Protocol summary

Summary
Objective: The study aimed to investigate the effects of massage therapy on glyceamic control (FBS, HBA1C) in women with diabetes at primary health care center in Iran. Design: The study population comprised fifty women. with type 2 diabetes selected by convenience sampling and then randomization was done using block random sampling which divided into control and test groups. The test group (25 patients) received massage 30 min, weekly for 10 sessions and the control group (25 patients) received standard care Glyceamic control indexes include (HbA1C, FBS) was measured at baseline, after 10 weeks of therapy with in groups and between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013072614168N1
Registration date: 2013-09-20, 1392/06/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-09-20, 1392/06/29
Registrant information
Name
Mahboobeh Ghasemipoor
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 2527 4698
Email address
ghasemipoor@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of massage therapy on glyceamic control (FBS & HBA1C) in women with type 2 diabetes
Public title
Effect of massage on blood glucose on diabetes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria were: women with type 2 diabetes and HbA1c of ≥7%, with oral anti-diabetic treatment were included Exclusion criteria were heart failure or renal failure, and insulin treatment for the type 2 diabetes.
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Isfahan University of Medical Sciences
Street address
Hezar Jarib, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Iran
Approval date
2013-02-16, 1391/11/28
Ethics committee reference number
392009

Health conditions studied

1

Description of health condition studied
diabetes type 2
ICD-10 code
E 11
ICD-10 code description
non-insulin-dependent

Primary outcomes

1

Description
HbA1C
Timepoint
per intervention and after
Method of measurement
percent i by auto analyzor

2

Description
FBS
Timepoint
before and after intervention
Method of measurement
mgr/dli by auto analyzor

Secondary outcomes

1

Description
HBA1C and FBS
Timepoint
before and after intervention
Method of measurement
percent and mg/dlit by auto analysore

2

Description
HBA1C and FBS
Timepoint
before and after intervention
Method of measurement
percent and mg/dlit with auto analyser

Intervention groups

1

Description
Intervention group:10 session massage therapy weekley 30 minutes plus standard care Control group:standard care in diabetes center
Category
Other

2

Description
Intervention group:massage therapy weekly at 30 minutes in ten sesions Control group:standard care of diabetes center
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Sajad diabetes center
Full name of responsible person
Ghasemipoor
Street address
Isfahan Nursing and Miidwifery School
City
Isfahan

2

Recruitment center
Name of recruitment center
Imam Sajad diabetes center
Full name of responsible person
Ghasemipoor
Street address
Isfahan Nursing and Midwifery School
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Maryam Kianpour
Street address
Isfahan University and Midwifery School
City
Isfahan
Grant name
Grant code / Reference number
392009
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Science
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
Full name of responsible person
Ghasemipoor Mahboobeh
Position
MS of Nursing
Other areas of specialty/work
Street address
Isfahan Nursing and Midwifery School
City
Isfahan
Postal code
Iran
Phone
+98 31 2527 4698
Fax
+98 31 1792 2934
Email
ghasemipoor@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Samereh Abdoli
Position
PHD of Nursing
Other areas of specialty/work
Street address
Isfahan Nursing and Midwifery School
City
Isfahan
Postal code
Iran
Phone
+98 3119126300406
Fax
+98 31 1792 2934
Email
samereh_abvdoli@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ghasemipoor Mahboobeh
Position
Nurse, MS of Nursing
Other areas of specialty/work
Street address
Isfahan Nursing and Midwifery School
City
Isfahan
Postal code
Iran
Phone
+98 31 2527 4698
Fax
+98 31 1792 2934
Email
ghasemipoor@nm.mui.ac.irghasemipoormahboobeh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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