Mirthful Laughter and Muscle Soreness / Pain

Sponsor
University of Texas at Austin (Other)
Overall Status
Completed
CT.gov ID
NCT02896075
Collaborator
(none)
40
1
1
13
3.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: 30 Minute Comedy Video
  • Other: 30 Minute Documentary Video
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The main study was conducted using a randomized controlled cross-over approach.The main study was conducted using a randomized controlled cross-over approach.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Social Laughter's Effect on Pain Tolerance
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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
The intervention is a 30 minute video of a comedy

Other: 30 Minute Documentary Video
The intervention is a 30 minute video of an uninteresting documentary

Outcome Measures

Primary Outcome Measures

  1. Peak Force of Pain Tolerance Measurement [This was measured at 24 hours after watching either a comedy or documentary film.]

    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.

Secondary Outcome Measures

  1. Heart Rate [This was measured at 24 hours after watching either a comedy or documentary video.]

    The heart rate was using a finger photoplethysmograph.

  2. Blood Pressure [This was measured at 24 hours after watching a comedy or documentary video.]

    Blood pressure on the brachial artery measured via oscillometric methods

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Between the age of 20 and 40

  • Considered healthy

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cardiovascular Aging Research Lab at UT Austin Austin Texas United States 78712

Sponsors and Collaborators

  • University of Texas at Austin

Investigators

  • Principal Investigator: Hirofumi Tanaka, PhD, University of Texas at Austin

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT02896075
Other Study ID Numbers:
  • 2016-05-0092
First Posted:
Sep 12, 2016
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by University of Texas at Austin
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Participants were recruited from the University student body and the city surrounding the university using flyers
Pre-assignment Detail 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).
Arm/Group Title All Study Participants Acting Their Own Controls
Arm/Group Description 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).
Period Title: Overall Study
STARTED 40
Leg Soreness 40
COMPLETED 40
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title All Study Participants
Arm/Group Description young healthy people with delayed onset muscle soreness in either the right or left leg will go through the 30 Minute Comedy Video and the 30 Minute Documentary Video. 30 Minute Comedy Video: The intervention is a 30 minute video of a comedy 30 Minute Documentary Video: The intervention is a 30 minute video of an uninteresting documentary
Overall Participants 40
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
40
100%
>=65 years
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
23
(4)
Sex: Female, Male (Count of Participants)
Female
25
62.5%
Male
15
37.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
10
25%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
2
5%
White
27
67.5%
More than one race
0
0%
Unknown or Not Reported
1
2.5%
Region of Enrollment (participants) [Number]
United States
40
100%

Outcome Measures

1. Primary Outcome
Title Peak Force of Pain Tolerance Measurement
Description 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.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Comedy Video Documentary Watching
Arm/Group Description The intervention is watching a 30 minute video of a comedy The intervention is watching a 30 minute video of a documentary
Measure Participants 40 40
Mean (Standard Deviation) [N]
2
(3)
21
(5)
2. Secondary Outcome
Title Heart Rate
Description The heart rate was using a finger photoplethysmograph.
Time Frame This was measured at 24 hours after watching either a comedy or documentary video.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Comedy Watching Documentary Watching
Arm/Group Description The intervention is watching a 30 minute video of a comedy The intervention is watching a 30 minute video of a documentary.
Measure Participants 40 40
Mean (Standard Error) [beats/minutres]
67
(12)
66
(13)
3. Secondary Outcome
Title Blood Pressure
Description 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.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Comedy Watching Documentary Watching
Arm/Group Description The intervention is watching a 30 minute video of a comedy The intervention is watching a 30 minute video of a documentary.
Measure Participants 40 40
Systolic blood pressure
116
(10)
116
(10)
Diastolic blood pressure
57
(7)
57
(7)

Adverse Events

Time Frame ~9 months
Adverse Event Reporting Description This is a behavioral observational study that participants were asked to watch videos in the laboratory. No adverse event would be expected.
Arm/Group Title Leg With and Without Delayed Onset Muscle Soreness
Arm/Group Description young healthy people with delayed onset muscle soreness in either the right or left leg will go through the 30 Minute Comedy Video and the 30 Minute Documentary Video. 30 Minute Comedy Video: The intervention is a 30 minute video of a comedy 30 Minute Documentary Video: The intervention is a 30 minute video of an uninteresting documentary
All Cause Mortality
Leg With and Without Delayed Onset Muscle Soreness
Affected / at Risk (%) # Events
Total 0/20 (0%)
Serious Adverse Events
Leg With and Without Delayed Onset Muscle Soreness
Affected / at Risk (%) # Events
Total 0/20 (0%)
Other (Not Including Serious) Adverse Events
Leg With and Without Delayed Onset Muscle Soreness
Affected / at Risk (%) # Events
Total 0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Stephanie Lapierre
Organization University of Texas at Austin
Phone 512-471-8594
Email stephlap1116@gmail.com
Responsible Party:
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT02896075
Other Study ID Numbers:
  • 2016-05-0092
First Posted:
Sep 12, 2016
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021