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IRCT20250707066394N1 IRCT 2025-08-10 Babol University of Medical Sciences Studying the effect of massage on premature infants by mothers The effect of Waimala and Field infant massage by mothers on self-esteem, maternal self-efficacy, and perceived social support in primiparous mothers of preterm infants. 2025-08-08 anticipated 90 Complete https://irct.ir/trial/84615 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: This study is a parallel randomized controlled trial, given that not all infants and toddlers will be enrolled at the same time, and the researchers cannot predict in advance which group each infant entering the study will belong to.The three groups will be assigned using the Block Randomization method. In order to conceal the random assignment, the codes generated by the software will be placed in opaque envelopes so that it is not clear which group the next person will be placed in. Randomization is the cornerstone of a good intervention study. One of the most important biases that we face in such studies is selection bias, which can best be controlled by using randomization. With this randomization method, we can eliminate the effects of variables that play a role as confounders in examining the study objectives and we have identified these variables, and this method is also able to eliminate the effects of confounders that were not measured or identified. In this study, eligible male participants will be randomly assigned to one of three control and intervention groups in a 1:1:1 ratio in blocks of 6, after receiving informed consent, in a manner that the researcher cannot predict which intervention group the next person will be placed in. The codes will be placed in opaque envelopes, and with each new person entering, the envelope will be opened and the person's belonging to the relevant group will be determined. N/A Premature babies. Intervention 1: .Intervention group: Vaimala massage: Various pressure and movements are used on the soft tissues of the body and help reduce pain, relieve muscle tension, and calm the mind. 2) Vaimala technique: The massage is performed in two phases for 15 minutes as follows: Phase 1: In the supine position. 1) Face: From the forehead to the sides of the face. Then in front of the ears and jaw with circular movements. 2) Chest: From the center of the chest outward along the ribs and then in the reverse direction. 3) Arms and hands: From the shoulder to the wrist and fingers on both hands with circular movements (Indian milking). 4) Abdomen: (I Love You method) From the upper left side of the abdomen (under the ribs) downwards, from the right side and lower abdomen upwards and then across the abdomen to the left and then repeat the first stage, continuously. 5) Legs: From the thighs to the knees and calves on both legs (Indian milking). The second phase in the prone position: The hands move perpendicular to the spine, from the waist to the neck and vice versa. The movement of the hands is with medium pressure while the baby's body is smeared with olive oil. Each mother will massage her baby with odorless olive oil for 5 consecutive days, daily, and for 15 minutes each day, three times. The olive oil used for all samples will be from Utab Teb Company. After teaching the massage techniques to the mothers, in the intervention groups, each mother will massage her baby with unscented olive oil for 5 consecutive days, daily, for 15 minutes three times a day. Then, data will be collected through questionnaires of self-esteem (Rosenberg), maternal competence (Gibaud-Wallston), and perceived social support (Zimt) on the first and fifth days of the intervention. Intervention 2: Two-field intervention group: This technique, based on pressure contacts and stretching movements, has several effects on the mother's mental health. 2) Vaimala technique: Massage is performed in two phases for 15 minutes as follows: First phase in the supine position: 1) Face: From the forehead to the sides of the face. Then in front of the ears and jaw with circular movements. 2) Chest: From the center of the chest outward along the ribs and then in the reverse direction. 3) Arms and hands: From the shoulder to the wrist and fingers on both hands with circular movements (Indian milking). 4) Abdomen: (I Love You method) From the upper left side of the abdomen (under the ribs) downwards, from the right side and lower abdomen upwards and then across the abdomen to the left and then repeat the first stage continuously. 5) Legs: From the thighs to the knees and calves on both legs (Indian milking). The second phase in the prone position: The hands move perpendicular to the spine, from the waist to the neck and vice versa. The movement of the hands is with medium pressure while the baby's body is smeared with olive oil. Each mother will massage her baby with odorless olive oil for 5 consecutive days, daily, and for 15 minutes each day, three times. The olive oil used for all samples will be from Utab Teb Company. After teaching the massage techniques to the mothers, in the intervention groups, each mother will massage her baby with unscented olive oil for 5 consecutive days, daily, for 15 minutes three times a day. Then, data will be collected through questionnaires of self-esteem (Rosenberg), maternal competence (Gibaud-Wallston), and perceived social support (Zimt) on the first and fifth days of the intervention. Intervention 3: Control group: Control group: A control group in which no intervention is performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I haven't decided yet.
