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

28 juni 2026 uppdaterad av: Shu-Ying Li, National Cheng Kung University

SMART-program：Dual Sensory-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.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Taiwan
      • Tainan, Taiwan
        • Yueh-Rong Nursing Home

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  1. Resided in a long-term care (LTC) facility for more than three months.
  2. 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).
  3. 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:

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Control
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.
Experimentell: Experimental Group
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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dementia Feeding Difficulty Cues
Tidsram: 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.
Every lunch and dinner from baseline up to 6 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Oral Intake
Tidsram: 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.
Every lunch and dinner from baseline up to 6 weeks
Duration
Tidsram: 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.
Every lunch and dinner from baseline up to 6 weeks
Oral moisture
Tidsram: 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.
Once weekly from baseline up to 6 weeks
Body weight
Tidsram: 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.
Baseline, Week 4 (end of intervention), Week 8 (1 month post-intervention)

Samarbetspartners och utredare

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Sponsor

National Cheng Kung University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 mars 2026

Primärt slutförande (Beräknad)

27 juni 2026

Avslutad studie (Beräknad)

27 juni 2026

Studieregistreringsdatum

Först inskickad

2 juni 2026

Först inskickad som uppfyllde QC-kriterierna

28 juni 2026

Första postat (Faktisk)

1 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • A-ER-114-511

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