The study of the effect of religious-spritual interveation on spiritual health, self care activities and quality of life in patients with type 2 diabetes in Shiraz Shahid motahari Clinic , 2017-2018
Design
Obtaining an introduction letter from the authorities at the School of Nursing and Midwifery,University of Medical Sciences and presenting to the clinic – Sample selection by simple random sampling and obtaining informed consent – Completion of questionnaires for demographic characteristics, spiritual health, self-care activities and quality of life by both case and control groups before intervention – Simple block randomization and determination of case and control group members – for the intervention group, 6 sessions of 45-60 minutes once a week for 6 weeks – No intervention was performed in the control group; this group received only the routine care provided by the diabetes clinic - Completion of questionnaires for demographic characteristics, spiritual health, self-care activities and quality of life by both case and control groups one month following intervention – Data analysis.
Settings and conduct
Diabetes Clinic in Motahhari Clinic, Shiraz
Participants/Inclusion and exclusion criteria
Diabetic patients aged 18-60 years old - No history of amputation- Desire to receive spiritual interventions - Residency in Shiraz -
Being under medical treatment - Ability to understand Persian language - HbA1c level less than 8 /.
Intervention groups
Six one-hour special conversation sessions regarding spiritual topics
Main outcome variables
Change in self-care activities and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171113037441N2
Registration date:2018-02-16, 1396/11/27
Registration timing:retrospective
Last update:2018-02-16, 1396/11/27
Update count:0
Registration date
2018-02-16, 1396/11/27
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5328 0471
Email address
tabatabeih@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-09-29, 1396/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Spiritual-Religious Intervention on Spiritual Health, Self-care Activities and Quality of Life in Patients with Type 2 Diabetes
Public title
The effect of spiritual health on the quality of life of diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients aged 18-60 years old
Desire to receive spiritual interventions
Residency in Shiraz
Being under medical treatment
Ability to understand Persian language
HbA1c level less than 8 /
Exclusion criteria:
History of amputation
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The method under use is simple randomization, and the unit of randomization is individual
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
123456
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
1396.107.IR.SUMS.REC
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11.65
ICD-10 code description
Type 2 diabetes mellitus with hyperglycemia
Primary outcomes
1
Description
Self-care score
Timepoint
After the end of the intervention
Method of measurement
questionnaire
2
Description
Mental health
Timepoint
After the end of the intervention
Method of measurement
questionnaire
3
Description
Quality of Life
Timepoint
After the end of the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Religious spiritual intervention is held through 6 one hour sessions. This interventions are based on the Richards and Bergin model.
Category
Lifestyle
2
Description
Control group: in this group will not be any intervention.