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IRCT20090810002324N19 IRCT 2022-05-10 Iran University of Medical Sciences The effect of two-different time methods of kangaroo care on anxiety, depression, and general health in mothers of premature infants. Comparison of two-different time methods of kangaroo care on anxiety, depression, and general health in mothers of premature infants discharged from the neonatal intensive care unit. 2022-05-19 anticipated 165 Complete https://irct.ir/trial/61164 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For one of the two interventions and the control group, will be assigned one of the codes A, B, and C. The allocation of the neonates to each group was randomly assigned by using six-block size. Participants will be placed in one of the two interventions or the control group based on the codes in one of the specified block. For concealment, each block will be placed in an opaque envelope. Each envelope will be randomly selected by a research assistant, Blinding description: Researcher will not be aware about the allocation of groups, also all questionnaires will be gathered by the research assistant who will be unaware of projects aims. N/A The mean score of anxiety, depression and general health. Intervention 1: Intervention group: The scheduled kangaroo care group. This care will be performed daily in three shifts: in the morning, afternoon, and evening, each time for 30 minutes. Mothers will be taught how to implement kangaroo care. The baby will be placed in a special kangaroo care cover, vertically between the mother's breasts. Skin-to-skin contact will be made, so the mother's chest will be contacted with the front of the baby's body, and turning the baby's head to the sideways. To maintain a body proper temperature may be used for baby a hat, socks or diaper. Intervention 2: Intervention group: The not scheduled kangaroo care group. This care will be performed at any time and according to the mother's desire. It will take at least 30 minutes for each skin-to-skin contact between the mother and baby. Mothers will be taught how to implement kangaroo care. The baby will be placed in a special kangaroo care cover, vertically between the mother's breasts. Skin-to-skin contact will be made, so the mother's chest will be contacted with the front of the baby's body, and turning the baby's head to the sideways. To maintain a body proper temperature may be used for baby a hat, socks or diaper. Intervention 3: Control group: Kangaroo care cover will not be used in this group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Decisions will be made in the future.
public Maryam Keshavarz
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St.
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1813 keshavarz.m@iums.ac.ir Iran University of Medical Sciences scientific Maryam Keshavarz
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St.
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1813 keshavarz.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iranian primiparous women, age 18-35 year. Wanted and single pregnancy. Gestational age of 32-37 Weeks for neonate. Apgar scores equal or greater than 7 In the 5th minute of neonate birth. 18 years 35 years Female Psychological disorders ( according to personal reporting ). Chronic disease of mother ( Diabetes / multiple sclerosis / Cardio - vascular disease ). Maternal addiction to cigarettes, alcohol and psychotropic substances ( according to personal reporting ). History of recurrent miscarriage, infertility or infertility treatment. Stressful experiences such as divorce or death of family members in past three months. Congenital anomalies of infants. Prevention Prevention N/A Intervention group: The scheduled kangaroo care group. This care will be performed daily in three shifts: in the morning, afternoon, and evening, each time for 30 minutes. Mothers will be taught how to implement kangaroo care. The baby will be placed in a special kangaroo care cover, vertically between the mother's breasts. Skin-to-skin contact will be made, so the mother's chest will be contacted with the front of the baby's body, and turning the baby's head to the sideways. To maintain a body proper temperature may be used for baby a hat, socks or diaper. Intervention group: The not scheduled kangaroo care group. This care will be performed at any time and according to the mother's desire. It will take at least 30 minutes for each skin-to-skin contact between the mother and baby. Mothers will be taught how to implement kangaroo care. The baby will be placed in a special kangaroo care cover, vertically between the mother's breasts. Skin-to-skin contact will be made, so the mother's chest will be contacted with the front of the baby's body, and turning the baby's head to the sideways. To maintain a body proper temperature may be used for baby a hat, socks or diaper. Control group: Kangaroo care cover will not be used in this group. The mean score of mother's anxiety. Timepoint: Before the intervention and after 1 month intervention. Method of measurement: The anxiety of Beck questionnaire. The mean score of mother's depression. Timepoint: Before the intervention and after 1 month intervention. Method of measurement: Postpartum Depression of Edinburgh Questionnaire. General Health. Timepoint: Before the intervention and after 1 month intervention. Method of measurement: General Health Questionnaire (GHQ). Depressed mood. Timepoint: Before the intervention and then after 1 month intervention. Method of measurement: Depressed mood in the Profile of Mood States Questionnaire (POMS) (McNair). Iran University of Medical Sciences Approved 2022-01-25 Ethics committee of Iran University of Medical sciences School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St. Tehran Tehran Iran (Islamic Republic of)