JRCT ID: jRCTs051210031
Registered date:02/06/2021
A study of the chamomile on sleep quality.
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Person with any condition that causes a need for care in welfare facilities for older people, etc. |
Date of first enrollment | 03/07/2021 |
Target sample size | 19 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Chamomile essential oil 1.2g / day or air is released intermittently once a day from bedtime to waking up for 7 consecutive days. |
Outcome(s)
Primary Outcome | Sleep quality: Changes in the score of the Pittsburgh Sleep Questionnaire revised from the original to the one-week version (change from the score on the first day of the release observation period as the baseline to the score on the first day of the post-release observation period ). |
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Secondary Outcome | Effectiveness evaluation outcomes: Changes in the time of wake-up in the sleep period that is counted by the heart rate and respiratory rate measured by the under-bed sensor. (change from the total time during the pre-release period as the baseline to the total time during the release period) Safety evaluation outcomes: Incidence of diseases during the observation period. |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Resident of welfare facilities for older people, etc. 2. Person aged 20 years old or older. 3. Person with Pittsburgh Sleep Questionnaire Quality Index of 2 or higher 4. Person with no willingness to change the drug being taken during the study period. 5. Person who voluntarily consented to the document regarding participation in this study. |
Exclude criteria | 1. Person with drug hypersensitivities such as aromas of essential oils. 2. Pregnant and lactating woman, or woman of childbearing potential. 3. Person inappropriately participating in this study at the discretion of the person in charge of this study. |
Related Information
Primary Sponsor | Okayama Masanobu |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Masanobu Okayama |
Address | 2-1-5 Arata-cho, Hyogo-ku, Kobe, Hyogo Hyogo Japan 652-0032 |
Telephone | +81-78-382-6732 |
okayamam@med.kobe-u.ac.jp | |
Affiliation | Kobe University Graduate School of Medicine |
Scientific contact | |
Name | Masanobu Okayama |
Address | 1-14-1 Agatsuma-cho, Hirohata-ku, Himeji, Hyogo Hyogo Japan 671-1154 |
Telephone | +81-79-238-5725 |
okayamam@med.kobe-u.ac.jp | |
Affiliation | Cosmos Village Hirohata |