]>
IRCT20250622066216N1 IRCT 2025-12-04 Shahid Beheshti University of Medical Sciences Effect of massage therapy on neonatal hyperbilirubinemia Investigating the effect of two massage-therapy methods on defecation of newborns with indirect hyperbilirubinemia 2025-10-22 anticipated 90 Complete https://irct.ir/trial/84388 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Neonatal indirect hyprerbilirubinemia. Intervention 1: Intervention group1: The Spinal massage therapy group is based on standard guidelines and under the supervision of a physical medicine professor. This massage is performed on hospitalized newborns with hyperbilirubinemia. These newborns receive the main treatment of phototherapy in the ward to reduce jaundice, and abdominal massage therapy is performed as an adjuant treatment during the hospitalization period, three times a day, each time for 15 minutes. The mother is taught how to perform the massages, and a trained nurse also monitors the proper implementation of the massages. All these newborns receive the standard treatment for jaundice, which is phototherapy. The massages are also written on a pamphlet and the steps are taught in simple language. Intervention 2: Intervention group 2:The abdominal massage therapy group is based on standard guidelines and under the supervision of a physical medicine professor. This massage is performed on hospitalized newborns with hyperbilirubinemia. These newborns receive the main treatment of phototherapy in the ward to reduce jaundice, and abdominal massage therapy is performed as an adjuant treatment during the hospitalization period, three times a day, each time for 15 minutes. The mother is taught how to perform the massages, and a trained nurse also monitors the proper implementation of the massages. All these newborns receive the standard treatment for jaundice, which is phototherapy. The massages are also written on a pamphlet and the steps are taught in simple language. Intervention 3: Control group: There are babies who are hospitalized in the ward due to hyperbilirubinemia and only receive phototherapy as the main treatment and do not receive any type of massage as an adjunctive treatment. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after individuals are anonymized. When: Access period starts 6 months after the publication of results To whom: Researchers working in academic and scientific institutions Conditions: The request submitted to the Scientific Committee of the Neonatal Research Center will be reviewed and, if approved, will be made available. Where to obtain: Contact the project manager Dr. Parinaz Alizadeh at the email address p.alizadeh@sbmu.ac.ir How to obtain: After sending the request via email, the data will be made available within a maximum of one week if approved by the project manager. Comments:
public Parinaz Alizadeh
No.1146, Shariati Street - above Hosseiniyeh Ershad
Tehran Iran (Islamic Republic of) 1551415468 +98 21 2222 7021 p.alizadeh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Parinaz Alizadeh
No. 1146, Shariati St-above hosseinieh irshad-Mofid Childrens Hospital
Tehran Iran (Islamic Republic of) 1551415468 +98 21 2222 7021 p.alizadeh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Neonates with indirect hyperbilirubinemia admit for phototherapy Birth weight above 2500gr Gestational age above 37 weeks 1 day 28 days Both Need exchange transfusion Need medication for hyperbilirubinemia treatment Direct hyperbilirubinemia Neonates with abdominal or spinal problems R17 Unspecified jaundice Treatment - Other Treatment - Other Treatment - Other Intervention group1: The Spinal massage therapy group is based on standard guidelines and under the supervision of a physical medicine professor. This massage is performed on hospitalized newborns with hyperbilirubinemia. These newborns receive the main treatment of phototherapy in the ward to reduce jaundice, and abdominal massage therapy is performed as an adjuant treatment during the hospitalization period, three times a day, each time for 15 minutes. The mother is taught how to perform the massages, and a trained nurse also monitors the proper implementation of the massages. All these newborns receive the standard treatment for jaundice, which is phototherapy. The massages are also written on a pamphlet and the steps are taught in simple language. Intervention group 2:The abdominal massage therapy group is based on standard guidelines and under the supervision of a physical medicine professor. This massage is performed on hospitalized newborns with hyperbilirubinemia. These newborns receive the main treatment of phototherapy in the ward to reduce jaundice, and abdominal massage therapy is performed as an adjuant treatment during the hospitalization period, three times a day, each time for 15 minutes. The mother is taught how to perform the massages, and a trained nurse also monitors the proper implementation of the massages. All these newborns receive the standard treatment for jaundice, which is phototherapy. The massages are also written on a pamphlet and the steps are taught in simple language. Control group: There are babies who are hospitalized in the ward due to hyperbilirubinemia and only receive phototherapy as the main treatment and do not receive any type of massage as an adjunctive treatment. The trend of decreasing indirect bilirubin. Timepoint: Immediately after hospitalization: 6, 12, and 24 hours post-admission. Method of measurement: Measurement of serum bilirubin level by venous blood sampling. Frequency of bowel movements. Timepoint: During the entire hospitalization. Method of measurement: Record in file. Length of hospital stay. Timepoint: First day of hospitalization - Last day of hospitalization. Method of measurement: The number of days the newborn was hospitalized from the time of admission to the ward until discharge, recorded in the file. Hospitalization cost. Timepoint: First day of hospitalization - Last day of hospitalization. Method of measurement: Estimated daily hospitalization cost in the ward based on the calculated expenses of the hospital's financial department. Shahid Beheshti University of Medical Sciences Approved 2025-10-08 Research Ethics Committees Of School Of Medicine-Shahid Beheshti University Of Medical Science Third Floor-Medical University-Chamran Highway Tehran Tehran Iran (Islamic Republic of)