Effect of Herbal Medicine (Hwanglyeonhaedok-tang) on Insomnia Patients with Bedtime Procrastination: study protocol for a randomized controlled trial

Abstract

Objectives: Insomnia, characterized by difficulty initiating or maintaining sleep, affects a significant portion of the global population. Bedtime procrastination, which is a voluntary delay in going to bed, is a major contributing factor to the prevalence of sleep deprivation in modern societies. Hwanglyeonhaedok-tang (HJD decoction) has shown promise in improving the symptoms of insomnia. This study aimed to evaluate the efficacy of HJD decoction in patients with insomnia and bedtime procrastination.Methods: This study employs a parallel-group design, comparing HJD decoction to usual care in a 1:1 ratio. Sixty participants with insomnia and bedtime procrastination will be enrolled. The experimental group will receive HJD decoction for 4 weeks, while both groups will undergo a brief behavioral treatment for insomnia. The primary outcome will be the change in the Insomnia Severity Index score (ISI) from baseline to 4 weeks. Secondary outcomes include sleep diary metrics, the Pittsburgh Sleep Quality Index (PSQI), and Bedtime Procrastination Scale (BPS). The exploratory outcomes include perceived stress, anxiety, smartphone use, and heart rate variability.Conclusion: This trial examines the role of herbal medicine in treating a specific type of insomnia that is increasingly common in modern society. The combination of HJD decoction with behavioral intervention offers a comprehensive approach to treating insomnia complicated by bedtime procrastination. The results will provide valuable insights into integrative treatment strategies for sleep disorders in the digital age.

Keywords

• bedtime procrastination
• clinical protocols
• huanglian-jie-du decoction
• hwanglyeonhaedok-tang
• oren gedoku to
• sleep initiation and maintenance disorders