UMIN ID: UMIN000047594
Registered date:26/04/2022
Study on the effects of long-term intervention of a home robots on stress reduction.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Healthy adults |
| Date of first enrollment | 2022/05/20 |
| Target sample size | 10 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Subjects spend 15 minutes with the home robot "LOVOT(R)" (GROOVE X Co., Ltd.) before bedtime every day for six weeks. Saliva sampling and autonomic nerve balance measurement based on pulse wave fluctuations using the acceleration pulse wave measuring device "TAS9 VIWE RW" (YKC Co., Ltd.) are conducted three times a week (Monday, Wednesday, Friday), and a questionnaire survey on mental state using the Visual Analog Scale (VAS) is conducted once a week (Wednesday). |
Outcome(s)
| Primary Outcome | Visual Analog Scale (VAS) values of subjective mental changes (I feel irritated, I have worries, I feel tense, I feel nervous, I have anxiety, I am depressed.) |
|---|---|
| Secondary Outcome | 1) Concentration of physiologically active substances in saliva (oxytocin, secretory immunoglobulin A (s-IgA)) 2) Autonomic balance index based on pulse wave (heart rate) variability analysis |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | 1) Subjects aged 18 to 65 at the time of consent. 2) Subjects who have been informed of the contents of this study and have confirmed their consent in the consent form. |
| Exclude criteria | 1) Subjects with a diagnosis of arrhythmia 2) Subjects who have a cardiac pacemaker. 3) Subjects who currently smoke on a daily. |
Related Information
| Primary Sponsor | Tokyo University of Pharmacy and Life Sciences |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Sadahiko Shimoeda |
| Address | 1432-1 Horinouchi, Hachioji, Tokyo Japan 192-0392 |
| Telephone | 042-676-6697 |
| shimoeda@toyaku.ac.jp | |
| Affiliation | Tokyo University of Pharmacy and Life Sciences Department of Pharmacy Pharmaceutical Care and Sciences |
| scientific contact | |
| Name | Sadahiko Shimoeda |
| Address | 1432-1 Horinouchi, Hachioji, Tokyo Japan |
| Telephone | 042-676-6697 |
| shimoeda@toyaku.ac.jp | |
| Affiliation | Tokyo University of Pharmacy and Life Sciences Department of Pharmacy Pharmaceutical Care and Sciences |