Protocol summary

Study aim
The purpose of this study was to determine the effect of horticultural therapy on the quality of life of elderly people admitted to day-care centers
Design
This study is a randomized clinical trial without blinding. In this study, 60 elderly people are randomly divided into intervention and control groups.
Settings and conduct
This study is done in day care centers of Mehr and Mina Sari elderly.Sample size: 60 subjects divided into intervention and control groups.Intervention: At first, the demographic characteristics questionnaire and the quality of life of the Lipad questionnaire by the control and intervention group before the intervention will be completed by the researcher Then, the intervention in gardening therapy will be held in 12 sessions for 6 weeks and each session of 30-45 minutes will be grouped together with the group of friends. It is worth mentioning that gardening is done in a pot and in daily centers.The first session involves familiarizing the members and expressing the logic and objectives of the training session. In the second session, familiarization with the seed and type of planting and how to irrigate .The third session of seed care training will be conducted in a group. The fourth session will be to visit the seeds and destroy the herbs. In the fifth session, the training is given and how the exploitation of the products is obtained، The sixth session will teach the properties of each seed to the elderly, Seventh session Review of planted vegetables and the attention of the elderly to their growthThe eighth session will teach the way of keeping vegetables, the ninth session of ripe vegetables is arranged and consumed and emphasized on the emotional relationship with plants,، The tenth and eleventh sessions will be repeated like the ninth session. At the twelfth session of the Lipid Quality of Life Questionnaire, the results of all these meetings will be written and analyzed.
Participants/Inclusion and exclusion criteria
The criteria for entry in this study are as follows: Having more than 60 years of age، Ability to do daily activities ، Having cognitive function ،Visit the Center daily at least in the last three months ، Interest in gardening activities، Loss of gardening activity for the elderly based on a doctor's diagnosis center، Exit criteria in this research include: Unwilling to participate in the study ، being admitted to the hospital، Missing more than 2 sessions، No referral to the daily care center، Change location
Intervention groups
Elderly people referred to the elderly's daily home after sampling and checking the entry and exit criteria Which includes: ability to do daily activities based on score 12-16 based on the psychometric evaluation of the Persian version of the daily activities of the elderly (ADL tool) and obtaining score 11 to 14 based on the psychometric evaluation of the Persian version of the instrument for daily activities of the elderly (IADL tool), performance Cognitive based on a score of above 7 in the AMT cognitive status test. Referring to the daily center at least in the past three months and interested in gardening activities, there is no loss of gardening activities for the elderly based on the physician's diagnosis. Output criteria in this study include the reluctance to participate Study, hospitalization, more absenteeism From 2 sessions, there is no referral to the day care center and change location
Main outcome variables
Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170611034454N3
Registration date: 2018-02-17, 1396/11/28
Registration timing: retrospective

Last update: 2018-02-17, 1396/11/28
Update count: 0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Ehteram Sadat Ilali
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.arab1388@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-30, 1396/10/09
Expected recruitment end date
2018-02-09, 1396/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of horticultural therapy on quality of life of elderly people admitted to day-care centers
Public title
horticultural therapy on quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having more than 60 years of age Ability to do daily activities based on 12 to 16 scores based on psychometric evaluation of the Persian version of the daily activities of the elderly (ADL tool and score 11 to 14 based on psychometric evaluation of the Persian version of the instrument of everyday life activities of the elderly (IADL tool) Having cognitive function based on a score above 7 in the AMT cognitive status test Visit the Center daily at least in the last three months Interest in gardening activities Loss of gardening activity for the elderly based on a doctor's diagnosis center
Exclusion criteria:
Unwilling to participate in the study Lack of interest in gardening activities Change Place No referral to the daily care center
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is a simple randomization, a unit is individualized, and the randomization tool uses a random number table.For sampling, each statistic population will be given a two-way code, and the table will be written based on the Weston line. Based on the decision of the researcher, one starts from a point in the table and moves to the right, up, or down, or left, and the samples will move to Completion of the number will be selected in the same way
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Clinical randomized trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, (vice chanchellor for research ), Moallem Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.MAZUMS.REC.1396.3170

Health conditions studied

1

Description of health condition studied
Quality of Life
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of Life
Timepoint
Before the intervention, after the intervention at the 12th session
Method of measurement
Lipad Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Includes elderly people referred to one of the elderly care centers. Then, the intervention in gardening therapy will be held in 12 sessions for 6 weeks and each session of 30-45 minutes will be grouped together with the group of friends. The first session involves familiarizing the members and expressing the logic and objectives of the training session. In the second session, familiarization with the seed and type of planting and how to irrigate .The third session of seed care training will be conducted in a group. The fourth session will be to visit the seeds and destroy the herbs. In the fifth session, the training is given and how the exploitation of the products is obtained، The sixth session will teach the properties of each seed to the elderly, Seventh session Review of planted vegetables and the attention of the elderly to their growthThe eighth session will teach the way of keeping vegetables, the ninth session of ripe vegetables is arranged and consumed and emphasized on the emotional relationship with plants,، The tenth and eleventh sessions will be repeated like the ninth session. At the twelfth session of the Lipad Quality of Life Questionnaire, the results of all these meetings will be written and analyzed.It is worth noting that vegetable work will be done in the pot.
Category
Other

2

Description
Control group: Includes elderly people who come to another center. No action will be taken for them, and routine care will receive daily centers, and only the questionnaires will be completed at the same time as the intervention group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Day care center for the elderly SARA Mehr
Full name of responsible person
Fatemeh Alipour
Street address
Imam Reza Blvd., Imam Reza 4, Center for Comprehensive Rehabilitation of Sara Mehr
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3327 2040
Email
f.alipour76@gmail.com

2

Recruitment center
Name of recruitment center
Mina's Senior Day Care Center
Full name of responsible person
Fatemeh Alipour
Street address
Myrzamani Street, Mina's Senior Citizen's Daily Center
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3332 4121
Email
f.alipour76@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Research Vice-President of Mazandaran University of Medical Sciences, Moalem Square,
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3304 4001
Fax
+98 11 3336 2569
Email
f.alipour76@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Alipour
Position
Graduate Student, Old age nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nasibe Nursing and Midwifery Faculty, Vesal Street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 4224 8488
Email
f.alipour76@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ehteram Sadat Ilali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
vesal street ,Nasibe Nursing and Midwifery Faculty
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7374
Fax
+98 11 3336 7374
Email
paradis2082000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Alipour
Position
Graduate student, Old age nursing
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Vesal street, Nasibe nursing and midwifery faculty
City
Sari
Province
Mazandaran
Postal code
2162738937
Phone
+98 11 4224 8488
Fax
+98 11 4224 8488
Email
f.alipour76@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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