UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048734 |
|---|---|
| Receipt number | R000055525 |
| Scientific Title | Effectiveness of animal assisted therapy in a university hospital |
| Date of disclosure of the study information | 2022/08/24 |
| Last modified on | 2022/08/23 21:00:54 |
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Basic information
Public title
Effectiveness of animal assisted therapy in a university hospital
Acronym
Effectiveness of animal assisted therapy
Scientific Title
Effectiveness of animal assisted therapy in a university hospital
Scientific Title:Acronym
Effectiveness of animal assisted therapy
Region
| Japan |
Condition
Condition
palliative medicine
Classification by specialty
| Medicine in general | Psychosomatic Internal Medicine | Surgery in general |
| Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Objectively evaluate the effects of Animal Assisted Therapy (AAT)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To examine whether stress markers in saliva (amylase concentration, free cortisol concentration, oxytocin) change before and after the intervention of Animal Assisted Therapy (AAT).
Key secondary outcomes
We will also evaluate mood changes by psychological tests using questionnaires and improvement of pain using face scales before and after the intervention of Animal Assisted Therapy (AAT).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Before and after the introduction of Animal Assisted Therapy (AAT), mood changes by psychological tests using questionnaires, evaluation of pain using face scales, salivary stress indicators (amylase concentration, free cortisol concentration, oxytocin) is measured and compared.
Interventions/Control_2
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
| 5 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have provided sufficient verbal and written explanations regarding this clinical trial at the time of examination and have obtained written informed consent.
Key exclusion criteria
Patients who do not consent to participate in this study.
Patients with low salivation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Chiai |
| Middle name | |
| Last name | Nagae |
Organization
St.Marianna University School of Medicine
Division name
pediatrics
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511 Japan
TEL
044-977-8111
chiai-Oi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Chiai |
| Middle name | |
| Last name | Nagae |
Organization
St.Marianna University School of Medicine
Division name
pediatrics
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511 Japan
TEL
044-977-8111
Homepage URL
chiai-Oi@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology.
Grant-in-Aid for Scientific Research
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511 Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 24 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 23 | Day |
Last modified on
| 2022 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055525
