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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035037
Receipt No. R000039299
Scientific Title A study on psychological and fatigue recovery effect of horticultural therapy using medicinal crops and rural area walking
Date of disclosure of the study information 2018/11/29
Last modified on 2018/11/27

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Basic information
Public title A study on psychological and fatigue recovery effect of horticultural therapy using medicinal crops and rural area walking
Acronym A study on psychological and fatigue recovery effect of horticultural therapy using medicinal crops and rural area walking
Scientific Title A study on psychological and fatigue recovery effect of horticultural therapy using medicinal crops and rural area walking
Scientific Title:Acronym A study on psychological and fatigue recovery effect of horticultural therapy using medicinal crops and rural area walking
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study focuses on horticultural therapy using medicinal crops and walking in rural areas and examines the presence and extent of fatigue recovery and psychological effects on participants, thereby developing new programs in rural health tourism, Furthermore, it aims to accumulate medical evidence for the revitalization of agriculture and rural areas.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1 Measure and quantify the flicker value (flickering degree of eyes) before and after each farm work, region walks, each action. Measure before and after the action, determine the average value and standard deviation of each, and judge whether the interval scale has changed significantly.
2 Evaluate mental health by farm work, regional walks, mood profile survey before and after each act (POMS 2 simplified version). Disease verification is performed by conducting TMD score conversion, judging that improvement can be expected if the average value of the score rate and the standard deviation of individuals are obtained and each decreases before and after the tour.
Key secondary outcomes 3 Health status is evaluated by regional walks, regional walks, and a gaseous water score (questionnaire on 65 items) before and after each action.
4 Utterance recorded during the act is categorized using the text mining technique and contents of the utterance is categorized and the number of utterances per category and its change are analyzed to judge the presence or absence of emotional change.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Horticultural therapy using medicinal crops such as Angelica
Interventions/Control_2 Horticultural therapy using non medicinal crops
Interventions/Control_3 Walking through rural areas
Interventions/Control_4 Walking through urban areas
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
65 years-old >
Gender Male and Female
Key inclusion criteria Age 20 years and over, under 65 years (when registering) Healthy adults
Key exclusion criteria Walking movement, agricultural work experience etc, enough physical strength is needed, excluding those who are not healthy. Also, excluding those who can not obtain consent, those who could not participate on the day, those who retired on the day they could participate.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Yusa
Organization Nara Medical University
Division name MBT Institute
Zip code
Address 840, Shijocho, Kashihara-shi, Nara
TEL 0744-29-8958
Email yusa@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Yusa
Organization Nara Medical University
Division name MBT Institute
Zip code
Address 840, Shijocho, Kashihara-shi, Nara
TEL 0744-29-8958
Homepage URL
Email yusa@naramed-u.ac.jp

Sponsor
Institute MBT Institute, Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
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
Address
Tel
Email

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
2018 Year 11 Month 29 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
2018 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2018 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039299

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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