SleepNCT04171245
Prescribing Laughter for Sleep and Wellbeing in UAE University Students
A study testing Laughie laughter prescription and Sleep tracking equipment in people with Sleep and Mental Health Wellness, run by Zayed University at 1 site in United Arab Emirates.
Trial summary
This study is in line with the UAEs national drive to promote happiness and wellbeing. University students risk impaired psychological health, wellbeing, and sleep due to academic pressures. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep, Mental Health Wellness
- What is being tested?
- Laughie laughter prescription and Sleep tracking equipment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 26 Sep 2019to 15 Apr 2020
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: Registered Zayed University students, owner of a smartphone -
Exclusion Criteria: Chronic health conditions (cardiovascular disease, respiratory disease, cancer, diabetes), deafness, non-English speakers
-
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Zayed University
Abu Dhabi, 144534
Teresa Arora, PhD
About this study
Official title: Can a Laughter Prescription Improve Psychological Health, Wellbeing, and Sleep in Zayed University Students?
This study is in line with the UAEs national drive to promote happiness and wellbeing. University students risk impaired psychological health, wellbeing, and sleep due to academic pressures. This research is the first to assess the feasibility of using a laughter prescription to improve psychological health and sleep in Zayed University students. Forty students will be recruited, and randomized to a control or laughter group.
Read the detailed description
The Laughie is a self created app or tool. It is a one minute recording of the user's joyful laughter on their smartphone. Once recorded, the user uses it by playing back the recording and laughing with it for the duration of the one minute. The Laughie acts as a prompt to guide the one minute of laughter.
In this research the experimental group each record their own Laughie, demonstrated and supported by the PI(s). They are then prescribed to laugh with their Laughie: 3x a day the first week (morning, lunch, and afternoon) and at least 2x a day during the second week. Immediately after using their Laughie they fill in a Laughie checklist to record whether they laughed for the full minute, whether they enjoyed their Laughie, and how they felt afterwards.
This study tracks sleep using wrist actigraphy in the control group (no Laughie prescription) and in the Laughie group. All participants complete one week baseline using sleep watches, and sleep diaries, prior to the Laughie intervention. They all then continue to track their sleep during the intervention. All participants complete WHO Five well-being, PSKI, and HADS pre and post intervention. During the intervention the Laughie participants complete Laughie checklists. All participants are invited for a final interview (the control group about the sleep equipment experience). A follow-up survey is sent to the Laughie group 2 months after their prescription.
- Conditions
- Sleep, Mental Health Wellness
- Being tested
- Laughie laughter prescription, Sleep tracking equipment
- Keywords
- Sleep, laughter, well-being, mental health
- Medical subject headings
- Laughter, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughie laughter prescriptionOther
Creation of a Laughie; laughing with their Laughie 3x a day
Sleep tracking equipmentDevice
Tracking sleep using equipment
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | One minute laughter prescription 3x a day Tracking sleep using equipment Receives: Other: Laughie laughter prescription; Device: Sleep tracking equipment |
| Control | Active comparator | Tracking sleep using equipment Receives: Device: Sleep tracking equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of two-week laughter prescription
Using the Laughie. Evaluate with Laughie checklists and interviews
Measured: 6 months
Secondary outcomes (5)
Assess if subjective sleep outcomes improve
Using PSKI and interviews
Measured: 6 months
Assess if objective sleep outcomes improve
Using wrist actigraphy
Measured: 6 months
Assess if overall well-being improves
Using WHO Five, Laughie checklists, and interviews
Measured: 6 months
Assess if specific aspects of wellbeing improve
Using WHO Five, Laughie checklists, interviews
Measured: 6 months
Assess if mental health improves
Using HADS, interviews
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start26 Sep 2019
- Primary completion15 Mar 2020 (estimated)
- Study completion15 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zayed University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171245
- Sponsor's protocol ID
- ZU19_064_F
- Status last verified
- Oct 2019
- First submitted
- 18 Nov 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonot-Schoupinsky FN, Garip G, Sheffield D, Omar OM, Arora T. Prescribing laughter to ameliorate mental health, sleep, and wellbeing in university students: A protocol for a feasibility study of a randomised controlled trial. Contemp Clin Trials Commun. 2020 Nov 26;20:100676. doi: 10.1016/j.conctc.2020.100676. eCollection 2020 Dec.
