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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04171245
Other study ID # ZU19_064_F
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 26, 2019
Est. completion date April 15, 2020

Study information

Verified date October 2019
Source Zayed University
Contact Teresa Arora, PhD
Phone +971 2 599 3160
Email Teresa.Arora@zu.ac.ae
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 15, 2020
Est. primary completion date March 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

-

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Laughie laughter prescription
Creation of a Laughie; laughing with their Laughie 3x a day
Device:
Sleep tracking equipment
Tracking sleep using equipment

Locations

Country Name City State
United Arab Emirates Zayed University Abu Dhabi

Sponsors (1)

Lead Sponsor Collaborator
Zayed University

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of two-week laughter prescription Using the Laughie. Evaluate with Laughie checklists and interviews 6 months
Secondary Assess if subjective sleep outcomes improve Using PSKI and interviews 6 months
Secondary Assess if objective sleep outcomes improve Using wrist actigraphy 6 months
Secondary Assess if overall well-being improves Using WHO Five, Laughie checklists, and interviews 6 months
Secondary Assess if specific aspects of wellbeing improve Using WHO Five, Laughie checklists, interviews 6 months
Secondary Assess if mental health improves Using HADS, interviews 6 months
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