Salivary Gland Massage and Olfactory Stimulation for Relieving Feeding Difficulty and Triggering Oral Intake Among People With Dementia
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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Tainan, Tajwan
- Yueh-Rong Nursing Home
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: 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.
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Eksperymentalny: 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.
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The experimental group will receive an intervention comprising salivary gland massage combined with aromatherapy for a total of 20 days.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Dementia Feeding Difficulty Cues
Ramy czasowe: Every lunch and dinner from baseline up to 6 weeks
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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.
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Every lunch and dinner from baseline up to 6 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Oral Intake
Ramy czasowe: Every lunch and dinner from baseline up to 6 weeks
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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.
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Every lunch and dinner from baseline up to 6 weeks
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Duration
Ramy czasowe: Every lunch and dinner from baseline up to 6 weeks
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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.
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Every lunch and dinner from baseline up to 6 weeks
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Oral moisture
Ramy czasowe: Once weekly from baseline up to 6 weeks
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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.
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Once weekly from baseline up to 6 weeks
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Body weight
Ramy czasowe: Baseline, Week 4 (end of intervention), Week 8 (1 month post-intervention)
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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.
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Baseline, Week 4 (end of intervention), Week 8 (1 month post-intervention)
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby jamy ustnej
- Choroby Stomatognatyczne
- Choroby mózgu
- Choroby ośrodkowego układu nerwowego
- Choroby Układu Nerwowego
- Zaburzenia psychiczne
- Zaburzenia neurokognitywne
- Choroby gruczołów ślinowych
- Demencja
- Kserostomia
- Lecznictwo
- Terapie umysłowe
- Terapie uzupełniające
- Psychoterapia
- Dyscypliny i działania behawioralne
- Terapie sztuki sensoryczne
- Fitoterapia
- Aromaterapia
Inne numery identyfikacyjne badania
- A-ER-114-511
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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