Nurse-led management of sialorrhea in Parkinson's disease: a pilot randomized controlled trial

Abstract

Background – One of the most prevalent non-motor symptoms in people with Parkinson's disease (PD) is sialorrhea. In addition to aggravating pre-existing swallowing and speech issues, sialorrhea frequently causes perioral dermatitis, choking episodes, and aspiration pneumonia. In extreme situations, patients are forced to carry handkerchiefs at all times, which not only damages their reputation and results in social embarrassment and isolation, but also initiates or intensifies psychiatric symptoms like sadness and anxiety. Current management of PD-related sialorrhea includes pharmacological treatments, botulinum toxin, and behavioral strategies. While interventions such as speech therapy and oral exercises are effective, they are often applied episodically in clinical settings. Consequently, patients struggle to sustain these techniques daily. Addressing the lack of integrated nursing protocols for continuous home-based application, this study aimed to develop a structured sialorrhea management program based on the Theory of Symptom Management (SMT) and evaluate its feasibility and preliminary effectiveness. Methods – Based on SMT, an intervention was constructed via expert Delphi consultations. Subsequently, 80 patients with PD-related sialorrhea were randomized into control or intervention groups in a single-center trial. Efficacy was evaluated after four weeks based on sialorrhea severity and self-management capacity. Results – We created an intervention framework with 13 secondary indicators, 39 tertiary indicators, and three primary indicators (symptom experience, symptom management strategies, and symptom management results) after two rounds of Delphi expert consultation. Following the four-week intervention, the intervention group demonstrated significantly lower scores on the Sialorrhea Clinical Scale for PD and the sialorrhea-related item of the Unified PD Rating Scale than the control group (P < 0.05). Furthermore, the intervention group achieved a significantly higher score in self-management ability compared to the control group (P < 0.05). Conclusions – As a structured approach designed to eventually improve quality of life, this sialorrhea intervention program provides preliminary evidence of feasibility and early efficacy in reducing symptom severity and bolstering self-management. Clinical Trial Registration – https://www.chictr.org.cn/index.html, ChiCTR2500096034.