Aromatherapy, Dementia, Dry Mouth, Experimental, Feeding Difficulty, RCT
Conditions
Keywords
Dementia, Feeding Difficulty, Dual sensory stimulation
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.
Interventions
OTHERSMART 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.
Sponsors
National Cheng Kung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dementia Feeding Difficulty Cues | 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
| Measure | Time frame | Description |
|---|---|---|
| Oral Intake | 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. |
| Duration | 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. |
| Oral moisture | 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. |
| Body weight | 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. |
Countries
Taiwan
Outcome results
None listed