Key result
PUME trial investigates acute effects of induced negative emotions on endothelial function in healthy adults.
Why the study?
Do induced negative emotions (anger, anxiety, sadness) impair endothelial function compared to a neutral condition in healthy participants?
RCT (n=280)
Single-blind
Block randomization
No
Do induced negative emotions (anger, anxiety, sadness) impair endothelial function compared to a neutral condition in healthy participants?
This study protocol outlines a randomized controlled experiment to investigate the impact of induced negative emotions on endothelial function in healthy participants.
Does not yet alter clinical management of emotional triggers; leaves open whether induced negative emotions impair endothelial function.
INTRODUCTION: The experience of negative emotions (eg, anger, anxiety and sadness) is associated with an increased short-term risk of incident cardiovascular disease (CVD) events, independent of traditional CVD risk factors. Impairment in endothelial function is one possible biological mechanism which may explain the association between negative emotions and incident CVD events. This laboratory-based, single-blind, randomised controlled experimental study aims to investigate the impact of induced negative emotions including anger, anxiety and sadness on endothelial function. METHODS AND ANALYSIS: In a between-subjects design, 280 healthy participants are randomised to one of four experimental negative emotion inductions: anger, anxiety, sadness or a neutral condition. Endothelium-dependent vasodilation, circulating levels of endothelial cell-derived microparticles and bone marrow-derived endothelial progenitor cells, and indices of nitric oxide inhibition are assessed before and 3, 40, 70 and 100 min after negative emotion induction. Finally, in a subsample of 84 participants, the potential moderating effects of cardiorespiratory fitness and habitual physical activity on the adverse effects of an acute negative emotion on endothelial function are investigated. ETHICS AND DISSEMINATION: This study is conducted in compliance with the Helsinki Declaration and the Columbia University Medical Center Institutional Review Board. The results of the study will be disseminated at several research conferences and as published articles in peer reviewed journals. The study will be implemented and reported in line with the SPIRIT statement. TRIAL REGISTRATION NUMBER: NCT01909895; Pre-results.
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Ensari et al. (2018) conducted an RCT in Healthy participants (n=280). Negative emotion induction (anger, anxiety, or sadness) vs. Neutral condition (counting aloud) was evaluated on Endothelium-dependent vasodilation (RHI), circulating endothelial cell-derived microparticles (CD62E+ EMPs), and endothelial progenitor cells (CD34+/CD133+/KDR+).
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