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

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.

The Effect of Listening to Holy Quran Recitation on Weaning Patients Receiving Mechanical Ventilation in the Intensive Care Unit: A Pilot Study.

Mechanical ventilation (MV) causes high level of stress in hospitalized patients. Weaning is the gradual process of decreasing ventilator support that in turn lead to termination of MV and increased respiratory effort, which may exacerbate symptoms and prolong MV. This study aimed to investigate the effect of listening to Holy Quran recitation (HQR) as a non-pharmacological intervention in patients during weaning from mechanical ventilation. This is a randomized controlled trial in which 55 patients admitted in the intensive care unit (ICU) and on mechanical ventilation were recruited. Patients were divided into experimental (case) and control group. In the experimental group, patients received 30 min of HQR, whereas in the control group, patients had 30 min of rest in bed before the start of the weaning. The physiological and/or clinical parameters of weaning were recorded. These parameters include rapid shallow breathing index, respiratory rate, heart rate, oxygen saturation, exhaled carbon dioxide, and blood pressure. The baseline demographic data for groups were presented in tables. The mean age was 54 ± 0.5 years for the experimental and 56.4 ± 18.5 years for the control groups. The physiological and clinical parameters were compared between case and control and found no significant difference. The preliminary findings of this pilot study suggest that there is no negative effect of HQR on weaning patients from mechanical ventilation in the ICU. The results also outline and explorthe possible utility of HQR further in ICU patients as an intervention in weaning patients off from ventilator in the ICU. Although there remains much to be done, our work generates important findings in the field of critical care management.

Moderate hypothermia within 6 h of birth plus inhaled xenon versus moderate hypothermia alone after birth asphyxia (TOBY-Xe): a proof-of-concept, open-label, randomised controlled trial.

BACKGROUND: Moderate cooling after birth asphyxia is associated with substantial reductions in death and disability, but additional therapies might provide further benefit. We assessed whether the addition of xenon gas, a promising novel therapy, after the initiation of hypothermia for birth asphyxia would result in further improvement. METHODS: Total Body hypothermia plus Xenon (TOBY-Xe) was a proof-of-concept, randomised, open-label, parallel-group trial done at four intensive-care neonatal units in the UK. Eligible infants were 36-43 weeks of gestational age, had signs of moderate to severe encephalopathy and moderately or severely abnormal background activity for at least 30 min or seizures as shown by amplitude-integrated EEG (aEEG), and had one of the following: Apgar score of 5 or less 10 min after birth, continued need for resuscitation 10 min after birth, or acidosis within 1 h of birth. Participants were allocated in a 1:1 ratio by use of a secure web-based computer-generated randomisation sequence within 12 h of birth to cooling to a rectal temperature of 33·5°C for 72 h (standard treatment) or to cooling in combination with 30% inhaled xenon for 24 h started immediately after randomisation. The primary outcomes were reduction in lactate to N-acetyl aspartate ratio in the thalamus and in preserved fractional anisotropy in the posterior limb of the internal capsule, measured with magnetic resonance spectroscopy and MRI, respectively, within 15 days of birth. The investigator assessing these outcomes was masked to allocation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00934700, and with ISRCTN, as ISRCTN08886155. FINDINGS: The study was done from Jan 31, 2012, to Sept 30, 2014. We enrolled 92 infants, 46 of whom were randomly assigned to cooling only and 46 to xenon plus cooling. 37 infants in the cooling only group and 41 in the cooling plus xenon group underwent magnetic resonance assessments and were included in the analysis of the primary outcomes. We noted no significant differences in lactate to N-acetyl aspartate ratio in the thalamus (geometric mean ratio 1·09, 95% CI 0·90 to 1·32) or fractional anisotropy (mean difference -0·01, 95% CI -0·03 to 0·02) in the posterior limb of the internal capsule between the two groups. Nine infants died in the cooling group and 11 in the xenon group. Two adverse events were reported in the xenon group: subcutaneous fat necrosis and transient desaturation during the MRI. No serious adverse events were recorded. INTERPRETATION: Administration of xenon within the delayed timeframe used in this trial is feasible and apparently safe, but is unlikely to enhance the neuroprotective effect of cooling after birth asphyxia. FUNDING: UK Medical Research Council.