Objective: Comparison the effect of short massage system with routine education on self-care of pregnant prediabetic women.
Design: Parallel randomized clinical trial
Randomization: Patients will allocate to two equal groups of routine and short massage system educations according to table of random numbers.
Participants including major eligibility criteria: this study will conduct on 100 patients with prediabes in Ahvaz Imam Khomeini and Gholestan hospitals. Main inclusion criteria include pregnant women in 12-24 weeks of pregnancy which like to participate in the study; having fasting blood glucose 93-125 mg/dl in blood sugar test; lack of observing any specific diet or lack of any specific kind of exercises; ability to response to questions and participate in educational sessions and main exclusion criteria include having any diseases which interfere with study protocol such as mental diseases, myocardial infarction, stroke or drug abuse; lack of participating in educational sessions more than 2 times; lack of responding to short massage systems with a blank text in 2 days.
Main outcome: Self-care
Intervention: Subjects in control group will receive education through lecture method in 5 sessions during 10 weeks consecutively in recruitment centers. Subjects in intervention group will receive 2 short massage systems every other day during 10 weeks consecutively beside routine education.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112531082N1
Registration date:2016-12-13, 1395/09/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-13, 1395/09/23
Registrant information
Name
Anis Amani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 0673
Email address
abbaspoor-z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences
Expected recruitment start date
2016-10-09, 1395/07/18
Expected recruitment end date
2017-03-02, 1395/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of short massage system on self care of pregnant prediabetic women
Public title
Comparison the effect of short massage system with routine education on self care of pregnant prediabetic women refereed to Ahvaz health centers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women in 12-24 weeks of pregnancy which like to participate in the study; having fasting blood glucose 93-125 mg/dl in blood sugar test; lack of observing any specific diet or lack of any specific kind of exercises; ability to response to questions and participate in educational sessions. Exclusion criteria: having any diseases which interfere with study protocol such as mental diseases, myocardial infarction, stroke or drug abuse; lack of participating in educational sessions more than 2 times; lack of responding to short massage systems with a blank text in 2 days.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan
City
Ahvaz
Postal code
Approval date
2016-10-08, 1395/07/17
Ethics committee reference number
IR.AJUMS.REC.1395.440
Health conditions studied
1
Description of health condition studied
Prediabetes
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test
Primary outcomes
1
Description
Self-care
Timepoint
before and after intervention (in 24 weeks of pregnancy)
Method of measurement
Researcher-made questionnaire
Secondary outcomes
1
Description
Diet
Timepoint
Before and after intervention (in 24 weeks of pregnancy)
Method of measurement
Food frequency questionnaire
2
Description
Exercise
Timepoint
Before and after intervention (in 24 weeks of pregnancy)
Method of measurement
International physical activity questionnaire- short form
Intervention groups
1
Description
Subjects in control group will receive education through lecture method in 5 sessions during 10 weeks consecutively in recruitment centers.
Category
Prevention
2
Description
Subjects in intervention group will receive 2 short massage systems every other day during 10 weeks consecutively beside routine education.