UMIN-CTR Clinical Trial

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

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name	Toshihiko
Middle name
Last name	Yusa

Organization

Nara Medical University

Division name

MBT Institute

Zip code

634-8521

Address

840, Shijocho, Kashihara-shi, Nara

TEL

0744-29-8958

Email

yusa@naramed-u.ac.jp

Name of contact person

1st name	Toshihiko
Middle name
Last name	Yusa

Organization

Nara Medical University

Division name

MBT Institute

Zip code

634-8521

Address

840, Shijocho, Kashihara-shi, Nara

TEL

0744-29-8958

Homepage URL

Email

yusa@naramed-u.ac.jp

Institute

MBT Institute, Nara Medical University

Institute

Department

Personal name

Organization

Nara Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institute for Clinical and Translational Science Nara Medical University

Address

840, Shijocho, Kashihara-shi, Nara

Tel

0744-22-3051

Email

kanae123@naramed-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

11

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

41

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

11

Month

27

Day

Date of IRB

2018

Year

11

Month

14

Day

Anticipated trial start date

2018

Year

11

Month

30

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

11

Month

27

Day

Last modified on

2019

Year

12

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039299

Single case data URL

Value
https://center6.umin.ac.jp/ice/39299