The effect of relaxation on blood sugar and blood pressure in pregnant women with gestational diabetes mellitus,referring to selective centers of Shiraz University of Medical Sciences- 1392
The purpose of the study and study design:to survey the effect of relaxation on blood glucose and blood pressure changes in pregnant women with gestational diabetes- Random -not blinded- placebo not used- The study population: Volunteers who aged between 18 to 40 years and eligible for inclusion. Inclusion criteria: having gestational diabetes not overt diabetes; Gestational diabetes diagnosed by a gynecologist; being literate; age between 18 to 40 years; having ability to understand Persian language; living in Fars province; having ability to participate in educational programs, follow-up and implementation of the training program; gestational age between 24 to 30 weeks; no previous training about the subject; no severe mental illness and insanity. exclusion criteria: lack of willingness to continue in every phase of the study; refusing to participate in more than one session of training classes; not performing more than five days of relaxation at home; and the women who experience complication of pregnancy during the study. Sample: 8 eligible participants was selected from the population and randomly divided into two equal groups of 29 (Relaxation training group and the control group) Intervention: Educational Relaxation sessions (five sessions over three weeks) in training group - control group (not intervention)-Completion of the questionnaires: beginning of the intervention and Completion the experiment results prior to the intervention, immediately after intervention and one month after intervention in both groups. Study Outcome: the effect of Relaxation on four variables (Fasting plasma glucose, 2-hour postprandial blood glucose, systolic and diastolic blood pressure) in pregnant women with gestational diabetes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091014612N1
Registration date:2013-11-21, 1392/08/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-21, 1392/08/30
Registrant information
Name
Niloofar Bahoosh
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 8872
Email address
bahoosh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Sciences
Expected recruitment start date
2013-05-20, 1392/02/30
Expected recruitment end date
2013-08-21, 1392/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of relaxation on blood sugar and blood pressure in pregnant women with gestational diabetes mellitus,referring to selective centers of Shiraz University of Medical Sciences- 1392
Public title
The effect of relaxation on blood glucose and blood pressure changes in pregnant women with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having gestational diabetes not overt diabetes; Gestational diabetes diagnosed by a gynecologist; being literate; age between 18 to 40 years; having ability to understand Persian language; living in Fars province; having ability to participate in educational programs, follow-up and implementation of the training program; gestational age between 24 to 30 weeks; no previous training about the subject; no severe mental illness and insanity. exclusion criteria: lack of willingness to continue in every phase of the study; refusing to participate in more than one session of training classes; not performing more than five days of relaxation at home; and the women who experience complication of pregnancy during the study.
Age
From 19 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
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
Shiraz University Of Medical Sciences
Street address
Shiraz, Zand Ave, Shiraz University Of Medical Science Building
City
Shiraz
Postal code
7193613119
Approval date
2013-07-16, 1392/04/25
Ethics committee reference number
CT-92-6614
Health conditions studied
1
Description of health condition studied
gestitinal diabetes mellitus
ICD-10 code
o24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
fasting blood sugar
Timepoint
Prior to the intervention, immediately after intervention and one month after the intervention
Method of measurement
Blood tests
2
Description
2-hour postprandial blood glucose
Timepoint
Prior to the intervention, immediately after intervention and one month after the intervention
Method of measurement
Blood tests
Secondary outcomes
empty
Intervention groups
1
Description
intervention groups: Relaxation Training session for 5 sessions 45 minute over3 weeks and Relaxation at home ,daily within 1 month
Category
Treatment - Other
2
Description
control group:with out intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Niloofar Bahoosh Student, MSc in Midwifery
Street address
Abiverdi streetو Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Shiraz University Of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Hatam
Street address
7th Flat, Central department of Shiraz University Of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
ct-92-6614
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Shiraz 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
Fatemeh (PBUH) College of Nursing and Midwifery
Full name of responsible person
Maasumeh kaviani
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 1647 4258
Fax
+98 71 1647 4254
Email
kavianimaasumeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh College of Nursing And Midwifery
Full name of responsible person
Maasume kaviani
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 1647 4258
Fax
+98 71 1647 4254
Email
kavianimaasumeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh College of Nursing And Midwifery
Full name of responsible person
Niloofar Bahoosh
Position
Student, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Postal code
7188978185
Phone
+98 71 1623 8872
Fax
Email
bahooshn@yahoo.combahooshn@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)