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CompletedNCT02896075Updated Apr 8, 2021Results posted

Mirthful Laughter and Muscle Soreness / Pain

An interventional study of 30 Minute Comedy Video and 30 Minute Documentary Video in Pain, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-08.

Sponsored by University of Texas at Austin · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pain

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Keywords

  • delayed onset muscle soreness
  • laughter
03

In context

Myalgia

282 studies on the registry are indexed under Myalgia; 43 are open to participants now.

This study's enrollment of 40 is close to the median of 44 across 241 interventional studies indexed under Myalgia.

Browse Myalgia studies →

Lead sponsor

University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Between the age of 20 and 40
  • Considered healthy

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Randomized cross-over approach

    The 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).

    Other: 30 Minute Comedy Video · Other: 30 Minute Documentary Video

Interventions

  • Other30 Minute Comedy Video

    The intervention is a 30 minute video of a comedy

  • Other30 Minute Documentary Video

    The intervention is a 30 minute video of an uninteresting documentary

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  1. Heart Rate

    The heart rate was using a finger photoplethysmograph.

    Time frame: 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

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

07

Results

Posted Apr 8, 2021

Participant flow

Participants were recruited from the University student body and the city surrounding the university using flyers

Participant flow — Overall Study
MilestoneAll Study Participants Acting Their Own Controls
Started40
Leg soreness40
Completed40
Not completed0

Outcome measures

PrimaryPeak 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.

Time frame:
This was measured at 24 hours after watching either a comedy or documentary film.
Reported as:
Mean · N
Peak Force of Pain Tolerance Measurement
NComedy VideoDocumentary Watching
Peak Force of Pain Tolerance Measurement2 ± 321 ± 5
SecondaryHeart Rate

The heart rate was using a finger photoplethysmograph.

Time frame:
This was measured at 24 hours after watching either a comedy or documentary video.
Reported as:
Mean · beats/minutres
Heart Rate
beats/minutresComedy WatchingDocumentary Watching
Heart Rate67 ± 1266 ± 13
SecondaryBlood Pressure

Blood pressure on the brachial artery measured via oscillometric methods

Time frame:
This was measured at 24 hours after watching a comedy or documentary video.
Reported as:
Mean · mmHg
Blood Pressure
mmHgComedy WatchingDocumentary Watching
Systolic blood pressure116 ± 10116 ± 10
Diastolic blood pressure57 ± 757 ± 7

Adverse events

Collected over ~9 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Leg With and Without Delayed Onset Muscle Soreness0/20 (0%)0/20 (0%)0/20 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)All Study Participants
<=18 years0
Between 18 and 65 years40
>=65 years0
Age, Continuous
Age, Continuous(years)All Study Participants
Mean23 ± 4
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female25
Male15
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Study Participants
American Indian or Alaska Native0
Asian10
Native Hawaiian or Other Pacific Islander0
Black or African American2
White27
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)All Study Participants
United States40
08

Study locations

1 site
  • Cardiovascular Aging Research Lab at UT Austin
    Austin, Texas 78712, United States
09

References and documents

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 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 7, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02896075
Lead sponsor
University of Texas at Austin
Responsible party
Sponsor
First posted
Sep 12, 2016
Start date
Aug 1, 2016
Primary completion
Sep 1, 2017
Completion
Sep 1, 2017
Results posted
Apr 8, 2021
Last update
Apr 8, 2021

Study contacts

Hirofumi Tanaka, PhD
principal investigator · University of Texas at Austin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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