HealthyNCT02415231
"The Effect of Humor and Laughter on C Reactive Protein: A Pilot Study"
A study testing humor in people with Healthy, run by Loma Linda University at 1 site in United States.
Trial summary
The study is to see if watching humor and laughing can affect CRP levels in healthy individuals. This is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- humor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-99 yrs , healthy individuals
Who cannot join
- Under 18 years old, or over 99 years old, non healthy individuals
Trial locations and contacts
1 site in 1 country.
About this study
The study is to see if watching humor and laughing can affect CRP levels in healthy individuals. This is a randomized controlled trial.
Read the detailed description
Subjects will be…males and females: students, employees, and members of the community.
- "Subjects will be between ___18_ and ___99_ years of age."
- "In total, subject participation will last approximately ___1 day for 90 minutes_
- "Subjects will be recruited _by word of mouth at the Loma Linda University Campus and surrounding communities___."
- "Consent will take place _by investigators in Nichol Hall Room A620/A640___."
- If Multi-center:
- If Single center or investigator-initiated:
"_60__ subjects will participate in the study."
- Conditions
- Healthy
- Being tested
- humor
- Keywords
- humor laughter C reactive protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
humorBehavioural
| Study group | Role | What they receive |
|---|---|---|
| humor | Experimental | humor group will watch humor video for 20 minutes Receives: Behavioral: humor |
| control non humor | No intervention | control group did not watch humor, they sat quietly for 20 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP level
Measured: change in CRP levels over 3 time frames (baseine, immediately after intervention, and 30 minutes later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurinder Bains, Loma Linda University
- Investigators
- gurinder bains, MD PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415231
- Sponsor's protocol ID
- 5150100
- Status last verified
- Mar 2017
- First submitted
- 9 Apr 2015
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Humor and Laughter on C Reactive Protein: A Pilot Study"
- ClinicalTrials.gov ID
- NCT02415231
- Acronym / sponsor ID
- 5150100
- Conditions
- Healthy
- Keywords
- humor laughter C reactive protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is to see if watching humor and laughing can affect CRP levels in healthy individuals. This is a randomized controlled trial.
Detailed description
Subjects will be…males and females: students, employees, and members of the community.
- "Subjects will be between ___18_ and ___99_ years of age."
- "In total, subject participation will last approximately ___1 day for 90 minutes_
- "Subjects will be recruited _by word of mouth at the Loma Linda University Campus and surrounding communities___."
- "Consent will take place _by investigators in Nichol Hall Room A620/A640___."
- If Multi-center:
- If Single center or investigator-initiated:
"_60__ subjects will participate in the study."
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| humor | Experimental | Behavioral: humorhumor group will watch humor video for 20 minutes |
| control non humor | No intervention | –control group did not watch humor, they sat quietly for 20 minutes. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ages 18-99 yrs , healthy individuals
Key exclusion criteria (1 listed)
- Under 18 years old, or over 99 years old, non healthy individuals
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 |
|---|---|---|
| humor | Behavioural | humor |
Primary outcome
CRP level
Time frame: change in CRP levels over 3 time frames (baseine, immediately after intervention, and 30 minutes later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Individual participant dataSharing planned: No
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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.
gurinder bains, MD PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing humor in people with Healthy, run by Loma Linda University 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 1 inclusion and 1 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 17 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CRP level (time frame: change in CRP levels over 3 time frames (baseine, immediately after intervention, and 30 minutes later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2017.