FibromyalgiaLAFNCT02957110
Laughter Frequency and Fibromyalgia Symptoms
An observational study of Fibromyalgia, run by Walden University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Laughter Frequency
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Oct 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who have been diagnosed with fibromyalgia syndrome.
Who may be able to join
- Individuals who have fibromyalgia syndrome
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationships Between Laughter Frequency, Pain Perception, and Affect in Fibromyalgia Patients
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.
Read the detailed description
Participants will be asked to provide (or authorize the researcher to obtain) fibromyalgia diagnosis confirmation from a health care provider.
Initially, participants will complete a demographics form and two screening assessments. Then for 14 days, they will be asked to rate their momentary mood and overall pain levels three times per day (shortly after waking up, around 3:00 p.m., and at about an hour before bedtime). At the same time, they will be asked to log each instance of laughter as it occurs, daily, for 14 days. They will carry the log with them throughout each day in order to document each instance of laughter.
- Conditions
- Fibromyalgia
- Being tested
- Laughter Frequency
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter FrequencyBehavioural
Relationships between laughter frequency, momentary mood state, and pain will be observed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Laughter Frequency
Documenting each instance of laughter throughout each day.
Measured: 14 days
Pain Ratings
Rating overall pain from 0 to 10, three times daily
Measured: Three times per day for 14 days
Emotional State
Rating momentary emotional state three times per day
Measured: Three times per day for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walden University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deidre Molchan, Walden University
- Investigators
- Ellen Levine, PhD, Study chair, Walden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957110
- Sponsor's protocol ID
- 08-05-16-0146047
- Acronym
- LAF
- Status last verified
- May 2018
- First submitted
- 2 Nov 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationships Between Laughter Frequency, Pain Perception, and Affect in Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT02957110
- Acronym / sponsor ID
- LAF / 08-05-16-0146047
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Walden UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 7 Nov 2016 (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 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.
Detailed description
Participants will be asked to provide (or authorize the researcher to obtain) fibromyalgia diagnosis confirmation from a health care provider.
Initially, participants will complete a demographics form and two screening assessments. Then for 14 days, they will be asked to rate their momentary mood and overall pain levels three times per day (shortly after waking up, around 3:00 p.m., and at about an hour before bedtime). At the same time, they will be asked to log each instance of laughter as it occurs, daily, for 14 days. They will carry the log with them throughout each day in order to document each instance of laughter.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have been diagnosed with fibromyalgia syndrome.
Key inclusion criteria (1 listed)
- Individuals who have fibromyalgia syndrome
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Laughter FrequencyRelationships between laughter frequency, momentary mood state, and pain will be observed. | Behavioural | – |
Primary outcome
Laughter Frequency
Time frame: 14 days
Documenting each instance of laughter throughout each day.
Pain Ratings
Time frame: Three times per day for 14 days
Rating overall pain from 0 to 10, three times daily
Emotional State
Time frame: Three times per day for 14 days
Rating momentary emotional state three times per day
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 7 May 2018.
- 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.
Ellen Levine, PhD study chair
Walden University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Walden 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 7 May 2018. 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?
Laughter Frequency (time frame: 14 days). The study lists 3 primary outcomes in all. 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 7 May 2018.