public Dr. Parvin Aziznejad Roshan
Babol University of Medical Sciences, Faculty of Nursing and Midwifery, Department of Pediatric Nursing
Babol Iran (Islamic Republic of) 47176-47745 +98 911 113 7562 aziznejadroshan@yahoo.com Babol University of Medical Sciences scientific Dr. Parvin Aziznejad Roshan
Babol University of Medical Sciences, Faculty of Nursing and Midwifery
Babol Iran (Islamic Republic of) 47176-47745 +98 911 113 7562 aziznejadroshan@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) 1) Intrauterine age 36-28 weeks 2) No congenital abnormalities or severe respiratory disease 3) No infection or skin rash for infant massage 4) Infant should not have coagulation problems or any problems that may provoke bleeding 196 days 252 days Both 1) Mothers working in healthcare and medical environments 2) Mothers addicted to drugs and alcohol 3) Mothers are literate 4) Having experience in massage classes 5) Mothers suffering from mental or chronic illness based on the patient's file P07.2 Extreme immaturity of newborn Treatment - Other Treatment - Other Treatment - Other .Intervention group: Vaimala massage: Various pressure and movements are used on the soft tissues of the body and help reduce pain, relieve muscle tension, and calm the mind. 2) Vaimala technique: The massage is performed in two phases for 15 minutes as follows: Phase 1: In the supine position. 1) Face: From the forehead to the sides of the face. Then in front of the ears and jaw with circular movements. 2) Chest: From the center of the chest outward along the ribs and then in the reverse direction. 3) Arms and hands: From the shoulder to the wrist and fingers on both hands with circular movements (Indian milking). 4) Abdomen: (I Love You method) From the upper left side of the abdomen (under the ribs) downwards, from the right side and lower abdomen upwards and then across the abdomen to the left and then repeat the first stage, continuously. 5) Legs: From the thighs to the knees and calves on both legs (Indian milking). The second phase in the prone position: The hands move perpendicular to the spine, from the waist to the neck and vice versa. The movement of the hands is with medium pressure while the baby's body is smeared with olive oil. Each mother will massage her baby with odorless olive oil for 5 consecutive days, daily, and for 15 minutes each day, three times. The olive oil used for all samples will be from Utab Teb Company. After teaching the massage techniques to the mothers, in the intervention groups, each mother will massage her baby with unscented olive oil for 5 consecutive days, daily, for 15 minutes three times a day. Then, data will be collected through questionnaires of self-esteem (Rosenberg), maternal competence (Gibaud-Wallston), and perceived social support (Zimt) on the first and fifth days of the intervention Two-field intervention group: This technique, based on pressure contacts and stretching movements, has several effects on the mother's mental health. 2) Vaimala technique: Massage is performed in two phases for 15 minutes as follows: First phase in the supine position: 1) Face: From the forehead to the sides of the face. Then in front of the ears and jaw with circular movements. 2) Chest: From the center of the chest outward along the ribs and then in the reverse direction. 3) Arms and hands: From the shoulder to the wrist and fingers on both hands with circular movements (Indian milking). 4) Abdomen: (I Love You method) From the upper left side of the abdomen (under the ribs) downwards, from the right side and lower abdomen upwards and then across the abdomen to the left and then repeat the first stage continuously. 5) Legs: From the thighs to the knees and calves on both legs (Indian milking). The second phase in the prone position: The hands move perpendicular to the spine, from the waist to the neck and vice versa. The movement of the hands is with medium pressure while the baby's body is smeared with olive oil. Each mother will massage her baby with odorless olive oil for 5 consecutive days, daily, and for 15 minutes each day, three times. The olive oil used for all samples will be from Utab Teb Company. After teaching the massage techniques to the mothers, in the intervention groups, each mother will massage her baby with unscented olive oil for 5 consecutive days, daily, for 15 minutes three times a day. Then, data will be collected through questionnaires of self-esteem (Rosenberg), maternal competence (Gibaud-Wallston), and perceived social support (Zimt) on the first and fifth days of the intervention. Control group: Control group: A control group in which no intervention is performed. 1- self-esteem. Timepoint: Questionnaires are given on the first and fifth days of the intervention. Method of measurement: 1-Questionnaire Rosenberg Self-Esteem Scale. 2-Gibaud-Wallston Parental Competence. Timepoint: Questionnaires are given on the first and fifth days of the intervention. Method of measurement: 2-Gibbaud-Wallston Parental Competence Questionnaire). 3-Zimmet Perceived Social Competence Questionnaire. Timepoint: Questionnaires are given on the first and fifth days of the intervention. Method of measurement: 3- Questionnaire perceived social support. Babol University of Medical Sciences Approved 2025-06-30 Ethics Committee of Babol University of Medical Sciences Zirab, Azadi St., Shahid Kamil Imani Blvd., Zirab Martyrs Hospital zirab Mazandaran Iran (Islamic Republic of)