NCT04171245

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

January 13, 2020

Status Verified

October 1, 2019

Enrollment Period

6 months

First QC Date

November 18, 2019

Last Update Submit

January 9, 2020

Conditions

Keywords

Sleep, laughter, well-being, mental health

Outcome Measures

Primary Outcomes (1)

  • Feasibility of two-week laughter prescription

    Using the Laughie. Evaluate with Laughie checklists and interviews

    6 months

Secondary Outcomes (5)

  • Assess if subjective sleep outcomes improve

    6 months

  • Assess if objective sleep outcomes improve

    6 months

  • Assess if overall well-being improves

    6 months

  • Assess if specific aspects of wellbeing improve

    6 months

  • Assess if mental health improves

    6 months

Study Arms (2)

Experimental

EXPERIMENTAL

One minute laughter prescription 3x a day Tracking sleep using equipment

Other: Laughie laughter prescriptionDevice: Sleep tracking equipment

Control

ACTIVE COMPARATOR

Tracking sleep using equipment

Device: Sleep tracking equipment

Interventions

Creation of a Laughie; laughing with their Laughie 3x a day

Experimental

Tracking sleep using equipment

ControlExperimental

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zayed University

Abu Dhabi, 144534, United Arab Emirates

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

LaughterPsychological Well-Being

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehaviorPersonal Satisfaction

Central Study Contacts

Teresa Arora, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 20, 2019

Study Start

September 26, 2019

Primary Completion

March 15, 2020

Study Completion

April 15, 2020

Last Updated

January 13, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations