Clinical trial NCT04171245: Prescribing Laughter for Sleep and Wellbeing in UAE University Students
Official title: Can a Laughter Prescription Improve Psychological Health, Wellbeing, and Sleep in Zayed University Students?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep
Mental Health Wellness
Keywords: Sleep, laughter, well-being, mental health
Lead sponsor: Zayed University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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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Primary outcomes:
measure: Feasibility of two-week laughter prescription
timeFrame: 6 months
Secondary outcomes:
measure: Assess if subjective sleep outcomes improve
timeFrame: 6 months
measure: Assess if objective sleep outcomes improve
timeFrame: 6 months
measure: Assess if overall well-being improves
timeFrame: 6 months
measure: Assess if specific aspects of wellbeing improve
timeFrame: 6 months
measure: Assess if mental health improves
timeFrame: 6 months
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Zayed University
Study officials:
References:
citation: 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.