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IRCT20160119026104N5 IRCT 2019-02-06 Iran University of Medical Sciences The effect of earmuffs and eye shields to pain response Effect of earmuffs and eye shields on pain in preterm infants during intravenous blood sampling in the neonatal intensive care unite 2018-11-21 anticipated 25 Complete https://irct.ir/trial/34546 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: First, we will randomize the allocation of treatments to the letters of the square. then we will design an arrangement of 4 letters in a 4 × 4 square array in such a way that each letter occurs once in each row and once in each column. For the Cyclic method, we will write the letters in the top row in alphabetical order. In the second row, shift the letters one place to the right. will Continue like this for other rows. N/A Condition 1: Pain. Condition 2: Premature infant. Intervention 1: Neonate Blood samples will be taken in 4-days with this sequence: ( A: Without eye shields and earmuff, B: With earmuff only, C: With eye Shields only, D : With eye shields and earmuff). Intervention 2: Neonate Blood samples will be taken in 4-days with this sequence: (B: With earmuff only, D: With eye shields and earmuff, A: Without eye shields and earmuff, C: With eye Shields only). Intervention 3: Neonate Blood samples will be taken in 4-days with this sequence: (C: With eye Shields only, A: Without eye shields and earmuff, D: With eye shields and earmuff, B: With earmuff only). Intervention 4: Neonate Blood samples will be taken in 4-days with this sequence: (D: With eye shields and earmuff, C: With eye Shields only, B: With earmuff only, A : A: Without eye shields and earmuff ). Yes - There is a plan to make this available What will be shared: After Data coding in order to keep the confidentiality of the participants in the research. When: The end of sampling till six months after article publishing. To whom: Ethical, Reviewer and Editorial committees, Researchers. Conditions: Systematic review and meta-analysis or secondary analysis citation . Where to obtain: Mahnaz Shoghi, Email: shoghi.m@iums.ac.ir How to obtain: After sending a request to academic email, we will send our data files up to one week. Comments:
public Mahnaz Shoghi
school of Nursing and Midwifery.,Shahid yasemi Street., North Kordestan highway., Tehran., Iran
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 shoghi.m@iums.ac.ir Iran University of Medical Sciences scientific Mahnaz Shoghi
school of Nursing and Midwifery.,Shahid yasemi Street., North Kordestan highway., Tehran., Iran
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 shoghi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Birth weight 1000 grams or more Apgar score above 6 at 5th minutes after birth. Not having painful procedures 4 hours before the intervention. Non-administration of sedative and muscle relaxants for the newborn. Clinical stability of the newborn. 203 days 259 days Both having respiratory assist device. Having chest tube. having Congenital anomalies and metabolic disorders. having intraventricular hemorrhage of grade 2 or more N/A N/A N/A N/A Neonate Blood samples will be taken in 4-days with this sequence: ( A: Without eye shields and earmuff, B: With earmuff only, C: With eye Shields only, D : With eye shields and earmuff). Neonate Blood samples will be taken in 4-days with this sequence: (B: With earmuff only, D: With eye shields and earmuff, A: Without eye shields and earmuff, C: With eye Shields only) Neonate Blood samples will be taken in 4-days with this sequence: (C: With eye Shields only, A: Without eye shields and earmuff, D: With eye shields and earmuff, B: With earmuff only). Neonate Blood samples will be taken in 4-days with this sequence: (D: With eye shields and earmuff, C: With eye Shields only, B: With earmuff only, A : A: Without eye shields and earmuff ) Pain during intravenous blood sampling. Timepoint: Before Intravenous blood sampling; During Intravenous blood sampling; After Intravenous blood sampling. Method of measurement: Premature Infant Pain Profile Scale. Iran University of Medical Sciences Approved 2017-08-08 Ethics committee of IRAN University of Medical Sciences school of Nursing and Midwifery.,Shahid yasemi Street., North Kordestan highway., Tehran., Iran Tehran Tehran Iran (Islamic Republic of)