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NCT Number: NCT07678515

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

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.

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Key information

Conditions

Experimental Aromatherapy Brain Diseases Central Nervous System Diseases Dementia Dry Mouth Feeding Difficulty Mental Disorders Mouth Diseases Nervous System Diseases Neurocognitive Disorders RCT Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yueh-Rong Nursing Home

Tainan, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMART program (Salivary gland massage combined with aromatherapy

Other

The experimental group will receive an intervention comprising salivary gland massage combined with aromatherapy for a total of 20 days.

Primary outcomes

  1. Dementia Feeding Difficulty Cues

    Time frame: Every lunch and dinner from baseline up to 6 weeks

    Feeding difficulty is assessed using the unabbreviated scale title: Dementia Mealtime Nonverbal Cues checklist. This adapted checklist consists of 21 items categorized into negative behaviors (chewing/swallowing difficulty and resistive behaviors; 16 items) and positive/neutral behaviors (5 items). Assuming each item is scored as Yes=1 and No=0, the minimum score is 0 and the maximum is 16 for negative behaviors, where higher scores indicate worse feeding difficulties. For positive behaviors, the score ranges from 0 to 5, where higher scores indicate better feeding performance.

Secondary outcomes

  1. Oral Intake

    Time frame: Every lunch and dinner from baseline up to 6 weeks

    Dietary intake at lunch and dinner will be determined using the plate waste method. Food consumption will be quantitatively assessed by measuring and recording food weights in grams (g) to one decimal place before and after meals using the same electronic weighing scale throughout the study to ensure measurement consistency.

  2. Duration

    Time frame: Every lunch and dinner from baseline up to 6 weeks

    Feeding duration is measured continuously using a timer, from the moment the first bite of food is offered until the meal is completed or terminated. The measurement value is recorded precisely in minutes and seconds (analyzed as total seconds). The minimum value is 0 seconds, with no strict maximum limit. A higher value (longer duration) indicates worse feeding efficiency and greater feeding difficulty.

  3. Oral moisture

    Time frame: Once weekly from baseline up to 6 weeks

    Oral moisture is evaluated using the Mucus® device. The measurement values range from a minimum of 0.0 to a maximum of 99.9. Higher scores indicate better outcomes (normal oral humidity is defined as ≥ 29.6, while ≤ 27.9 indicates dry mouth.

  4. Body weight

    Time frame: Baseline, Week 4 (end of intervention), Week 8 (1 month post-intervention)

    Body weight is measured using a standardized weighing scale, with values recorded in kilograms (kg). To ensure consistency, measurements will be taken at a unified time each month across all participating facilities. The theoretical minimum value is >0 kg, with no strict maximum limit. Because unintentional weight loss is a common complication of feeding difficulties in dementia, weight maintenance or a higher value (weight gain) generally indicates a better nutritional outcome.

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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