Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061579) titled 'Evaluation of the Effects of Aromatherapy on Elderly Residents in Care Facilities' on May 14.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - University of Occupational and Environmental Health

Condition: Condition - We will conduct a comprehensive evaluation of the sleep-improving effects of hand massages using lavender essential oil by combining objective assessment metrics with physiological indicators. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - We will verify the sleep-improving effects of hand massage using lavender essential oil by measuring salivary oxytocin levels over time. Basic objectives2 - Others

Intervention: Interventions/Control_1 - 1.Adjust to each participant's sleep schedule. The intervention is conducted at the time each night when the participant lies down in bed to fall asleep. The aromatherapy oil used for the hand massage consists of a 1% dilution of lavender essential oil (manufactured by Seikatsunoki,sourced from France) mixed with clear jojoba oil (manufactured by Seikatsunoki). 2.Massage: Perform light stroking for 5 minutes per hand, covering the area from the palm to the elbow joint, for a total of 10 minutes per person. 3. Frequency and Duration of Intervention: Massage is performed three times a week, every other day (e.g., Mon-Wed-Fri or Tue-Thu-Sat),for two consecutive weeks, with a trained researcher consistently performing the treatment. Interventions/Control_2 - In addition to measuring sleep patterns using the objective sleep indicator Sensor Mat Sleep Monitor (Minori SCAN), the device also measures autonomic nervous system activity based on heart rate and respiratory rate. The high-sensitivity sensors of the Minori SCAN, placed under the mattress, detect subtle vibrations such as body movements to measure sleep and wakefulness.

Eligibility: Age-lower limit - 65 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Individuals aged 65 or older residing in a senior care facility (regardless of gender) 2. Individuals for whom consent has been obtained from both the participant and their family (or legal representative) 3. Individuals who tested negative on an aromatherapy oil patch test 4. Individuals exhibiting BPSD symptoms Key exclusion criteria - Any person who does not meet even one of the selection criteria Target Size - 35

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 14 Day Date of IRB - 2026 Year 04 Month 14 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070452

Disclaimer: Curated by HT Syndication.