UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050224 |
|---|---|
| Receipt number | R000057196 |
| Scientific Title | A Non-Randomized Controlled Trial to Determine the Effect of Livestock on the Motivation and Anxiety of Patients with Chronic Schizophrenia |
| Date of disclosure of the study information | 2023/02/02 |
| Last modified on | 2023/02/02 21:54:43 |
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Basic information
Public title
A Non-Randomized Controlled Trial to Determine the Effect of Livestock on the Motivation and Anxiety of Patients with Chronic Schizophrenia
Acronym
SHEEP REARING AND PATIENTS WITH SCHIZOPHRENIA
Scientific Title
A Non-Randomized Controlled Trial to Determine the Effect of Livestock on the Motivation and Anxiety of Patients with Chronic Schizophrenia
Scientific Title:Acronym
SHEEP REARING AND PATIENTS WITH SCHIZOPHRENIA
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychosomatic Internal Medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to implement a livestock-based business development project in collaboration with Agricultural Fortune (Ishikawa Lamb) and evaluate the future employment possibilities for patients with schizophrenia. This project incorporates the operational process of the sheep-rearing business, from breeding to meat processing, into the employment support activities conducted at welfare establishments and provides experiential learning on sheep-rearing to patients with mental disorders. This study includes a preliminary survey conducted to examine the effect of a one-day sheep-rearing experiential learning program on the work motivation and anxiety of people with chronic schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Participants were provided with an explanation for saliva collection before conducting the procedure. Thirty minutes prior to the collection, the participants were not allowed to smoke, eat, or exercise and, during the procedure, an instructor was assigned to guide them and confirm that the precautions were followed. A special saliva collection sponge (Salivette, Sarstedt) was used.26 The mouth was lightly rinsed with water and the sponge was placed in it; patients were asked to thoroughly chew it for 2 minutes to soak up the saliva. STAI was self-administered simultaneously.
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The activity started at 8:30 AM on both days. We arrived at the experience site by bus on the intervention day and initiated the experiential learning program at 10:30 AM (Figure 2). The main activities included feeding and herding the sheep and cleaning the sheep-pens in the facility. On the control day, the participants gathered at the venue by 8:30 AM, communicated with each other, performed morning exercises, and health checks were conducted. Exercise and occupational therapy were performed in the morning and afternoon. The activity end time was 15:00 PM on both days. The survey and saliva collection were conducted twice, at 10:00 AM and 15:00 PM. All participants were assigned an employment support staff-in-charge. The burden of work was equally distributed, and the amount of work was not biased.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study will be conducted with persons with intellectual disabilities ranging from mild B1 to moderate B2 and mental disabilities of 51 or higher on the GAF (Global Assessment of Functioning) scale (most users have both disabilities). Users who can clearly express their willingness to participate in the study and who are able to take part in the cerebral blood flow tests and questionnaires (interviews) administered by the researchers will be included in the study.
Key exclusion criteria
Patients who do not have a selection criteria
Patients who are allergic to animals.
Patients who have negative reactions to animals.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nobuko |
| Middle name | |
| Last name | Shimizu |
Organization
Toyama Prefectural University
Division name
Faculty of Nursing
Zip code
930-0975
Address
2-2-78 Nishinagae, Toyama City, Toyama Prefecture
TEL
0764645410
n-shimizu@pu-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Nobuko |
| Middle name | |
| Last name | Shimizu |
Organization
Toyama Prefectural University
Division name
Toyama Campus Office
Zip code
930-0975
Address
2-2-78 Nishinagae, Toyama City, Toyama Prefecture
TEL
0764645410
Homepage URL
tpukango_rinri@pu-toyama.ac.jp
Sponsor or person
Institute
Toyama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Bio-oriented Technology Research Advancement Institution
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
Toyama Prefectural University
Address
2-2-78 Nishinagae, Toyama City, Toyama Prefecture
Tel
0764645410
n-shimizu@pu-toyama.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2023 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057196
