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IRCT20260622069912N1 IRCT 2026-06-29 Shahid Beheshti University of Medical Sciences Comparison the effect of mother- delivered Stroking and Gentle Human Touch on Maternal Attachment behaviors, Vital Signs, and Comfort of Preterm Infants During Invasive Procedures gastric catheter insertion in the NICU Comparison the effect of mother- delivered Stroking and Gentle Human Touch on Maternal Attachment behaviors, Vital Signs, and Comfort of Preterm Infants During Invasive Procedures gastric catheter insertion in the NICU 2026-07-23 anticipated 90 Recruiting https://irct.ir/trial/91171 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Randomization description: Randomization will be performed using **Microsoft Excel** and its random number generation function. N/A Preterm Infants. Intervention 1: Control group: Routine care. Intervention 2: Intervention group: First, stroking (gentle stroking of the infant's body by the mother at a speed of 3 cm/s). Intervention 3: Intervention group: Second, gentle human touch (putting the mother's hands gently on the baby's head and belly without moving). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Seyede Razie Mirsadeghi
School of Nursing and Midwifery, Opposite Shahid Rajaei Heart Hospital, Valiasr St., Intersection of Ayatollah Hashemi Rafsanjani Expressway, Tehran, Iran
Teran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 razie.mirsadeghi@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyede Razie Mirsadeghi
No. 20, Jahandad Alley, East Akhlaghi St., Kolahdooz St., Shariati St
Tehran Iran (Islamic Republic of) 1939843938 +98 21 2263 2303 razie.mirsadeghi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Gestational age between 32 weeks and 36 weeks + 6 days Hemodynamic stability (confirmed by the attending physician) Full neonatal consciousness, as assessed by the nurse, with the ability to respond to painful stimuli No feeding within 1 hour prior to the intervention No administration of sedative or analgesic medications within 2 hours prior to the intervention No painful procedures performed within 30 minutes prior to the intervention The neonate is in a calm, awake state before the intervention begins Requirement for nasogastric (gastric) tube insertion No history of maternal substance abuse during pregnancy Written informed consent signed by the mother 224 days 258 days Both Neurological injury Brain injury secondary to asphyxia or hypoglycemia Inborn metabolic disorders Severe respiratory distress syndrome requiring endotracheal intubation Intraventricular hemorrhage (IVH) greater than Grade II Neonatal skin disease Deterioration of the neonate's clinical condition during the study Maternal skin lesions or inability to learn the intervention Parents' withdrawal of consent or decision to discontinue participation in the study Other Other Other Control group: Routine care Intervention group: First, stroking (gentle stroking of the infant's body by the mother at a speed of 3 cm/s) Intervention group: Second, gentle human touch (putting the mother's hands gently on the baby's head and belly without moving) Infant heart rate. Timepoint: 15 minutes before, immediately before, during, and 5 minutes after the procedure. Method of measurement: Infant heart monitor. Blood oxygen saturation. Timepoint: 15 minutes before, immediately before, during, and 5 minutes after the procedure. Method of measurement: Pulse oximeter percentage. Infant's blood pressure. Timepoint: 15 minutes before, immediately before, during, and 5 minutes after the procedure. Method of measurement: Blood pressure monitor. Infant's comfort. Timepoint: 15 minutes before the procedure and 5 minutes after the procedure. Method of measurement: COMFORT checklist. Mother's attachment. Timepoint: One hour to half an hour before the procedure and the next day. Method of measurement: Avant Checklist. Shahid Beheshti University of Medical Sciences Approved 2026-06-15 Ethics Committee in Research of the Faculties of Pharmacy, Nursing and Midwifery, Shahid Beheshti Un Tehran - Wali Asr Street - Niaish Intersection - Faculty of Nursing and Midwifery Tehran Tehran Iran (Islamic Republic of)