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IRCT20141216020344N4 IRCT 2021-03-10 Iran University of Medical Sciences Investigating the effect of maternal body massage on infant pain due to invasive procedures in premature infants, neonatal intensive care unit نوزادان نارس Investigating the effect of maternal body massage on infant pain due to invasive procedures in premature infants, neonatal intensive care unit 2021-03-21 anticipated 42 Complete https://irct.ir/trial/54339 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling method will initially be done randomly using the table of random numbers in the statistical reference book. The first choice from the table of even random numbers will be the sampling of the control group. Sampling in the control and test groups will be done by systematic randomization; In this way, according to the time specified in Jules Gantt for sampling, which is estimated to be 90 days (3 months), and also after reviewing and calculating the approximate number of admissions in the hospital, the number of samples that the conditions and The inclusion criteria for the present study are estimated to be one infant per day (approximately 90 eligible infants will be admitted to the hospital within 90 days). To get 21 samples in each group, divide 90 by 21 and it is approximately equal to 4. In this way, from the day of sampling, the first, fourth, eighth, twelfth and .... (multiple of 4) who are admitted to the hospital will be selected for sampling to achieve the required number of samples. (These numbers will be observed in sampling of both control and test groups. N/A premature infants. Intervention 1: Intervention group: In the intervention group, a booklet with an educational CD about massage training prepared by the Department of Neonatal Health is given to mothers. (Massage from head to toe while the baby's body is uncovered or only has diapers). Massage training video for mothers is shown by the researcher. Massage training classes are held in the conference hall of the hospital. All health protocols are observed. Before rushing to class, their vital signs are checked and they are asked about the history of contact with a person with coronary artery, and gloves and masks are provided to them, and the class is performed individually. The training sessions are performed in 2 one-hour sessions. The mothers practiced the massage on the model in the presence of the researcher, through face-to-face training, if the mother needed more sessions and hours to train. It will continue until he learns to massage properly. Proper performance of massage The fact that all mothers have a correct understanding of massage training is controlled by the researcher by observing the massage performed by mothers on the replica. In all stages of film distribution to teach massage, and practical massage practice, the researcher will be present to provide more explanations and solve the problems and questions of mothers. The first massage of the baby was done by the mother, with the presence of the researcher.In the intervention group massage for 5 days by mothers conducted in the procedure (venipuncture) pain is done, during and after the procedure will be calculated according to NIPS tool. Intervention 2: Control group: In the neonatal control group, they do not receive any intervention other than routine care, and the pain score before, during and after the procedure will be calculated according to the NIPS instrument. Yes - There is a plan to make this available What will be shared: Data is encrypted in order to make the identities of individuals unidentifiable and confidential When: From the end of sampling to 6 months after the publication of the article To whom: University Ethics Committee, Project Arbitration Committee, Article Arbitration Committee and other researchers Conditions: Perform systematic review or meta-analysis by mentioning the document Where to obtain: Dr. Hamidreza Khoshnezhad Ebrahimi How to obtain: After submitting the application via academic email, we will provide information files to individuals within a maximum of one week Comments:
public Dr.Hamidreza Khoshnezhad Ebrahimi
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2222 2045 khoshnezhad.hr@iums.ac.ir Iran University of Medical Sciences scientific Dr. Hamidreza Khoshnezhad Ebrahimi
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2222 2045 khoshnezhad.hr@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) It is possible for the mother to be with the baby 24 hours a day to feed the baby. Non-addiction of mothers to drugs and alcohol The baby is the result of a twin. The weight of the baby at birth is 2500 grams and more The gestational age of infants is 29 to 37 weeks Permission for complete oral feeding of the infant through the mother's breast is issued according to the doctor's instructions. Infants have stable clinical conditions Babies should not be undergoing phototherapy. - At least 3 days have passed since the baby was admitted to the neonatal care unit The baby should not be attached to equipment that prevents massaging of the baby's entire body, such as a chest tube or ventilator 1 day 30 days Both Discharge of the infant before the end of the intervention Disruption of stability and general conditions of mother and baby P07.30 Preterm newborn, unspecified weeks of gestation N/A N/A Intervention group: In the intervention group, a booklet with an educational CD about massage training prepared by the Department of Neonatal Health is given to mothers. (Massage from head to toe while the baby's body is uncovered or only has diapers). Massage training video for mothers is shown by the researcher. Massage training classes are held in the conference hall of the hospital. All health protocols are observed. Before rushing to class, their vital signs are checked and they are asked about the history of contact with a person with coronary artery, and gloves and masks are provided to them, and the class is performed individually. The training sessions are performed in 2 one-hour sessions. The mothers practiced the massage on the model in the presence of the researcher, through face-to-face training, if the mother needed more sessions and hours to train. It will continue until he learns to massage properly. Proper performance of massage The fact that all mothers have a correct understanding of massage training is controlled by the researcher by observing the massage performed by mothers on the replica. In all stages of film distribution to teach massage, and practical massage practice, the researcher will be present to provide more explanations and solve the problems and questions of mothers. The first massage of the baby was done by the mother, with the presence of the researcher.In the intervention group massage for 5 days by mothers conducted in the procedure (venipuncture) pain is done, during and after the procedure will be calculated according to NIPS tool. Control group: In the neonatal control group, they do not receive any intervention other than routine care, and the pain score before, during and after the procedure will be calculated according to the NIPS instrument. Pain. Timepoint: Before, during and after the intervention. Method of measurement: Neonatal Infant Pain Scale. Iran University of Medical Sciences Approved 2021-01-12 Ethics Committee of Iran University of Medical Sciences Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)