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IRCT20140924019277N3 IRCT 2022-01-17 Mazandaran University of Medical Sciences The effect of massage on the sleep status of infants and mothers Comparison of the effect of massage compared to regular bedtime routines on the sleep status of 15-20 day old infants and the quality of sleep of their mothers 2020-09-22 anticipated 140 Complete https://irct.ir/trial/47597 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Randomization description: The card drawing technique was used to randomize the assignment of subjects to the groups. A total of 140 identical cards were first prepared and 70s were labeled A (routine night time ), 70 B( newborn massage ). A card was randomly drawn for each participant who entered the study by an independent assistant researcher (engaged only in the randomization process) and the type of intervention written on the card was announced by another researcher, Blinding description: Randomization process and assessment of the form of maternal and infant sleep status is performed by the researcher without the knowledge of the allocation of groups. N/A infant sleep condition and mother sleep quality. Intervention 1: Intervention group :Massage the baby before going to bed every night for 2 weeks, 15 minutes each time, plus the usual bedtime interventions such as changing diapers and breastfeeding.Massaging the infant would be done in three 5-minute cycles. At first and to prevent skin friction, the mother would moisturize her hands with baby lotion and begin massaging according to the following procedures:1. In the first 5 minutes, the mother would lay the baby on the stomach, and the massage would begin by applying, in a pat-like manner, moderate pressure on the head, shoulders, back, arms, and legs (each part would be massaged for 6-10 seconds).2. In the second cycle, the baby would be laid on the back for 5 minutes, and the arms and legs would be first given ten extensions and flexions on their own, then both hands and feet.3. In the third 5 minutes, a massage would be given in similar conditions to the first 5 minutes. Intervention 2: Control group: Common bedtime interventions such as diaper changes and breastfeeding. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public sussan saatsaz
Faculty of Nursing and Midwifery of Amol,Mazandaran University of Medical Sciences, Sari, Iran
Amol Iran (Islamic Republic of) 579692442 +98 11 4422 1919 s.saatsaz@mazums.ac.ir Mazandaran University of Medical Sciences scientific sussan saatsaz
, Faculty of Nursing and Midwifery of Amol, Mazandaran University of Medical Sciences, Sari, Iran
sari Iran (Islamic Republic of) 0579692442 +98 11 4422 1919 s.saatsaz@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) all healthy newborn breastfeed exclusively singleton The first child weight 2500-4000 gr healthy mothers No postpartum depression Taking antidepressants 15 days 20 days Both Sick babies need treatment formula feeding anomali Other Other Intervention group :Massage the baby before going to bed every night for 2 weeks, 15 minutes each time, plus the usual bedtime interventions such as changing diapers and breastfeeding.Massaging the infant would be done in three 5-minute cycles. At first and to prevent skin friction, the mother would moisturize her hands with baby lotion and begin massaging according to the following procedures:1. In the first 5 minutes, the mother would lay the baby on the stomach, and the massage would begin by applying, in a pat-like manner, moderate pressure on the head, shoulders, back, arms, and legs (each part would be massaged for 6-10 seconds).2. In the second cycle, the baby would be laid on the back for 5 minutes, and the arms and legs would be first given ten extensions and flexions on their own, then both hands and feet.3. In the third 5 minutes, a massage would be given in similar conditions to the first 5 minutes. Control group: Common bedtime interventions such as diaper changes and breastfeeding Maternal sleep quality score. Timepoint: From 7 days before the intervention, the end of the first week and the end of the second week of the intervention. Method of measurement: The Pittsburgh sleep quality index. Infant sleep status markers. Timepoint: From 7 days before the intervention, the end of the first week and the end of the second week of the intervention. Method of measurement: The Brief Infant Sleep Questionnaire. Mazandaran University of Medical Sciences Approved 2019-06-12 Mazandran university of medical sciences Sari-serah joibar Sari Mazandaran Iran (Islamic Republic of)