UMIN-CTR Clinical Trial

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 Obsterics 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
Email	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
Email	chiai-Oi@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055525