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IRCT20160119026104N12 IRCT 2023-10-21 Iran University of Medical Sciences Comparison effect of lullabies, Nurture voice and white voice on pain of during insert IV line in premature infants in neonatal intensive care unit. Comparison effect of lullabies, Nurture voice and white voice on pain of during insert IV line in premature infants in neonatal intensive care unit 2023-08-23 anticipated 96 Complete https://irct.ir/trial/72121 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Make four blocks A-B-C-D by drawing a card by the first mother. In each card, different states of the block are specified and the researcher will place 4 babies in the specified group respectively. The above card is taken out of the pocket and the mother of the 5th baby again takes out a card from the envelope and the status of the next group of 4 babies will be determined. N/A Pain during IV line insertion. Intervention 1: Intervention group: listening to lullabies-lullabies will be played using an MP3 player and two tiny microphones placed on both sides of the baby's head at 20 cm. The sound broadcast in this intervention group started when the baby was transferred to the cut room and the baby's condition stabilized (about 5 minutes), and it will continue for 5 minutes after the end of the intervention. Intervention 2: Intervention group sound of nature- It will be played using an MP3 player and two tiny microphones placed on both sides of the baby's head at 20 cm. The sound broadcast in this intervention group started when the baby was transferred to the cut room and the baby's condition stabilized (about 5 minutes), and it will continue for 5 minutes after the end of the intervention. Intervention 3: Intervention group 3: the Wight Voice- It will be played using an MP3 player and two tiny microphones placed on both sides of the baby's head at 20 cm. The sound broadcast in this intervention group started when the baby was transferred to the cut room and the baby's condition stabilized (about 5 minutes), and it will continue for 5 minutes after the end of the intervention. Intervention 4: Control group: In the control group, the intravenous line was inserted according to the usual routine without any additional intervention, only based on the usual care in the ward, and the pain of the baby will be recorded using the same tools at the same times as the other three groups (5 minutes before, during and 5 minutes after). 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 the 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 the academic email, we will send our data files for up to one week. Comments:
public Mahnaz Shoghi
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
Tehran Iran (Islamic Republic of) 1996713883 0098214351000 shoghimmahnaz@yahoo.com 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) ۱۹۹۶۷۱۳۸۸۳ +98 21 4365 1000 shoghimmahnaz@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Not receiving sedatives during intravenous line insertion and at least 3 hours before that Apgar above five in the fifth minute after birth Birth weight equal or more than 1000 gr 28 days 32 days Both Diagnosis of hearing impairment (screening test confirmation) The presence of an underlying disease and extensive surgeries that cause pain (such as abdominal surgeries, etc.) Paralyzing diseases and anatomical defects of the limbs (hands and feet) R52.0 R52.0 N/A N/A N/A N/A Intervention group: listening to lullabies-lullabies will be played using an MP3 player and two tiny microphones placed on both sides of the baby's head at 20 cm. The sound broadcast in this intervention group started when the baby was transferred to the cut room and the baby's condition stabilized (about 5 minutes), and it will continue for 5 minutes after the end of the intervention. Intervention group sound of nature- It will be played using an MP3 player and two tiny microphones placed on both sides of the baby's head at 20 cm. The sound broadcast in this intervention group started when the baby was transferred to the cut room and the baby's condition stabilized (about 5 minutes), and it will continue for 5 minutes after the end of the intervention. Intervention group 3: the Wight Voice- It will be played using an MP3 player and two tiny microphones placed on both sides of the baby's head at 20 cm. The sound broadcast in this intervention group started when the baby was transferred to the cut room and the baby's condition stabilized (about 5 minutes), and it will continue for 5 minutes after the end of the intervention. Control group: In the control group, the intravenous line was inserted according to the usual routine without any additional intervention, only based on the usual care in the ward, and the pain of the baby will be recorded using the same tools at the same times as the other three groups (5 minutes before, during and 5 minutes after). Pain. Timepoint: Before inserting the IV line, during and 5 minutes after the completion of the inserting the IV line. Method of measurement: Neonatal Infant Pain Scale. Iran University of Medical Sciences Approved 2023-11-01 کمیته اخلاق دانشگاه علوم پزشکی ایران Tehran, Valiasr Ave., higher than Vanak Square, Rashidiassemi Avenue, Iran Nursing Midwifery Faculty Tehran Tehran Iran (Islamic Republic of)