Key result
Phototherapy and sleep hygiene fail to significantly improve sleep quality in heart failure.
Why the study?
Do non-pharmacological interventions improve quality of sleep and quality of life in patients with heart failure?
RCT (n=32)
Single-blind (evaluator blinded)
Computer-generated (blocks)
No
Do non-pharmacological interventions improve quality of sleep and quality of life in patients with heart failure?
A pilot RCT of non-pharmacological interventions for sleep and quality of life in heart failure patients found no significant differences between groups but provided effect sizes for future confirmatory trials.
Pilot RCT shows no significant group differences, precluding practice change in heart failure; effect sizes guide sample sizing for definitive trials.
OBJECTIVE: to estimate the effects of non-pharmacological interventions to improve the quality of sleep and quality of life of patients with heart failure. METHOD: pilot study of a randomized controlled trial with 32 individuals assigned to four groups. Sleep was assessed using the Pittsburgh Sleep Quality Inventory, while health-related quality of life was assessed using the Minnesota Living with Heart Failure Questionnaire, at the baseline and at the 12th and 24th weeks. The means of the outcomes according to intervention groups were compared using analysis of covariance; effect sizes were calculated per group. RESULTS: all groups experienced improved quality of sleep and health-related quality of life at the end of the intervention (week 12) and at follow-up (week 24), though differences were not statistically significant (p between 0.22 and 0.40). The effects of the interventions at the 12th week ranged between -2.1 and -3.8 for the quality of sleep and between -0.8 and -1.7 for quality of life, with similar values at the 24th week. CONCLUSION: the effects found in this study provide information for sample size calculations and statistical power for confirmatory studies. Brazilian Clinical Trials Registry - RBR 7jd2mm.
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Santos et al. (2018) conducted an RCT in Heart Failure (n=32). Phototherapy and/or Sleep hygiene measures vs. Control (general disease guidance) was evaluated on Quality of sleep (PSQI score) at 12 weeks (p=0.22). Phototherapy and sleep hygiene interventions improved sleep quality and quality of life in patients with heart failure, though differences between the intervention and control groups were not statistically significant.
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