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IRCT20180310039023N1 IRCT 2020-01-08 Yazd University of Medical Sciences Investigating the effect of multisensory stimulation and breast milk on intensity of pain In premature infants in examination retinopathy Investigating the effect of multisensory stimulation and breast milk on intensity of pain In premature infants during examination for retinopathy screening 2018-05-22 anticipated 90 Complete https://irct.ir/trial/30198 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible infants are selected by Purpose-based sampling, and then assigned to one of three study groups by drawing method. The person who is unaware of the study will pick up one of the three numbers 1, 2 and 3 from the envelope, Blinding description: For the purpose of a single-blind study, individuals who are tasked with recording heart rate, oxygen saturation, and changes in face and behavior are blinded to the groups. N/A Pain Of Examination For Retinopathy. Intervention 1: In the intervention group, after stabilization of infant’s condition,the intervention including a multi sensory stimulation program (visual, taste, tactile, and smell stimulation)will be performed. At first, the infant is placed at supine position,and the hands and legs are bent as the fetal position,so that the infant could move freely.For tactile stimulation, face, upper and lower limbs of infant is gently touched by the mother. The intervention is performed from 15 minutes before the beginning examination until the time of examination .For visual stimulation, the infant’s mother will be asked to look at her baby from near and try for eye communication in order to attract the infant’s attention. The intervention is performed from 15 minutes before the beginning examination until the time of examination .For hearing stimulation, the infant’s mother will be asked to speak with her baby gently and continuously. The intervention is performed from 15 minutes before the beginning of examination until the time of examination . lavender essential oil 2% is used for smell stimulation. The researcher stains a piece of sterile gauze with 5 drops of it and clamps into the infant dress .. The intervention will be performed from 15 minutes before the beginning of examination until the time of examination.1 ml of 33% glucose solution will be used for taste stimulation. glucose solution will be drawn into a syringe by the researcher. The syringe mouth without needle will be placed into the infant’s mouth and the solution will be injected into the infant’s mouth with gentle movements along with infant’s sucking for 30 seconds. This intervention starts 2 minutes before the examination. The mother will be instructed by the researcher before the intervention is performed. The procedure will be followed in a coordinated and similar manner, so that all mothers will do the same. Intervention 2: Intervention group(breast milk) : 2 ml of breast milk is drawn by the researcher into the syringe in 2 minutes before examination and poured into the baby's mouth gently for 30 seconds. Intervention 3: Control group: The control group will receive no intervention, and routine care, including incubation and Nidcap care( neonatal individualized developmental care assessment plan), will be performed by mothers and staff on a regular and unplanned basis. 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 After the study is completed, it will be decided
public Khadije Dehghani
Bou Ali
Yazd Iran (Islamic Republic of) 8916978477 +98 35 3824 1751 dehghanish@ssu.ac.ir Yazd University of Medical Sciences scientific Khadije Dehghani
Bu Ali
Yazd Iran (Islamic Republic of) 8916978477 +98 35 3824 1751 dehghanish@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Premature neonates born with a fetal age of 32 weeks and 6 days or less, or weighing 1,500 grams or less, or babies weighing between 1500 and 2000 grams, accompanied by a period of unstable clinical conditions that lasted 4 weeks after birth The baby is checked for the first time The baby is fed one hour before the examination and no longer fed The baby looks calm and alert. Parents' written and informed consent to study agreement of the doctor who do examine no limit 1 year Both The baby has a history of surgery and cardiopulmonary resuscitation, and lung hemorrhage Apgar 5 minutes less than 6 Painkillers have been prescribed for the baby for the past 24 hours The baby needs to have a positive pressure and tracheal tube ventilation The baby has abnormalities and problems with the nervous system, heart and respiratory system Babies who should not be fed(n.p.o) H35.1 Retinopathy of prematurity Other Other Other In the intervention group, after stabilization of infant’s condition,the intervention including a multi sensory stimulation program (visual, taste, tactile, and smell stimulation)will be performed. At first, the infant is placed at supine position,and the hands and legs are bent as the fetal position,so that the infant could move freely.For tactile stimulation, face, upper and lower limbs of infant is gently touched by the mother. The intervention is performed from 15 minutes before the beginning examination until the time of examination .For visual stimulation, the infant’s mother will be asked to look at her baby from near and try for eye communication in order to attract the infant’s attention. The intervention is performed from 15 minutes before the beginning examination until the time of examination .For hearing stimulation, the infant’s mother will be asked to speak with her baby gently and continuously. The intervention is performed from 15 minutes before the beginning of examination until the time of examination . lavender essential oil 2% is used for smell stimulation. The researcher stains a piece of sterile gauze with 5 drops of it and clamps into the infant dress .. The intervention will be performed from 15 minutes before the beginning of examination until the time of examination.1 ml of 33% glucose solution will be used for taste stimulation. glucose solution will be drawn into a syringe by the researcher. The syringe mouth without needle will be placed into the infant’s mouth and the solution will be injected into the infant’s mouth with gentle movements along with infant’s sucking for 30 seconds. This intervention starts 2 minutes before the examination. The mother will be instructed by the researcher before the intervention is performed. The procedure will be followed in a coordinated and similar manner, so that all mothers will do the same. Intervention group(breast milk) : 2 ml of breast milk is drawn by the researcher into the syringe in 2 minutes before examination and poured into the baby's mouth gently for 30 seconds. Control group: The control group will receive no intervention, and routine care, including incubation and Nidcap care( neonatal individualized developmental care assessment plan), will be performed by mothers and staff on a regular and unplanned basis. Intensity Of Pain. Timepoint: During Eye Examination For Retinopathy. Method of measurement: PIPP Tool. Yazd University of Medical Sciences Approved 2018-05-16 National Ethics Committee for Biomedical Research Shahid Sadughi Yazd Yazd Iran (Islamic Republic of)