Prescribing Laughter for Sleep and Wellbeing in UAE Unive... | NCT04171245

Studies
Prescribing Laughter for Sleep and Wellbeing in UAE University Students

NCT04171245

Sponsor

Zayed University

Status

Unknown status

Last Update Posted

Jan 13, 2020Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Sleep
Mental Health Wellness

Interventions

Laughie laughter prescription
Sleep tracking equipment

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2019Actual

Primary Completion Date

Mar 15, 2020Estimated

Completion Date

Apr 15, 2020Estimated

First Submitted Date

Nov 18, 2019

First Submission Date that Met QC Criteria

Nov 18, 2019

First Posted Date

Nov 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2020

Last Update Posted Date

Jan 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	One minute laughter prescription 3x a day Tracking sleep using equipment	Other: Laughie laughter prescription Device: Sleep tracking equipment
Control	Active Comparator	Tracking sleep using equipment	Device: Sleep tracking equipment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laughie laughter prescription	Other	Creation of a Laughie; laughing with their Laughie 3x a day	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of two-week laughter prescription	Using the Laughie. Evaluate with Laughie checklists and interviews	6 months

Secondary Outcomes

Measure	Description	Time Frame
Assess if subjective sleep outcomes improve	Using PSKI and interviews	6 months
Assess if objective sleep outcomes improve	Using wrist actigraphy

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Teresa Arora, PhD	Contact	+971 2 599 3160		Teresa.Arora@zu.ac.ae

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zayed University	Recruiting	Abu Dhabi		144534	United Arab Emirates

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33305066	Derived	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.

ID	Term
D007845	Laughter
D000092862	Psychological Well-Being

ID	Term
D009633	Nonverbal Communication
D003142	Communication
D001519	Behavior
D010549	Personal Satisfaction