The effect of spiritual care on body image in patients with type 2 diabetes-related amputation attending to the Isfahan Al Zahra hospital clinics and rehabilitation centers in 2014
Objectives: This study was conducted to investigate the effect of spiritual care on body image in patients with type 2 diabetes-related amputation.
Design: In this study an experimental pretest-posttest design with two experimental groups was used. A number of 60 participants aged between 40 and 72 who had diabetes-related amputation took part in the study. The participants were randomly assigned to meditation and control group
Setting and conduct: For experimental group, three sessions of meditation and for control group, three sessions about prevention of diabetic foot ulcer were held. The participants in experimental group were asked to perform meditation exercises for a month. The data was collected via Amputee Body Image Scale (ABIS), before and 4 weeks after the intervention.
Participants: In this study participants were people who were older than 18 years who have amputations due to diabetes type 2; Patients with type 2 diabetes caused the amputation of toes, ankle, below the knee; At least 3 months have passed since the amputation
Main outcome measures: In this study Body Image, Quality of Life and Spiritual Health were evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090219015N1
Registration date:2015-08-22, 1394/05/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-22, 1394/05/31
Registrant information
Name
Malihe Imeni
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2951
Email address
malihe.imeni@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-10-20, 1393/07/28
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual care on body image in patients with type 2 diabetes-related amputation
Public title
The effect of spiritual care on body image
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Patients older than 18 years who have amputations due to diabetes type 2; Patients with type 2 diabetes caused the amputation of toes, ankle, below the knee; At least 3 months have passed since the amputation; Lack of use of complementary medicine practices in the past three months; patients who are interested in participating in the study; Patients who have allowed by their specialist to participate in the study; patients who are fluent in Farsi; patients who have literacy; Patients with no mental retardation, blindness and deafness; Patients who don’t have active mental disorders based on their specialist diagnosis; Patients who have audio and video features to use of educational CD
exclusion criteria:Patients remain on study at least 75% of the time specified interventions are done, otherwise they will be excluded; If patients do not have the desire to continue to participate in the study; In case of any problems so that the subjects were not able to participate in the study.
Age
From 18 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
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jarib street, Azadi Square, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2014-10-15, 1393/07/23
Ethics committee reference number
393479
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E10,E11,E1
ICD-10 code description
With neurological complications
Primary outcomes
1
Description
Body image
Timepoint
before intervention- Immediately after intervention
Method of measurement
standard questionnaire of amputee body image scale
2
Description
Quality of Life In Diabetic Patients
Timepoint
before intervention- Immediately after intervention
Method of measurement
Standard Questionnaire of Diabetic Quality of Life
3
Description
Spiritual Health
Timepoint
before intervention- Immediately after intervention
Method of measurement
Standard Questionnaire of Spiritual Health
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: spiritual care consist of meditation training, and repeat meditation for 4 weeks and every day 15 minutes
Category
Other
2
Description
control group:Holding 3 training sessions in relation to health care and general tips on diabetic foot
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital of Isfahan
Full name of responsible person
Malihe Imeni
Street address
Isfahan University of Medical Sciences, Hezar jarib street, Azadi Square, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Fakhri Sabohi
Street address
Isfahan University of Medical Sciences, Hezar jarib street, Azadi Square, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan 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
Isfahan University of Medical Sciences, nursing & midwifery faculty
Full name of responsible person
Malihe Imeni
Position
Student of postgraduate nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jarib street, Azadi Square, Isfahan, Iran
City
Isfahan
Postal code
Phone
+31 37922951
Fax
Email
malihe.imeni@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, nursing &midwifery faculty
Full name of responsible person
Malihe Imeni
Position
Student of postgraduate nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jarib street, Azadi Square, Isfahan, Iran
City
Isfahan
Postal code
Phone
+31 37922951
Fax
Email
malihe.imeni@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)