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PainNCT02896075

Mirthful Laughter and Muscle Soreness / Pain

A study testing 30 Minute Comedy Video and 30 Minute Documentary Video in people with Pain, run by University of Texas at Austin at 1 site in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is first to investigate the effect of a controlled intervention with a comedy video on pain tolerance in a social setting while quantitatively measuring laughter in a young healthy population experiencing delayed onset muscle soreness. Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
30 Minute Comedy Video and 30 Minute Documentary Video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Aug 2016to 1 Sep 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Between the age of 20 and 40
  • Considered healthy

Who cannot join

  • Candidates that are on cardiovascular acting drugs.
  • Candidates currently taking anticoagulants.
  • Candidates that have chronic pain or other musculoskeletal injuries.
  • Candidates with a body fat percentage less than 5%.
  • Candidates with bleeding disorders or neurological disorders
  • Raynaud's disease
  • History of severe frost bite.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cardiovascular Aging Research Lab at UT Austin

    Austin, Texas, 78712

Other trials in United States

About this study

Official title: Social Laughter's Effect on Pain Tolerance

The purpose of this study is first to investigate the effect of a controlled intervention with a comedy video on pain tolerance in a social setting while quantitatively measuring laughter in a young healthy population experiencing delayed onset muscle soreness. The comedy intervention will be compared to a control of watching a documentary. The second aim is to examine to what extent various methods of eliciting pain would cause physiological responses that confound the interpretation of a pain stimulus.

Read the detailed description

Chronic pain affects 116 million people, that is more than the total affected by cardiovascular disease, cancer, and diabetes combined. Chronic pain has at least as large of a negative impact on quality of life as any other chronic disorder, and in the United States alone, the cost of chronic pain exceeds $635 billion per year. Interventions that effectively manage chronic pain are becoming increasingly important as the elderly population, who often suffer from osteoarthritis and low back pain, rises. Pain sensitivity and tolerance are impacted by a variety of affective factors. The laughter therapy is one of the most discussed and often controversial strategies for the management of pain. There are some preliminary uncontrolled studies reporting that pain tolerance is increased acutely with humor and laughter. Accordingly, the primary aim of the present study is to investigate the effect of a highly controlled intervention with a comedy video on pain tolerance and compare it to a control of watching a documentary video. Quantitatively measuring laughter with a chest stress-strain gauge during the interventions will allow the investigators to look for a possible dose response relationship. The investigators will use the pain and soreness felt from delayed onset muscle soreness (DOMS) in healthy subjects to simulate the condition of individuals suffering from chronic pain. This study will serve as a precursor to eventual studies specifically on individuals with chronic pain. If it can be proven that pain tolerance is increased in a healthy population than it is possible the intervention will have a greater affect in the chronic pain population.

Using healthy subjects with delayed onset muscle soreness allows the investigators to easily recruit and control for other diseases or disorders that may accompany a chronic pain individual.

There have been a number of different techniques used to assess pain tolerance. The modes of stimulating pain used in previous studies of laughter and humor on pain tolerance remain controversial. These studies utilized the cold pressor test and the inflation of a blood pressure cuff to elicit pain. Both of these methods are known to elicit marked cardiovascular responses along with the pain responses. An important part of the pain regulatory process in humans is that there is a functional interaction between the cardiovascular and pain regulatory systems. The brain regions underlying control of the cardiovascular system are known to overlap substantially with those that contribute to anti-nociception. Accordingly, it is difficult to determine how much of the pain tolerance is affected by cardiovascular reflexes. Thus, the secondary aim of the present study is to test how much cardiovascular responses will be elicited by a variety of methods of eliciting pain (pumping up a blood pressure cuff, the cold pressor test, and the application of blunt force on muscles).

The application of blunt force will be used to elicit pain without causing a systemic response involving cardiovascular reflexes which is seen in the cold pressor and inflation of a blood pressure cuff. The investigators believe these vast cardiovascular responses may cause pain tolerance to not be truly measured. It has been inferred that blunt force applied within a few seconds to a local, specific spot on the quadriceps will not stimulate a systemic and cardiovascular response and thus the pain tolerance measurement will be more accurate if independent of cardiovascular responses. Pressure and force application is widely used as an experimental pain stimulus, but it has not been utilized in the context of laughter and pain.

Conditions
Pain
Being tested
30 Minute Comedy Video, 30 Minute Documentary Video
Keywords
delayed onset muscle soreness, laughter
Medical subject headings
Pain, Laughter

What participants receive

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

  • 30 Minute Comedy VideoOther

    The intervention is a 30 minute video of a comedy

  • 30 Minute Documentary VideoOther

    The intervention is a 30 minute video of an uninteresting documentary

Study groups in NCT02896075
Study groupRoleWhat they receive
Randomized cross-over approachExperimentalThe main study was conducted using a randomized controlled cross-over approach. Participants made three visits each for the two video watching interventions. The interventions were separated by a minimum of 1week as a washout. Each intervention included one day of inducing muscle soreness in one leg through eccentric muscle contractions; a second day of testing muscle soreness and pain tolerance and watching a 30-min video (either a comedy or documentary); and a third day of testing muscle soreness and pain tolerance again to see if the effects of the video viewing persisted the next day (i.e., 24 h after the video viewing).
Receives: Other: 30 Minute Comedy Video; Other: 30 Minute Documentary Video

What is being measured

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

  1. Peak Force of Pain Tolerance Measurement

    The peak force is measured by using a force transducer and applying it to participants' quadriceps. Using data acquisition software the investigators can find the peak force applied.

    Measured: This was measured at 24 hours after watching either a comedy or documentary film.

Secondary outcomes (2)
  1. Heart Rate

    The heart rate was using a finger photoplethysmograph.

    Measured: This was measured at 24 hours after watching either a comedy or documentary video.

  2. Blood Pressure

    Blood pressure on the brachial artery measured via oscillometric methods

    Measured: This was measured at 24 hours after watching a comedy or documentary video.

Timeline

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

  1. First posted12 Sep 2016 (estimated)
  2. Study start1 Aug 2016
  3. Primary completion1 Sep 2017
  4. Study completion1 Sep 2017

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
The main study was conducted using a randomized controlled cross-over approach.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02896075
Sponsor's protocol ID
2016-05-0092
Status last verified
Apr 2021
First submitted
31 Aug 2016
Last updated
8 Apr 2021
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Lapierre SS, Baker BD, Tanaka H. Effects of mirthful laughter on pain tolerance: A randomized controlled investigation. J Bodyw Mov Ther. 2019 Oct;23(4):733-738. doi: 10.1016/j.jbmt.2019.04.005. Epub 2019 Apr 13.

    PubMed 31733755

Questions about this trial

What is this clinical trial studying?

A study testing 30 Minute Comedy Video and 30 Minute Documentary Video in people with Pain, run by University of Texas at Austin at 1 site in United States.

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 2 inclusion and 7 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 8 Apr 2021. 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 United States. 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?

Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Peak Force of Pain Tolerance Measurement (time frame: This was measured at 24 hours after watching either a comedy or documentary film.). 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 NCT02896075, which also lists 1 linked publication.

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 8 Apr 2021.

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