- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171245
Prescribing Laughter for Sleep and Wellbeing in UAE University Students
Can a Laughter Prescription Improve Psychological Health, Wellbeing, and Sleep in Zayed University Students?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Teresa Arora, PhD
- Phone Number: +971 2 599 3160
- Email: Teresa.Arora@zu.ac.ae
Study Locations
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-
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Abu Dhabi, United Arab Emirates, 144534
- Recruiting
- Zayed University
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Contact:
- Teresa Arora, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
One minute laughter prescription 3x a day Tracking sleep using equipment
|
Creation of a Laughie; laughing with their Laughie 3x a day
Tracking sleep using equipment
|
Active Comparator: Control
Tracking sleep using equipment
|
Tracking sleep using equipment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of two-week laughter prescription
Time Frame: 6 months
|
Using the Laughie.
Evaluate with Laughie checklists and interviews
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess if subjective sleep outcomes improve
Time Frame: 6 months
|
Using PSKI and interviews
|
6 months
|
Assess if objective sleep outcomes improve
Time Frame: 6 months
|
Using wrist actigraphy
|
6 months
|
Assess if overall well-being improves
Time Frame: 6 months
|
Using WHO Five, Laughie checklists, and interviews
|
6 months
|
Assess if specific aspects of wellbeing improve
Time Frame: 6 months
|
Using WHO Five, Laughie checklists, interviews
|
6 months
|
Assess if mental health improves
Time Frame: 6 months
|
Using HADS, interviews
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ZU19_064_F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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