Title

Prescribing laughter to ameliorate mental health, sleep, and wellbeing in university students: A protocol for a feasibility study of a randomised controlled trial

Source of Publication

Contemporary Clinical Trials Communications

Abstract

© 2020 Objectives: This research is the first study to investigate the potential effects of a laughter prescription on both psychological health and objective sleep parameters in university students. The primary objective is to evaluate the feasibility of prescribing laughter to inform a larger randomised controlled trial. Secondary objectives are to assess if a two-week laughter prescription improves subjective and objective sleep outcomes, wellbeing, and/or psychological health outcomes. Trial design: To assess the feasibility of a randomised controlled trial for laughter prescription in relation to sleep, psychological health, and wellbeing. Forty university students will be recruited and randomised to one of two conditions (control/experimental). Methods: Wrist actigraphy and sleep diaries will be used to estimate sleep outcomes during a one-week baseline testing phase and across the two-week intervention. The experimental group will be shown how to record a Laughie (a 1-min recording of their joyful laughter on their smartphone) and prescribed to laugh with it three times daily for 14 days (the control group will only track sleep). All participants will complete the WHO (Five) Well-being Index, and Hospital Anxiety and Depression Scale pre- and post-intervention. The CONSORT checklist, and the Feasibility, Reach-out, Acceptability, Maintenance, Efficacy, Implementation, and Tailorabilty (FRAME-IT) framework will guide intervention planning and evaluation. Participant interviews will be analysed using Differential Qualitative Analysis (DQA). Results: The feasibility of a two-week laughter prescription in university students and its impact on sleep, wellbeing, and/or psychological health outcomes will be assessed. Conclusions: Zayed University Research Ethics Committee approved the study in July 2019. The research will be completed following protocol publication. Trial registration: ClinicalTrials.gov. ID: NCT04171245. Date of registration: 18 October 2019.

Document Type

Article

Publisher

Elsevier BV

Publication Date

12-1-2020

DOI

10.1016/j.conctc.2020.100676

Scopus ID

85097160294

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