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The effect of relaxation on fasting blood glucose and blood pressure in women with gestational diabetes mellitus

Protocol summary

Summary
Main goal: determining the effects of relaxation on the fast blood sugar, systole and diastole blood pressure among women with pregnancy diabetes Design of study conduction: non-randomized, not blinding, single- centered, with control group Way of performing: the intervention group will be offered a training session for relaxation for 45 minutes. They will receive a manual book of relaxation method with a CD and a checklist of activities. Criteria of inclusion: diagnosis of pregnancy diabetes by specialist physician; gestational age more than 24 weeks and lower than 26 weeks, without illnesses such as asthma, chronic hypertension, epilepsy and etc, lack of taking special drugs of pregnancy Criteria of exclusion:excessive stress, the risk of pregnancy complications such as preeclampsia,the necessity of performing other psychiatric intervention, using sedative and antianxiety, initiating insulin shot Study population: 80 individuals Body mind and mind body as studied intervention: relaxation technic Intervention term: 10 weeks Studied consequences: fast blood sugar (gr/dL). systole and diastole blood) Millimeters of mercury( Control group: this group will obtain routine clinical health care. Intervention group: In technic classes the relaxation will be trained by the researcher in the form of role paly and CD play .The mother is asked in this method to lie and close eyes in the best position. In this position bringing her relaxation and initiates to breath deeply and regularly relaxes here muscles . they will receive a manual and CD of relaxation and a checklist for practice exercises.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015071222943N2
Registration date: 2015-12-31, 1394/10/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-31, 1394/10/10
Registrant information
Name
Sara Bikdelo
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
sbigdelo@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Tehran University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of relaxation on fasting blood glucose and blood pressure in women with gestational diabetes mellitus
Public title
The effect of relaxation on fasting blood glucose and blood pressure in women with gestational diabetes mellitus
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria of inclusion in the study: diagnosis of pregnancy diabetes by specialist physician; gestational age more than 24 weeks and lower than 26 weeks, lack of identified mental disorders, without illnesses such as asthma, chronic hypertension, kidney, heart, epilepsy which affects the blood sugar and pressure, lack of taking special drugs of pregnancy which affects blood sugar and pressure, ability to understand and speak Persian, literacy read and write; no history of stillbirth and infertility. Criteria of exclusion from the study: missing pregnancy, excessive stress such as the death of someone close, intense family conflicts, accident and surgery operation during the research, nor performing relaxation exercises more than three consecutive days and lack of desire to cooperate, the risk of pregnancy complications such as preeclampsia, bleeding during the third trimester of pregnancy and infection during pregnancy, the necessity of performing other psychiatric intervention including necessity of visiting a psychiatrist, using sedative and antianxiety and doing hypnotism during research, initiating insulin shot during current pregnancy.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Since sampling has been performed just in Imam Khomeini Hospital and was single- centered and for avoiding conflict of samples of control and intervention groups, we first will perform sampling in control group followed by the intervention group.

Secondary Ids

1

Registry name
.
Secondary trial Id
.
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
The Street Qhods, Blvd Keshavarz, Tehran. Tehran University of Medical Sciences
City
Tehran
Postal code
1419733171
Approval date
2015-05-26, 1394/03/05
Ethics committee reference number
IR.TUMS.REC.1394.9111373010-145793

Health conditions studied

1

Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in Pregnancy

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
fast blood sugar (gr/dL) which will be measured prior to the intervention and after the intervention session will be finished through a laboratory method
Method of measurement
laboratory method and In gram per dc litr

2

Description
Systolic and diastolic blood pressure
Timepoint
systole and diastole blood pressure will be measured prior to the intervention and after the intervention session will be finished by a mercury sphygmomanometer
Method of measurement
mercury sphygmomanometer and Millimeters of mercury and

Secondary outcomes

1

Description
.
Timepoint
.
Method of measurement
.

Intervention groups

1

Description
Control group: first, we will take samples of systole and diastole blood pressure and blood sugar for women with pregnancy diabetes and during study period this group will obtain routine clinical health care. In the end of the study, they will receive a CD and a manual of relaxation
Category
Other

2

Description
Intervention group: this group will take a session for 45 minute training relaxation and they will attend relaxation class next sessions. There are 1-4 attendant each session. In technic classes the relaxation will be trained by the researcher in the form of role paly and CD play and the mod is from mind-body and body mind type. The mother is asked in this method to lie and close eyes in the best position. In this position, she selects a word (such as Good, Love and etc.) bringing her relaxation and initiates to breath deeply and regularly such that inhales through nose and exhale from the mouth and repeats the word and in the same time relaxes here muscles starting from toes’ tip toward upper muscles until all muscle to be fully expanded and keep this state 20 minutes and then opens her eyes. Then, all subjects are asked to practice the technic to obtain enough skill. After the technic is being thought, they are asked to act this technic twice a day at home and they will receive a manual and CD of relaxation and a checklist for practice exercises. The term of this technic is 10 weeks and the subjects will be contacted through telephone once a week.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Sara Bikdeloo
Street address
End Of keshavarz BLvd, Tehran, Imam khomeini hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Tehran University of Medical Sciences
Full name of responsible person
Research assistant Tehran University of Medical Sciences
Street address
The Street Qhods, Blvd Keshavarz, Tehran. Tehran University of Medical Sciences
City
Tehran
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 Tehran 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
Tehran School of Nursing and Midwifery
Full name of responsible person
Sara Bikdeloo
Position
Master degree midwifery student
Other areas of specialty/work
Street address
Street Nosrat Eastern(Avenue Doctor Myrkhany), Tohid Square, Tehran School of Nursing and Midwifery
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
bigdelys@gmail.com؛ sbigdelo@razi.tums.ac.ir
Web page address
http://fnm.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran School of Nursing and Midwifery
Full name of responsible person
Mehrnaz Geranmaye
Position
Department of faculty members
Other areas of specialty/work
Street address
Street Nosrat Eastern (Avenue doctor Myrkhany)، Tohid Square,Tehran
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
Geranmay@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran School of Nursing and Midwifery
Full name of responsible person
Sara Bikdeloo
Position
Masrer degree midwifery student
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 5633 3511
Fax
Email
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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