Effect of inhalation aromatherapy with Japanese essential oil during bedtime on worker's subjective sleep quality, daytime sleepiness, and fatigue

JRCT ID: jRCT1050230170

Registered date:26/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Improvement of sleep quality
• Date of first enrollment: 26/01/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

We set control and intervention conditions and conduct a crossover trial.
The control condition: Participants sleep wearing an inhalation patch with distilled water (0.05-0.1mL) on their chest every night during bedtime from Sunday to Thursday.
The intervention condition: Participants sleep wearing an inhalation patch with kuromoji (Lindera umbellata) essential oil (0.05-0.1mL) on their chest every night during bedtime from Sunday to Thursday.
In both conditions, participants answer the following questionnaires on Monday, Wednesday, and Friday: OSA sleep inventory MA version when waking up, and Japanese version of the Epworth Sleepiness Scale and Jikaku-sho shirabe during daytime.
Participants answer pre-intervention questions during the informed consent process and post-intervention questions after completing the entire process.

Outcome(s)

Primary Outcome

The measurements are subjective feeling of sleep, daytime sleepiness, and fatigue.
Questionnaires such as OSA sleep inventory MA version, Japanese version of the Epworth Sleepiness Scale, and Jikaku-sho shirabe that is a questionnaire to assess fatigue are used.

Secondary Outcome

The following questions are asked to understand the attributes of the research subjects and gather information on their aromatic bath habits and impressions on the scent of kuromoji (Lindera umbellata) essential oil.
Before intervention
Age, sex, past medical history, the presence of taking sleep medicine, the type of medicine, the presence of pregnancy and/or breastfeeding, the presence of experience and/or habits of aromatherapy, the presence of experience of mental and/or physical abnormalities due to aromatherapy, sleep duration on weekdays, subjective sleep quality, and any additional comments or concerns.
After intervention
Participant's impressions of the scent of kuromoji (Lindera umbellata) essential oil and any additional comments or concerns.

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: <= 65age old
• Gender: Both
• Include criteria: Healthy individuals aged 30 to 65 who work full-time during the daytime on weekdays.

Exclude criteria

Individuals who have subjective symptoms or treatments such as Narcolepsy, idiopathic hypersomnia, Kleine Levin Syndrome, circadian rhythm sleep disorder, sleep apnea syndrome, restless legs syndrome, periodic limb movement disorder, somnambulism, sleep terrors, REM sleep behavior disorder, mental illness, other sleep-disturbing symptoms, olfactory disorders and plant allergies.
Those who take sleeping pills and/or prescription drugs that cannot be used with aromatherapy.
Those who are pregnant or breastfeeding. Those who may be pregnant.
Those who have been aware of mental and/or physical abnormalities due to aromatherapy.
Those who dislike the scent of kuromoji (Lindera umbellata) essential oil.

Related Information

• Primary Sponsor: Shinohara Yasushi