- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04171245
Prescribing Laughter for Sleep and Wellbeing in UAE University Students
Can a Laughter Prescription Improve Psychological Health, Wellbeing, and Sleep in Zayed University Students?
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Teresa Arora, PhD
- Telefonnummer: +971 2 599 3160
- E-mail: Teresa.Arora@zu.ac.ae
Studiesteder
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Abu Dhabi, Forenede Arabiske Emirater, 144534
- Rekruttering
- Zayed University
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Kontakt:
- Teresa Arora, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Experimental
One minute laughter prescription 3x a day Tracking sleep using equipment
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Creation of a Laughie; laughing with their Laughie 3x a day
Tracking sleep using equipment
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Aktiv komparator: Control
Tracking sleep using equipment
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Tracking sleep using equipment
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Feasibility of two-week laughter prescription
Tidsramme: 6 months
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Using the Laughie.
Evaluate with Laughie checklists and interviews
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Assess if subjective sleep outcomes improve
Tidsramme: 6 months
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Using PSKI and interviews
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6 months
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Assess if objective sleep outcomes improve
Tidsramme: 6 months
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Using wrist actigraphy
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6 months
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Assess if overall well-being improves
Tidsramme: 6 months
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Using WHO Five, Laughie checklists, and interviews
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6 months
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Assess if specific aspects of wellbeing improve
Tidsramme: 6 months
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Using WHO Five, Laughie checklists, interviews
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6 months
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Assess if mental health improves
Tidsramme: 6 months
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Using HADS, interviews
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6 months
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ZU19_064_F
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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