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IRCT2017013032307N1 IRCT 2017-11-19 Vice Chancellor for Research Kerman University of Medical Sciences The effect of kangaroo mother care on maternal fatigue Investigating the effect of Kangaroo mother care on maternal fatigue of premature infant hospitalized in Neonatal Intensive Care Unit (NICU) 2016-07-22 anticipated 100 Complete https://irct.ir/trial/25208 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: To allocat randomly the participants in two groups with 50 people in each group, permuted block randomizaton method will be used. so that 25 blocks of 4 are used. In this method, the control and intervention groups are divided into two groups A and B. The possible blocks are AABB, ABAB, BAAB, BBAA, ABBA, BABA, and they numberd from 1 to 6 respectively. Then it is extracted from the random numbers table of numbers from 1 to 6. Obviously, in the case of extraction of the zero number and the number 7 to 9 is again taken from the random number table. A block is selected proportional to the number of extracted from random number table, so that 25 blocks are specified. In the sequel, a list of 100 participants will be provided as the 25 blocks will be specified and the participant will be allocated to groups A and B in the same order as the blocks are obtained. N/A Fatigue. Intervention 1: In intervention group, kangaroo mother care will be performed for 60 minutes in a manner of which the mother, wearing sleeveless, front open gown, will sit on a chair in a comfortable position with an angel of 45 to 60 degrees; then the investigator places the infant, who has been removed from the incubator, under the gown at the mother’s cleavage in an upright, chest to chest position.To keep the infant's airway open, their head will be tilted to one side and their neck will slightly be extended. The arms and legs should be flexed in a “frog” position. The baby, naked except the diaper, a warm hat and socks, will be carried in a kangaroo position secured with a binder. During the whole period of the intervention, the investigator will accompany the mother. Intervention will be done twice a day in late morning and evening shifts, as the ward is less crowded, for one week. Intervention 2: In the control group there is no intervention and the control group will receive routine care.
public Maryam Khajouei
Faculty of Razi Nursing and Midwifery, Kerman University of Medical Science, Blvd. Haftbagh Alavi
Kerman Iran (Islamic Republic of) +98 34 3132 5177 nmf@kmu.ac.ir; khajoueim1@mums.ac.ir; khajouei.maryam@yahoo.com Faculty of Razi Nursing and Midwifery, Kerman University of Medical Sciences scientific Farokh Abazari
Faculty of Razi Nursing and Midwifery, Kerman University of Medical Sciences, Blvd. Haftbagh Alavi
Kerman Iran (Islamic Republic of) +98 34 3132 5288 f_abazari@kmu.ac.ir Faculty of Razi Nursing and Midwifery, Kerman University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: primiparous mothers; mothers with the minimum age of 20 and maximums age of 35 years old; mothers with minimum literacy; mothers who their premature infants are hospitalized in NICU and those who breastfeed; the infants who are hospitalized for at least one week; infants must have the gestational age of 28- 34 weeks; single infant; infants without the use of mechanical ventilation and Birth weight>1200 gr and<2000 gr. exclusion criteria: incurable mother's diseases (physically or mentally); infants with anomaly; unwillingness of mothers to participate in the trial. 20 years 35 years Female F48.8 Other specified neurotic disorders Other N/A In intervention group, kangaroo mother care will be performed for 60 minutes in a manner of which the mother, wearing sleeveless, front open gown, will sit on a chair in a comfortable position with an angel of 45 to 60 degrees; then the investigator places the infant, who has been removed from the incubator, under the gown at the mother’s cleavage in an upright, chest to chest position.To keep the infant's airway open, their head will be tilted to one side and their neck will slightly be extended. The arms and legs should be flexed in a “frog” position. The baby, naked except the diaper, a warm hat and socks, will be carried in a kangaroo position secured with a binder. During the whole period of the intervention, the investigator will accompany the mother. Intervention will be done twice a day in late morning and evening shifts, as the ward is less crowded, for one week. In the control group there is no intervention and the control group will receive routine care. Fatigue. Timepoint: Pre and post intervention (before the intervention and one week after the intervention). Method of measurement: Visual analoge scale (VAS-F). Depression. Timepoint: Pre and post intervention (before intervention and one week after intervention). Method of measurement: Edinburgh Postnatal Depression Scale (EPDS). Vice Chancellor for Research Kerman University of Medical Sciences Approved 2017-01-25 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Blvd. Haftbagh Alavi, Kerman Kerman Iran (Islamic Republic of)