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

NCT07678515 | Enrolling By Invitation

• 1 other identifier: A-ER-114-511
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Experimental; Dementia; RCT; Dry Mouth; Aromatherapy; Feeding Difficulty

Keywords

Dementia; Feeding Difficulty; Dual sensory stimulation

Outcome Measures

Primary Outcomes (1)

• Dementia Feeding Difficulty Cues

  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.

  Every lunch and dinner from baseline up to 6 weeks

Secondary Outcomes (4)

• Oral Intake

  Every lunch and dinner from baseline up to 6 weeks

• Duration

  Every lunch and dinner from baseline up to 6 weeks

• Oral moisture

  Once weekly from baseline up to 6 weeks

• Body weight

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

Study Arms (2)

Control

NO INTERVENTION

Participants in the control group will receive a placebo intervention consisting of a hand massage, accompanied by general greetings and caring interactions, in their daily activity area. This will be conducted before lunch and dinner for four consecutive weeks on weekdays only. To minimize confounding effects, participants will be restricted from exposure to any olfactory or other extraneous sensory stimuli during this 30-minute pre-meal period.

Experimental Group

EXPERIMENTAL

Participants in the experimental group will receive a dual-sensory intervention before lunch and dinner for four consecutive weeks (weekdays only). This consists of a 2-minute salivary gland massage combined with 30 minutes of olfactory stimulation, using 100% lemon essential oil dispersed via a waterless ultrasonic nebulizer.

Other: SMART program (Salivary gland massage combined with aromatherapy

Interventions

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.

Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

Yueh-Rong Nursing Home

Tainan, Taiwan

Location

MeSH Terms

Conditions

Dementia; Xerostomia

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: July 1, 2026
• Study Start: March 16, 2026
• Primary Completion: June 27, 2026
• Study Completion: June 27, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

TW (1)