PubMed 33305066
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Laughter Prescription Improve Psychological Health, Wellbeing, and Sleep in Zayed University Students?
- ClinicalTrials.gov ID
- NCT04171245
- Acronym / sponsor ID
- ZU19_064_F
- Conditions
- Sleep, Mental Health Wellness
- Keywords
- Sleep, laughter, well-being, mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zayed UniversityUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 Apr 2020 (estimated)
- First posted
- 20 Nov 2019 (actual)
- 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.
This study is in line with the UAEs national drive to promote happiness and wellbeing. University students risk impaired psychological health, wellbeing, and sleep due to academic pressures. This research is the first to assess the feasibility of using a laughter prescription to improve psychological health and sleep in Zayed University students. Forty students will be recruited, and randomized to a control or laughter group.
Detailed description
The Laughie is a self created app or tool. It is a one minute recording of the user's joyful laughter on their smartphone. Once recorded, the user uses it by playing back the recording and laughing with it for the duration of the one minute. The Laughie acts as a prompt to guide the one minute of laughter.
In this research the experimental group each record their own Laughie, demonstrated and supported by the PI(s). They are then prescribed to laugh with their Laughie: 3x a day the first week (morning, lunch, and afternoon) and at least 2x a day during the second week. Immediately after using their Laughie they fill in a Laughie checklist to record whether they laughed for the full minute, whether they enjoyed their Laughie, and how they felt afterwards.
This study tracks sleep using wrist actigraphy in the control group (no Laughie prescription) and in the Laughie group. All participants complete one week baseline using sleep watches, and sleep diaries, prior to the Laughie intervention. They all then continue to track their sleep during the intervention. All participants complete WHO Five well-being, PSKI, and HADS pre and post intervention. During the intervention the Laughie participants complete Laughie checklists. All participants are invited for a final interview (the control group about the sleep equipment experience). A follow-up survey is sent to the Laughie group 2 months after their prescription.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Laughie laughter prescription, Device: Sleep tracking equipmentOne minute laughter prescription 3x a day Tracking sleep using equipment |
| Control | Active comparator | Device: Sleep tracking equipmentTracking sleep using equipment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Laughie laughter prescriptionCreation of a Laughie; laughing with their Laughie 3x a day | Other | Experimental |
| Sleep tracking equipmentTracking sleep using equipment | Device | Control, Experimental |
Primary outcome
Feasibility of two-week laughter prescription
Time frame: 6 months
Using the Laughie. Evaluate with Laughie checklists and interviews
5 secondary outcomes
Assess if subjective sleep outcomes improve
Time frame: 6 months
Assess if objective sleep outcomes improve
Time frame: 6 months
Assess if overall well-being improves
Time frame: 6 months
Assess if specific aspects of wellbeing improve
Time frame: 6 months
Assess if mental health improves
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 33305066Gonot-Schoupinsky FN, Garip G, Sheffield D, Omar OM, Arora T. Prescribing laughter to ameliorate mental health, sleep, and wellbeing in university students: A protocol for a feasibility study of a randomised controlled trial. Contemp Clin Trials Commun. 2020 Nov 26;20:100676. doi: 10.1016/j.conctc.2020.100676. eCollection 2020 Dec.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughie laughter prescription and Sleep tracking equipment in people with Sleep and Mental Health Wellness, run by Zayed University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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 Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Arora, PhD (+971 2 599 3160, Teresa.Arora@zu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of two-week laughter prescription (time frame: 6 months). 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 NCT04171245, 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 13 Jan 2020.