- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02896075
Mirthful Laughter and Muscle Soreness / Pain
Social Laughter's Effect on Pain Tolerance
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Austin, Texas, United States, 78712
- Cardiovascular Aging Research Lab at UT Austin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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). |
The intervention is a 30 minute video of a comedy
The intervention is a 30 minute video of an uninteresting documentary
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Force of Pain Tolerance Measurement
Time Frame: 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.
|
This was measured at 24 hours after watching either a comedy or documentary film.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate
Time Frame: This was measured at 24 hours after watching either a comedy or documentary video.
|
The heart rate was using a finger photoplethysmograph.
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This was measured at 24 hours after watching either a comedy or documentary video.
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Blood Pressure
Time Frame: This was measured at 24 hours after watching a comedy or documentary video.
|
Blood pressure on the brachial artery measured via oscillometric methods
|
This was measured at 24 hours after watching a comedy or documentary video.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-05-0092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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