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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Tainan, Tchaj-wan
- Yueh-Rong Nursing Home
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: 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.
|
|
|
Experimentální: 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.
|
The experimental group will receive an intervention comprising salivary gland massage combined with aromatherapy for a total of 20 days.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Dementia Feeding Difficulty Cues
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Oral Intake
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci úst
- Stomatognátní onemocnění
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Duševní poruchy
- Neurokognitivní poruchy
- Nemoci slinných žláz
- Demence
- Xerostomie
- Terapeutika
- Terapie mysli a těla
- Doplňkové terapie
- Psychoterapie
- Disciplíny a činnosti chování
- Smyslové umělecké terapie
- Fytoterapie
- Aromaterapie
Další identifikační čísla studie
- A-ER-114-511
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .