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IRCT20160119026104N6 IRCT 2019-09-22 Iran University of Medical Sciences The effect of mothers voice on Pain and physiological indicators during arterial blood sampling and in children hospitalized in pediatric intensive care unit the effect of mothers voice on arterial blood sampling on pain and physiological indicators in pediatrics hospitalized in pediatric intensive care unit 2019-01-28 anticipated 100 Complete https://irct.ir/trial/36501 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: The sampling will do in sequential method. random allocation will used with 2 blocking. The participants will be divided into two groups, Blinding description: Research assistance during the process of data gathering. will not know that The child listen to mother voice or not. Data will be sent in coding (A,B) for analysis. N/A Condition 1: Pain. Condition 2: Physiologic indicators. Intervention 1: Intervention group 1: Getting arterial blood sampling while the child listen to mother's voice and after at least 24 hours getting arterial blood sampling while the child don't listen to mother's voice. pain and physiologic indicators will be assessed before and during arterial blood sampling. Intervention 2: Intervention group B: Getting arterial blood sampling while the child don't listen to mother's voice. and after at least 24 hours getting arterial blood sampling while the child listen to mother's voice. pain and physiologic indicators will be assessed before and during arterial blood sampling. 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
Tehran, Valiasr Ave, above Vanak Square, Rashid Yasemi Ave., Iran Nursing Midwifery Faculty
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 shoghi.m@iums.ac.ir Iran University of Medical Sciences scientific Mahnaz Shoghi
Nursing and Midwifery School, 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) Have at least 9 alertness levels based on Glasgow scale No have hearing impairment No be under ventilation No take analgesic drugs at least three hours before sampling Lack of childhood developmental delay No have cognitive disorders No have Neuromuscular disorders, such as Guillain Barre and mental retardation 2 years 8 years Both Other Other Intervention group 1: Getting arterial blood sampling while the child listen to mother's voice and after at least 24 hours getting arterial blood sampling while the child don't listen to mother's voice. pain and physiologic indicators will be assessed before and during arterial blood sampling Intervention group B: Getting arterial blood sampling while the child don't listen to mother's voice. and after at least 24 hours getting arterial blood sampling while the child listen to mother's voice. pain and physiologic indicators will be assessed before and during arterial blood sampling Pain during arterial blood sampling. Timepoint: Before arterial blood sampling, during arterial blood sampling. Method of measurement: pain assessment comfort scale. Physiological indicators. Timepoint: Before arterial blood sampling, during arterial blood sampling. Method of measurement: Record from monitor. Iran University of Medical Sciences Approved 2018-12-23 Ethics committee of Iran University of Medical Sciences Tehran, Valiasr Ave., higher than Vanak Square, Rashidiassemi Avenue, Iran Nursing Midwifery Faculty Tehran Tehran Iran (Islamic Republic of)