Essential Oil-herbal Sachet Intervention for Sleep Quality and Anxiety in Maintenance Hemodialysis: A Single-center Randomized Trial.

Sleep disturbance and anxiety are common in maintenance hemodialysis patients, yet sustained non-pharmacological management remains difficult in routine dialysis care. This single-center, open-label, parallel-group randomized trial evaluated whether a combined olfactory intervention using an essential-oil preparation and a traditional Chinese herbal sachet was associated with improved self-reported sleep quality and anxiety. Eighty-eight eligible patients with a baseline Pittsburgh Sleep Quality Index (PSQI) score >7 were recruited from Yongkang Hospital of Traditional Chinese Medicine between January 2022 and December 2023 and randomized 1:1 by random-number table to usual care or usual care plus the combined intervention. The trial was not prospectively registered, and participant and intervention-provider blinding was not feasible because of the odor-based intervention. The essential-oil preparation contained lavender essential oil, bergamot essential oil, and coconut oil in a 5:3:10 ratio and was used during dialysis and before sleep; the herbal sachet was placed near the pillow and replaced monthly. Outcomes were assessed using the PSQI and Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) at baseline, day 7, day 15, month 1, and month 3. The primary endpoint was the between-group difference in PSQI global score at month 3. At month 3, the intervention group had lower PSQI scores than the control group (7.8 ± 2.6 vs. 13.8 ± 2.5; adjusted β, -5.37; 95% CI, -6.29 to -4.45; p < 0.001) and lower HADS-A scores (9.2 ± 2.1 vs. 11.8 ± 2.4; adjusted β, -2.61; 95% CI, -3.26 to -1.96; p. < 0.001). Sleep response occurred in 77.3% versus 31.8%, and anxiety response occurred in 68.2% versus 29.5%. Mean adherence was 86.7% for bedtime application and 83.4% for dialysis-session inhalation. Any adverse event was reported in 15.9% versus 6.8%, with no serious intervention-related adverse events. These preliminary findings require confirmation in larger controlled multicenter trials.