PainNCT02896075
Mirthful Laughter and Muscle Soreness / Pain
A study testing 30 Minute Comedy Video and 30 Minute Documentary Video in people with Pain, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- 30 Minute Comedy Video and 30 Minute Documentary Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the age of 20 and 40
- Considered healthy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Aging Research Lab at UT Austin
Austin, Texas, 78712
About this study
Official title: Social Laughter's Effect on Pain Tolerance
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.
- Conditions
- Pain
- Being tested
- 30 Minute Comedy Video, 30 Minute Documentary Video
- Keywords
- delayed onset muscle soreness, laughter
- Medical subject headings
- Pain, Laughter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 Minute Comedy VideoOther
The intervention is a 30 minute video of a comedy
30 Minute Documentary VideoOther
The intervention is a 30 minute video of an uninteresting documentary
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: 30 Minute Comedy Video; Other: 30 Minute Documentary Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This was measured at 24 hours after watching either a comedy or documentary film.
Secondary outcomes (2)
Heart Rate
The heart rate was using a finger photoplethysmograph.
Measured: 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
Measured: This was measured at 24 hours after watching a comedy or documentary video.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start1 Aug 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The main study was conducted using a randomized controlled cross-over approach.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hirofumi Tanaka, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896075
- Sponsor's protocol ID
- 2016-05-0092
- Status last verified
- Apr 2021
- First submitted
- 31 Aug 2016
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Laughter's Effect on Pain Tolerance
- ClinicalTrials.gov ID
- NCT02896075
- Acronym / sponsor ID
- 2016-05-0092
- Conditions
- Pain
- Keywords
- delayed onset muscle soreness, laughter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The main study was conducted using a randomized controlled cross-over approach.
| Arm | Type | Receives |
|---|---|---|
| Randomized cross-over approach | Experimental | Other: 30 Minute Comedy Video, Other: 30 Minute Documentary VideoThe 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). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the age of 20 and 40
- Considered healthy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 Minute Comedy VideoThe intervention is a 30 minute video of a comedy | Other | Randomized cross-over approach |
| 30 Minute Documentary VideoThe intervention is a 30 minute video of an uninteresting documentary | Other | Randomized cross-over approach |
Primary outcome
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.
2 secondary outcomes
Heart Rate
Time frame: This was measured at 24 hours after watching either a comedy or documentary video.
Blood Pressure
Time frame: This was measured at 24 hours after watching a comedy or documentary video.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31733755Lapierre 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hirofumi Tanaka, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 Minute Comedy Video and 30 Minute Documentary Video in people with Pain, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Force of Pain Tolerance Measurement (time frame: This was measured at 24 hours after watching either a comedy or documentary film.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02896075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.