NCT02957110

Brief Summary

The purpose of this study is to investigate whether daily laughter frequency is associated with pain intensity and emotional state ratings in individuals who have fibromyalgia syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

November 2, 2016

Last Update Submit

May 1, 2018

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (3)

  • Laughter Frequency

    Documenting each instance of laughter throughout each day.

    14 days

  • Pain Ratings

    Rating overall pain from 0 to 10, three times daily

    Three times per day for 14 days

  • Emotional State

    Rating momentary emotional state three times per day

    Three times per day for 14 days

Interventions

Laughter FrequencyBEHAVIORAL

Relationships between laughter frequency, momentary mood state, and pain will be observed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who have been diagnosed with fibromyalgia syndrome.

You may qualify if:

  • Individuals who have fibromyalgia syndrome

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walden University

Minneapolis, Minnesota, 55401, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Ellen Levine, PhD

    Walden University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 7, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

May 7, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)