UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043554 |
|---|---|
| Receipt number | R000049743 |
| Scientific Title | Psychological effects of animal-assisted therapy |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2023/03/13 09:26:07 |
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Basic information
Public title
Psychological effects of animal-assisted therapy
Acronym
Effects of animal-assisted therapy
Scientific Title
Psychological effects of animal-assisted therapy
Scientific Title:Acronym
Effects of animal-assisted therapy
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the psychological effects of animal friendly environments such as Animal-assisted therapy among adults with psychological disorder.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mental health such as heart rate variability, blood pressure variability, body temperature variability, sleep duration time, physical activity level.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Animal-assisted therapy
Interventions/Control_2
Control without Animal-assisted therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults without experience for animal-assisted therapy in last 3 months
Key exclusion criteria
Nothing
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Taniguchi |
| Middle name | |
| Last name | Yu |
Organization
National Institute for Environmental Studies
Division name
Center for Health and Environmental Risk Research
Zip code
305-8506
Address
16-2 Onogawa, Tsukuba, Ibaraki
TEL
029-850-2359
taniguchi.yu@nies.go.jp
Public contact
Name of contact person
| 1st name | Taniguchi |
| Middle name | |
| Last name | Yu |
Organization
National Institute for Environmental Studies
Division name
Center for Health and Environmental Risk Research
Zip code
305-8506
Address
16-2 Onogawa, Tsukuba, Ibaraki
TEL
029-850-2359
Homepage URL
taniguchi.yu@nies.go.jp
Sponsor or person
Institute
National Institute for Environmental Studies
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute for Environmental Studies
Address
16-2 Onogawa, Tsukuba, Ibaraki
Tel
+81(29)850-2359
taniguchi.yu@nies.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
Results
In this study, the 8 patricipants in the intervention groups were analyzed.
Results date posted
| 2023 | Year | 03 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The age distribution of the participants was almost the same between the ages of 10 and 60. The sex of the participants was female only. 62.5% of participants had mental illness and 37.5% had intellectual disability.
Participant flow
Co-researchers of this research explained the contents of the research to candidate subjects in writing and orally, and selected participants.
Adverse events
There were reports of skin troubles caused by wearing devices (wearable devices).
Outcome measures
"Degree of attachment to dogs", "Thoughts about working with dogs", "Subjective health", "Stress", "Mental health", "Happiness", and "Sleep" evaluated by self-administered questionnaire, and "step count", "calorie consumption", and "sleep time" evaluated by wearable devices.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2023 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049743
