]>
IRCT20200106046027N1 IRCT 2020-02-17 Mazandaran University of Medical Sciences Effect of Touch Therapy on Infant Growth The effect of tactile stimulation of movement by the mother's physical growth of premature infants 2020-04-20 anticipated 100 Complete https://irct.ir/trial/44914 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Neonates are allocated in blocks of 4. Blocks are created by sealedenvelope website. N/A Prematurity. Intervention 1: Intervention group: Neonates in this group will receive 45 minutes daily massage in addition to standard care. The 45 minutes massage is delivered in three 15 minutes episodes for ten days. The 15 minutes massage are divided into three 5 minutes intervals. In the first and last phase, the neonate is placed in the prone position and touched with finger pulps of both hands. The following five areas are touched every minute: Twelve touch movements (one every 5 seconds) from the tip of the head downward to the face, neck and vice versa. Twelve touch movements (one every 5 seconds) from the back of the neck across the shoulders and vice versa. Twelve Touch movement (one every 5 seconds) from the upper back to the lower back and vice versa. Twelve Touch movement (one every 5 seconds) from the thighs down to the ankle and vice versa. Twelve touch movement (one every 5 seconds) from shoulder to wrist and vice versa. In the middle phase, the neonate is placed in the supine position and six passive extension-flexion movements (one every 10 seconds) are given in the following five areas: Right and left arms, Right foot and left legs, and both feet. The intervention will be performed between 7 a.m and 7 p.m. Intervention 2: Control group: Control group neonates will receive regular care of the ward. Yes - There is a plan to make this available What will be shared: all collected deidentified data for primary and secondary outcome measures are going to be shared When: After publishing the study, data are going to be available To whom: Data are going to be available to all researchers and clinician irrespective to their employment sector Conditions: Permission are granted upon request for secondary and meta-analysis Where to obtain: Requests are gathered through principle researcher's e-mail address How to obtain: Upon verification of request and reason data are given in three month. Comments:
public Hossein
Taleghani Ave, No.20
Ramsar Iran (Islamic Republic of) 4815733971 +98 11 5522 6108 firoozi.hosein@mazums.ac.ir Mazandaran University of Medical Sciences scientific Hossein
Taleghani Ave, No.20
Ramsar Iran (Islamic Republic of) 4815733971 +98 11 5522 6108 firoozi.hosein@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) More than 5 days of age gestational age < 37 weeks Birth weight between 1000 to 1500 grams Exclusive breast feeding 5 days 5 days Both Congenital anomalies Mother with alcohol, cigarette or drug addiction Prior history of surgery P05 Disorders of newborn related to slow fetal growth and fetal malnutrition Treatment - Other Treatment - Other Intervention group: Neonates in this group will receive 45 minutes daily massage in addition to standard care. The 45 minutes massage is delivered in three 15 minutes episodes for ten days. The 15 minutes massage are divided into three 5 minutes intervals. In the first and last phase, the neonate is placed in the prone position and touched with finger pulps of both hands. The following five areas are touched every minute: Twelve touch movements (one every 5 seconds) from the tip of the head downward to the face, neck and vice versa. Twelve touch movements (one every 5 seconds) from the back of the neck across the shoulders and vice versa. Twelve Touch movement (one every 5 seconds) from the upper back to the lower back and vice versa. Twelve Touch movement (one every 5 seconds) from the thighs down to the ankle and vice versa. Twelve touch movement (one every 5 seconds) from shoulder to wrist and vice versa. In the middle phase, the neonate is placed in the supine position and six passive extension-flexion movements (one every 10 seconds) are given in the following five areas: Right and left arms, Right foot and left legs, and both feet. The intervention will be performed between 7 a.m and 7 p.m. Control group: Control group neonates will receive regular care of the ward. Head Circumference. Timepoint: at birth, before intervention and 1, 2, 3 month after intervention. Method of measurement: Measuring tape. Height. Timepoint: at birth, before intervention and 1, 2, 3 month after intervention. Method of measurement: Measuring tape. Weight. Timepoint: at birth, before intervention and 1, 2, 3 month after intervention. Method of measurement: Scale. Mazandaran University of Medical Sciences Approved 2017-02-28 Ethics committee of mazandaran University of Medical Sciences No. 20, Taleghani Ave. Ramsar Mazandaran Iran (Islamic Republic of)