BACKGROUNDPhysical restraints are frequently used in ICU patients, while their effects are unclear.OBJECTIVETo explore differences in patient reported mental health outcomes and quality of life between physical restrained and non-physical restrained ICU patients at 3- and 12-months post ICU admission, compared to pre-ICU health status.RESEARCH METHODOLOGY/DESIGNProspective cohort study. Patients were included when 16 years or older, admitted for at least 12 h and provided informed consent. Differences between groups were analysed using linear mixed model analyses.SETTINGTwo ICUs, a 35 bed academic ICU and a 12 bed ICU in a teaching hospital in the Netherlands.MAIN OUTCOME MEASURESSymptoms of anxiety and depression were measured using the Hospital Anxiety and Depression Scale, post-traumatic stress disorder using the Impact of Event Scale-Revised, and Quality of life using the Short Form-36 scores.RESULTS2,764 patients were included, of which 486 (17.6 %) were physically restrained for median 2 [IQR 1-6] days. Significantly worse outcomes were reported at 3-months by physically restrained patients (symptoms of depression 0.89, 95 %CI 0.37 to 1.41, p < 0.001; PCS -2.82, 95 %CI -4.47 to -1,17p < 0.001; MCS -2.67, 95 %CI -4.39 to -0.96, p < 0.01). At 12-months, only the PCS scores remained significantly lower (-1.71, 95 %CI -3.42 to -0.004, p < 0.05).CONCLUSIONUse of physical restraints is associated with worse self-reported symptoms of depression and decreased quality of life 3-months post ICU, and lower physical quality of life after 12-months.IMPLICATIONS FOR CLINICAL PRACTICEUse of physical restraints is associated with statistical significant worse mental and physical outcomes.