The aim of this study was to determine the effect of agriculture activities on positive and negative symptoms and quality of life in hospitalized chronic schizophrenic patients. This study was a clinical trial, single center, with random allocation. The population of the study was the eligible chronic schizophrenic patients hospitalized in Sina Hospital in Joneghan. Inclusion criteria was diagnosis of chronic schizophrenia. The patients with mental retardation or change in the treatment regimen during the study were excluded. Fifty-two patients were randomly allocated in agriculture therapy or control (routine treatment) groups (26 in each group). The patients in control group received routine anti-psychotic treatment (4 mg risperidone tablet three times a day). The patients in agriculture group, participated in daily agriculture activities in addition to routine medication. The intervention was conducted for three months. The patients’ positive and negative symptoms and quality of life were evaluated at the beginning and the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501042085N15
Registration date:2015-12-11, 1394/09/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-11, 1394/09/20
Registrant information
Name
Neda Parvin
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5652
Email address
nedali285@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2014-04-19, 1393/01/30
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of agriculture activities on positive and negative symptoms and quality of life in hospitalized chronic schizophrenic patients
Public title
Effect of agriculture activities on positive and negative symptoms and quality of life in hospitalized chronic schizophrenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Physical ability; the diagnosis of chronic schizophrenia according to DSM IV TR criteria; aged between 18 and 80 years old
Exclusion criteria: Mental retardation; change in the treatment regimen during the study
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was performed with a computer-generated sequence of random
numbers using SPSS software 16.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Approval date
2013-08-01, 1392/05/10
Ethics committee reference number
92-5-10
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20.5
ICD-10 code description
Residual schizophrenia
Primary outcomes
1
Description
Positive and negative symptoms
Timepoint
At the beginning and the end of the study
Method of measurement
Anderson's positive and negative symptoms Scale
2
Description
Quality of life
Timepoint
At the beginning and the end of the study
Method of measurement
Schizophrenia quality of life scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The patients in this group were under treatment with anti-psychotic medication with 4 mg risperidone tablet three times a day.
Category
Treatment - Drugs
2
Description
Agriculture group: The patients in this group, participated in daily agriculture activities for three months in addition to treatment with risperidone tablet (rispridone tablet 4 mg three times a day).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Neda Parvin
Street address
City
Joneghan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr.Sayed Kamal Solati
Street address
Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 5652
Fax
Email
np285@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 5652
Fax
Email
np285@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 5652
Fax
Email
np285@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)