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IRCT20230202057303N1 IRCT 2023-04-06 Iran University of Medical Sciences Comparative of the Effect of Gentle Human Touch Versus Sucrose on Orogastric Tube Insertion Pain and Distress in Preterm Infant Admitted to Neonatal Intensive Care Units: A randomized clinical trial Comparative of the Effect of Gentle Human Touch Versus Sucrose on Orogastric Tube Insertion Pain and Distress in Preterm Infant Admitted to Neonatal Intensive Care Units: A randomized clinical trial 2023-02-20 anticipated 40 Complete https://irct.ir/trial/68413 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: According to the design of this randomized clinical trial study (crossover design), the selected infants will be placed once in the control condition and twice in the intervention conditions (gentle human touch intervention and sucrose intake intervention). The order of placing the nasogastric tube in the usual way and receiving interventions in each baby will be randomly determined. which will be assigned to the desired groups using computer randomization (www.randomizer.org), in such a way that the sequence of placement in the control and intervention conditions will be done randomly. Allocation information will only be available to a researcher. N/A Condition 1: pain. Condition 2: distress. Intervention group: gentle human touch, oral sucrose. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mona Alinejad Naene
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 4365 1180 mona_alinejad@yahoo.com Iran University of Medical Sciences scientific Mona Alinejad Naeine
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 4365 1180 mona_alinejad@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Gestational age between 29-36 weeks Corrected Age after birth 3 to 28 days Birth weight 3000-1200 grams Instructions for feeding with an oral-gastric tube 29 days 36 days Both Receiving sedatives or anesthetics and muscle relaxants Receive any painkillers in prescription medications Having a skin disease Exposure to any painful procedure at least one hour before intubation Congenital anomalies Metabolic diseases Grade 2 and higher intracranial hemorrhage Cardiac abnormalities History of drug abuse by mother Convulsions G89.11 F45.4 Acute pain due to trauma The predominant complaint is of persistent, severe, and distressing pain, which cannot be explained fully by a physiological process or a physical disorder, and which occurs in association with emotional conflict or psychosocial problems that are sufficie N/A Intervention group: gentle human touch, oral sucrose Pain, Distress. Timepoint: 3 days in a row. Method of measurement: The Premature Infant Pain Profile: Revised- Comfort neo scale. iran university of medical sciences Approved 2023-01-01 Research Ethics Committee's Iran university of medical sciences School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)