25 May 2015
  3. Primary completion30 Dec 2019
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02849067
Sponsor's protocol ID
14-0598
Status last verified
Feb 2024
First submitted
19 Jul 2016
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19261601

  • 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.

    PubMed 16415199

  • 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.

    PubMed 16786047

  • 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.

    PubMed 18317546

  • 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.

    PubMed 19251872

  • 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.

    PubMed 20816128

  • 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.

    PubMed 21641524

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

    PubMed 10497768

  • 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.

    PubMed 12432415

  • 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.

    PubMed 19477604

  • 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.

    PubMed 15032990

  • 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.

    PubMed 20664127

  • 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.

    PubMed 11253418

  • 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.

    PubMed 10496486

  • 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.

    PubMed 14258699

Questions about this trial

What is this clinical trial studying?

A study testing Group Treatment in people with Ischaemic Heart Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiography impedance (time frame: 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02849067, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in