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
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.
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.
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This study's enrollment of 40 is close to the median of 44 across 241 interventional studies indexed under Myalgia.
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Exclusion Criteria:
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
The intervention is a 30 minute video of a comedy
The intervention is a 30 minute video of an uninteresting documentary
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.
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.
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.
Participants were recruited from the University student body and the city surrounding the university using flyers
| Milestone | All Study Participants Acting Their Own Controls |
|---|---|
| Started | 40 |
| Leg soreness | 40 |
| Completed | 40 |
| Not completed | 0 |
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.
| N | Comedy Video | Documentary Watching |
|---|---|---|
| Peak Force of Pain Tolerance Measurement | 2 ± 3 | 21 ± 5 |
The heart rate was using a finger photoplethysmograph.
| beats/minutres | Comedy Watching | Documentary Watching |
|---|---|---|
| Heart Rate | 67 ± 12 | 66 ± 13 |
Blood pressure on the brachial artery measured via oscillometric methods
| mmHg | Comedy Watching | Documentary Watching |
|---|---|---|
| Systolic blood pressure | 116 ± 10 | 116 ± 10 |
| Diastolic blood pressure | 57 ± 7 | 57 ± 7 |
Collected over ~9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Leg With and Without Delayed Onset Muscle Soreness | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 40 |
| >=65 years | 0 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 23 ± 4 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 25 |
| Male | 15 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 10 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 27 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 40 |
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University of Texas at Austin