Provides a simple executive solution to improve the quality of life for patients with diabetes
Design
Randomized clinical trials, double blind, single center
Settings and conduct
The present study was conducted at the Malayer diabetes center and on people with diabetes. Samples and data analyzers did not know how to place the samples in the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having diabetes; complete awareness of time, place, and individuals; age range 18 to 65 years; the desire to participate in the study
Exclusion criteria: Unwilling to participate in the study; inability to reading and writing
Intervention groups
Intervention group: The intervention included holding group spiritual care sessions for the intervention group during 5 sessions of 45 to 60 minutes based on spiritual-religious strategies.
Control group: The control group did not receive any interventions during this intervention period, except for standard treatment measures.
Main outcome variables
Quality of life for diabetic patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161223031522N7
Registration date:2018-02-24, 1396/12/05
Registration timing:retrospective
Last update:2018-02-24, 1396/12/05
Update count:0
Registration date
2018-02-24, 1396/12/05
Registrant information
Name
Vahid Naseri Salahshour
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
v.naserisalahshour@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-11-01, 1394/08/10
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
2015-11-01, 1394/08/10
Actual recruitment end date
2016-11-30, 1395/09/10
Trial completion date
empty
Scientific title
The effect of spiritual care on quality of life in patients with diabetes
Public title
The effect of spiritual care on quality of life in patients with diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from diabetes mellitus
Complete awareness of time, place, and individuals
18 to 65 years old
The desire to participate in the study
Exclusion criteria:
Unwilling to participate in the study
Inability to reading and writing
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
112
Actual sample size reached:
112
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are divided into intervention and control groups using randomized block allocation method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Samples and data analyzers did not know how to allocate to intervention and control groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Rah ahan Sq, Aalam alhoda St
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2015-10-02, 1394/07/10
Ethics committee reference number
IR.ARAKMU.REC.1394.189
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Quality of life in patients with diabetes
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
SF36 standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the intervention included holding spiritual group meetings for the intervention group during 5 sessions of 45 to 60 minutes based on spiritual-religious strategies.
Category
Lifestyle
2
Description
Control group: the control group samples did not receive any interventions during this intervention period except for standard treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Malayer diabetes center
Full name of responsible person
Karim Mirzaei
Street address
Nabovat Blvd.
City
Malayer
Province
Hamadan
Postal code
6488165718
Phone
+98 81 3525 0182
Email
Mehr.hospital87@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Basij Sq, Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3638
Email
Rsearch@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Basij Sq, Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
m.sajadi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Basij Sq, Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
m.sajadi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Naseri Salahshour
Position
Msc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij Sq, Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
vahidnaseri1994@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on the main outcome and the demographic information, can be shared after unidentifiable of people.
When the data will become available and for how long
The beginning of the access period is 12 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to utilize scientific purposes and mention the source used.
From where data/document is obtainable
Dr Mahboubeh Sajjadi, Ph.D. of Nursing, Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.
E-mail address: sajadimahbobeh@yahoo.com
What processes are involved for a request to access data/document
After receiving the email from the requester, the information will be sent within 2 to 3 business days.