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Prescribing Laughter for Sleep and Wellbeing in UAE University Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171245
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Zayed University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sleep Mental Health Wellness Other: Laughie laughter prescription Device: Sleep tracking equipment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Can a Laughter Prescription Improve Psychological Health, Wellbeing, and Sleep in Zayed University Students?
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Experimental
One minute laughter prescription 3x a day Tracking sleep using equipment
Other: Laughie laughter prescription
Creation of a Laughie; laughing with their Laughie 3x a day

Device: Sleep tracking equipment
Tracking sleep using equipment

Active Comparator: Control
Tracking sleep using equipment
Device: Sleep tracking equipment
Tracking sleep using equipment




Primary Outcome Measures :
  1. Feasibility of two-week laughter prescription [ Time Frame: 6 months ]
    Using the Laughie. Evaluate with Laughie checklists and interviews


Secondary Outcome Measures :
  1. Assess if subjective sleep outcomes improve [ Time Frame: 6 months ]
    Using PSKI and interviews

  2. Assess if objective sleep outcomes improve [ Time Frame: 6 months ]
    Using wrist actigraphy

  3. Assess if overall well-being improves [ Time Frame: 6 months ]
    Using WHO Five, Laughie checklists, and interviews

  4. Assess if specific aspects of wellbeing improve [ Time Frame: 6 months ]
    Using WHO Five, Laughie checklists, interviews

  5. Assess if mental health improves [ Time Frame: 6 months ]
    Using HADS, interviews



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171245


Contacts
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Contact: Teresa Arora, PhD +971 2 599 3160 Teresa.Arora@zu.ac.ae

Locations
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United Arab Emirates
Zayed University Recruiting
Abu Dhabi, United Arab Emirates, 144534
Contact: Teresa Arora, PhD         
Sponsors and Collaborators
Zayed University
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Responsible Party: Zayed University
ClinicalTrials.gov Identifier: NCT04171245    
Other Study ID Numbers: ZU19_064_F
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zayed University:
Sleep, laughter, well-being, mental health