Effects of a Salivary Gland Massage Program on Salivary Flow , Xerostomia, Chewing, and Swallowing, and Oral Health Among Community- Dwelling Older Adults

Обзор

Purpose: This study aims to evaluate the effectiveness of salivary gland massage on saliva flow, xerostomia, chewing and swallowing, and oral health among community-dwelling elderly. Design: A double-blind, randomized controlled trial, in which both participants and interventionists were unaware of group assignments. Sample and setting: Community-dwelling older adults were recruited from community centers in Minxiong Township and were randomly assigned by center to either the intervention group (n = 54) or the control group (n = 54) using simple randomization. Methods: the investigators conducted a randomized controlled trial with 108 older adults aged 65 and above from community centers in Chiayi County, Taiwan. Participants were randomly assigned to either an intervention group (n=54), who received guided salivary gland massage, or a control group (n=54), who received a health education leaflet on oral care. Before and after the intervention, the investigators assessed dry mouth symptoms, oral mucosal moisture, The Modified Water Swallowing Test, and Tongue Coating Index. Data were analyzed using SPSS version 22, applying chi-square tests, paired t-tests, independent t-tests, and generalized estimating equations to determine whether the massage intervention could improve saliva production, ease dry mouth, enhance chewing and swallowing functions, and promote better oral health. Expected Research Benefits: Salivary gland massage is a simple, safe, and self-administered health promotion method. The findings of this study may serve as an intervention strategy for health promotion programs, aiming to enhance oral health and quality of life among community-dwelling older adults, while reducing the healthcare burden associated with oral health problems. Additionally, this approach may strengthen older adults' engagement in preventive health management and increase their willingness to actively manage their own health.

Вмешательства

• Поведенческое Salivary gland massage
  Participants will perform a salivary gland massage before each of their three meals, 10 times per gland, for three cycles, approximately 2 minutes each, for three months.
• Поведенческое General Oral Health Education
  Health Education Presentation and Leaflet, Massage Not Performed

Первичные конечные точки

• Unstimulated Salivary Flow Rate (mL/min) [Срок оценки: 3 months]

Вторичные конечные точки (4)

• xerostomia [Срок оценки: 3 months]
• Oral mucosal moisture measurement [Срок оценки: 3 months]
• Swallowing assessment [Срок оценки: 3 months]
• Oral health [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Age ≥ 65 years.
• Mentally aware and able to express themselves in Mandarin or Taiwanese.
• Able to follow instructions and participate in activities.
• After the researcher explains the purpose and procedures of the study, they voluntarily participate in the study and sign the informed consent form.

Критерии исключения

• Elderly individuals with Sjögren's disease, head and neck cancer, tongue disease, or those undergoing radiation therapy or chemotherapy.
• Those with cognitive impairment or unable to safely participate in exercise training.
• Those unable to provide written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Тайвань · 1 центр

• Ditmanson Medical Foundation Chiayi Christian Hospital — Chiayi City

Идентификаторы

NCT: NCT07251543 · IRB2025071

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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