Salivary Gland Massage and Olfactory Stimulation for Relieving Feeding Difficulty and Triggering Oral Intake Among People With Dementia

Official title

SMART-program：Dual Sensory-Stimulation for Relieving Feeding Difficulty and Triggering Oral Intake Among People With Dementia

Overview

Feeding difficulties are a common issue among individuals with dementia during moderate to advanced stages, particularly those in long-term care (LTC) facilities. Due to severe cognitive and communicative impairment, these residents often have a high dependency on feeding assistance. Consequently, caregivers manage not only refusal to eat and prolonged mealtimes but also the resulting nutritional problems among these patients. The eating process includes the anticipatory phase, during which food is identified via sensory triggers, thereby stimulating saliva secretion. This process facilitates bolus formation and ensures a smooth transition to the swallowing phase. Accordingly, this study aims to investigate the efficacy of a dual-sensory intervention, combining salivary gland massage and olfactory stimulation, in improving feeding difficulties and food intake among individuals with moderate-to-severe dementia. This study will employ a randomized controlled trial (RCT) design. The experimental group will receive an intervention comprising salivary gland massage combined with aromatherapy for a total of 20 days. Simultaneously, baseline characteristics, including sociodemographic data, health status, and oral moisture, will be collected. Data for the 'Dementia Mealtime Nonverbal Cues' and two-meal intake will be monitored daily on weekdays for two weeks; all other variables will be assessed once. During the intervention period, the experimental procedure will be performed twice daily, prior to lunch and dinner. The control group will receive only a palm massage prior to meals. Throughout the intervention, participants will be assessed for "The Dementia Mealtime Nonverbal Cues" and oral intake during lunch and dinner every weekday. Additionally, oral moisture will be evaluated once weekly (T1-T4). Data will be analyzed using Linear Mixed Models (LMM) to examine the differences and longitudinal changes in outcome measures between the two groups. The findings of this study will contribute to the establishment of a safe, feasible, and culturally appropriate feeding care model for institutionalized individuals with dementia.

Interventions

• Other SMART program (Salivary gland massage combined with aromatherapy
  The experimental group will receive an intervention comprising salivary gland massage combined with aromatherapy for a total of 20 days.

Primary outcome measures

• Dementia Feeding Difficulty Cues [Time frame: Every lunch and dinner from baseline up to 6 weeks]

Secondary outcome measures (4)

• Oral Intake [Time frame: Every lunch and dinner from baseline up to 6 weeks]
• Duration [Time frame: Every lunch and dinner from baseline up to 6 weeks]
• Oral moisture [Time frame: Once weekly from baseline up to 6 weeks]
• Body weight [Time frame: Baseline, Week 4 (end of intervention), Week 8 (1 month post-intervention)]

Eligibility criteria

Inclusion criteria

• Resided in a long-term care (LTC) facility for more than three months.
• Diagnosed with any type of dementia, with either a Clinical Dementia Rating (CDR) of 2 or higher, a Mini-Mental State Examination (MMSE) score below 20, or a Short Portable Mental Status Questionnaire (SPMSQ) score greater than or equal to 3 errors (indicating moderate to severe impairment).
• A feeding item score of below 5 on the Barthel Index (indicating the participant needs assistance with cutting food, spreading butter, etc., or requires a modified diet or is unable to feed themselves). DOCX

Exclusion criteria

• Absence of observable expression, behavioral, or response to olfactory stimuli.
• Current use of a nasogastric tube (NG tube) or a percutaneous endoscopic gastrostomy (PEG).
• Diagnosis of hyperphagia or pica.
• Inability to cooperate with the required salivary gland massage.
• Uncontrolled epilepsy, severe or unstable cardiovascular disease, severe asthma, severe chronic obstructive pulmonary disease (COPD), or gastrointestinal bleeding.
• Known allergy to essential oils.
• Undergone surgery related to oral, tongue, or thyroid cancer.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Taiwan · 1 center

• Yueh-Rong Nursing Home — Tainan

Identifiers

NCT: NCT07678515 · A-ER-114-511

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