]>
IRCT20130617013691N11 IRCT 2020-01-21 Tabriz University of Medical Sciences Effect of Multisensory Stimulation care plan on pain of Retinopathy Effect of Multisensory Stimulation care plan on pain of Infants during Eye Examination for Retinopathy 2019-11-21 anticipated 50 Complete https://irct.ir/trial/43447 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: Using a checklist prepared using Randlist software, the first group will be assigned to the control group by drawing one of the letters a or b and the other letter by the intervention group. A and B are divided and placed in opaque envelopes by the research assistant (allocation concealment). Parents are asked to select one of the envelopes. N/A Condition 1: Retinopathy. Condition 2: Pain. Intervention 1: Intervention group:One hour before eye examination, 0.5% tetracaine drops will be given 3 times each time for 5 minutes.Then, 5 minutes before the examination, during the insertion of the speculum, and 5 minutes after the speculum is removed, the pain score and the physiological data of the infant will be recorded.After recording basic data,The researcher's help will try to keep one standard, small, short, full-length, one- six month-old baby pacifier in the infants mouth.(The same type pacifier will be used for all infants).This will continue during the examination.After removing the speculum from the eye which means that the examination is completed,The pacifier will come out of the baby's mouth.Simultaneously, foot massage will be performed slowly by the researcher 2 minutes before the eye examination.After removal of the spaculum, the foot massage will be discontinued immediately.One minute before inserting the spaculum, distracting through the sound of a toy,Shaken by the mother done.At the end of the examination, the rattle will also be muted. Intervention 2: Control group: One hour before eye examination, 0.5% tetracaine drops will be given 3 times each time for 5 minutes.Then, 5 minutes before the examination, during the insertion of the speculum, and 5 minutes after the speculum is removed, the pain score and the physiological data of the infant will be recorded.There is no intervention during the examination. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome, can be shared. When: Start of access period 6 months after printing results To whom: Researchers at academic and research institutes can apply for data if needed. Conditions: Use of this research data in similar research is permitted unless noted and copied. Where to obtain: Applicants can apply for documentation or data through the following Send message to email: saba.moghtader73@gmail.com Send message to email: Arshadi_m@yahoo.com Call the phone number: 09141392603 How to obtain: Seven days after receipt of the request the applicant will be provided with the documentation or data file. Comments:
public Mohamad Arshadi
Seyedoshohada Hospital, 17 Shahrivar Blvd, Urmia City
Tabriz Iran (Islamic Republic of) 5718748983 +98 44 3346 2362 saba.moghtader73@gmail.com Tabriz University of Medical Sciences scientific Mohamad Arshadi Bostanabad
School of Nursing, South Shariati St., Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5718748983 +98 41 3479 6770 Arshadi_m@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Infants with retinopathy 2-6 months old The infant is calm and awake Do not take painkillers or sadatives for the past 24 hours Mother of the baby to be present Parents of infants consent to participate in the study 2 months 6 months Both Do not attempt to insert the spaculum more than once There is no need for urgent resuscitation during the examination History of CPR, operation, Intraventricular hemorrage more than grade 2, Major infant birth defect such az cadiac and CNS disaeses Oral problems such as cleft palate and oral ulsers No abnormality in the leg area H36 R52 Retinal disorders in diseases classified elsewhere Pain, unspecified N/A N/A Intervention group:One hour before eye examination, 0.5% tetracaine drops will be given 3 times each time for 5 minutes.Then, 5 minutes before the examination, during the insertion of the speculum, and 5 minutes after the speculum is removed, the pain score and the physiological data of the infant will be recorded.After recording basic data,The researcher's help will try to keep one standard, small, short, full-length, one- six month-old baby pacifier in the infants mouth.(The same type pacifier will be used for all infants).This will continue during the examination.After removing the speculum from the eye which means that the examination is completed,The pacifier will come out of the baby's mouth.Simultaneously, foot massage will be performed slowly by the researcher 2 minutes before the eye examination.After removal of the spaculum, the foot massage will be discontinued immediately.One minute before inserting the spaculum, distracting through the sound of a toy,Shaken by the mother done.At the end of the examination, the rattle will also be muted. Control group: One hour before eye examination, 0.5% tetracaine drops will be given 3 times each time for 5 minutes.Then, 5 minutes before the examination, during the insertion of the speculum, and 5 minutes after the speculum is removed, the pain score and the physiological data of the infant will be recorded.There is no intervention during the examination. Pain score in Neonatal Infant Pain Scale. Timepoint: Five minutes before an eye examination/During the eye examination/Five minutes after doing eye examination. Method of measurement: Neonatal Infant Pain Scale. Tabriz University of Medical Sciences Approved 2019-10-27 Ethics committee of Tabriz University of Medical Sciences seyed o Shohada Hospital, 17 Shahrivar Blvd, urmia city Tabriz East Azarbaijan Iran (Islamic Republic of)