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IRCT2015071222943N2 IRCT 2015-12-31 Vice chancellor for research Tehran University of Medical Sciences The effect of relaxation on fasting blood glucose and blood pressure in women with gestational diabetes mellitus The effect of relaxation on fasting blood glucose and blood pressure in women with gestational diabetes mellitus 2015-07-23 anticipated 80 Complete https://irct.ir/trial/19679 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. 2 Gestational diabetes mellitus. Intervention 1: 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. Intervention 2: 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.
public Sara Bikdeloo
Street Nosrat Eastern(Avenue Doctor Myrkhany), Tohid Square, Tehran School of Nursing and Midwifery
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 bigdelys@gmail.com؛ sbigdelo@razi.tums.ac.ir Tehran School of Nursing and Midwifery scientific Mehrnaz Geranmaye
Street Nosrat Eastern (Avenue doctor Myrkhany)، Tohid Square,Tehran
Tehran Iran (Islamic Republic of) +98 21 6693 7120 Geranmay@sina.tums.ac.ir Tehran School of Nursing and Midwifery Iran (Islamic Republic of) 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. 15 years 45 years Female O24.4 Diabetes mellitus arising in Pregnancy Other Treatment - Other 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 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. 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. 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. . Timepoint: . Method of measurement: . . . Vice chancellor for research Tehran University of Medical Sciences Approved 2015-05-26 Ethics Committee of Tehran University of Medical Sciences The Street Qhods, Blvd Keshavarz, Tehran. Tehran University of Medical Sciences Tehran Iran (Islamic Republic of)