NCT02896075

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Aug 2016

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

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

August 31, 2016

Results QC Date

September 19, 2019

Last Update Submit

April 5, 2021

Conditions

Keywords

delayed onset muscle sorenesslaughter

Outcome Measures

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.

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

Secondary Outcomes (2)

  • Heart Rate

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

  • Blood Pressure

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

Study Arms (1)

Randomized cross-over approach

EXPERIMENTAL

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 VideoOther: 30 Minute Documentary Video

Interventions

The intervention is a 30 minute video of a comedy

Randomized cross-over approach

The intervention is a 30 minute video of an uninteresting documentary

Randomized cross-over approach

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the age of 20 and 40
  • Considered healthy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Aging Research Lab at UT Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

PainLaughter

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNonverbal CommunicationCommunicationBehavior

Results Point of Contact

Title
Stephanie Lapierre
Organization
University of Texas at Austin

Study Officials

  • Hirofumi Tanaka, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The main study was conducted using a randomized controlled cross-over approach.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 12, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

April 8, 2021

Results First Posted

April 8, 2021

Record last verified: 2021-04

Locations