"The Effect of Humor and Laughter on C Reactive Protein:... | NCT02415231

Studies
"The Effect of Humor and Laughter on C Reactive Protein: A Pilot Study"

NCT02415231

Sponsor

Loma Linda University

Status

Completed

Last Update Posted

Mar 17, 2017Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

humor

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Apr 9, 2015

First Submission Date that Met QC Criteria

Apr 13, 2015

First Posted Date

Apr 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2017

Last Update Posted Date

Mar 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

5. "Subjects will be between ___18_ and ___99_ years of age."

6. "In total, subject participation will last approximately ___1 day for 90 minutes_

7. "Subjects will be recruited _by word of mouth at the Loma Linda University Campus and surrounding communities___."

8. "Consent will take place _by investigators in Nichol Hall Room A620/A640___."

9. If Multi-center:

10. If Single center or investigator-initiated:

"_60__ subjects will participate in the study."

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
humor	Experimental	humor group will watch humor video for 20 minutes	Behavioral: humor
control non humor	No Intervention	control group did not watch humor, they sat quietly for 20 minutes.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
humor	Behavioral		humor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CRP level		change in CRP levels over 3 time frames (baseine, immediately after intervention, and 30 minutes later)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 18-99 yrs , healthy individuals

Exclusion Criteria:

Under 18 years old, or over 99 years old, non healthy individuals

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
gurinder bains, MD PhD	Loma Linda University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nichol Hall Room A640		Loma Linda	California	92350	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020327	Glaucoma Drainage Implants

Ancestor Terms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided