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IRCT20210502051155N1 IRCT 2021-09-18 University of social welfare and rehabilitation sciences Effect of PIOMI combined with music therapy on feeding of premature infants PIOMI Effect of PIOMI combined with music therapy on feeding progression of premature infants 2021-08-06 anticipated 58 Complete https://irct.ir/trial/56003 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be done based on the sequence created by the computer or using the site, the second step is to hide the random allocation, which is done using opaque and sealed envelopes, and Sequences will be recorded on the cards. At the time of registration, the envelopes are opened according to the order of entry of the envelopes and the allocation group is determined. People who are in random allocation and the person who assigns participants will be different, Blinding description: The intervention is presented by the researcher and the outcome assessment is performed by a trained nurse using the POFRAS index. N/A preterm infants. Intervention 1: Intervention group:5 minutes daily intervention of motor-oral intervention of preterm infants PIOMI and 10 minutes of presentation of Mozart music. It has 8 steps as follows: cheek stretch, lip roll, lip stretch, gum massage, lateral border of tongue and cheek, middle of tongue and palate, elicit a suck, support for non-nutritive sucking. The intervention is presented by a trained researcher and before stimulation, the hands are washed with disinfectant liquid and latex gloves are used. explanations about the intervention methods are provided to the parents and written consent is obtained from them. Personal and medical information, age and birth weight are recorded in the NICU based on the NICU file or by asking parents questions. The baby's daily weight is measured by a nurse on a scale and recorded on a daily information form. Stimulation takes place inside the incubator without leaving the infant. The intervention is performed individually, once a day for 10 days. If infants have physiological stability and did not show symptoms such as skin discoloration, slow heart rate, respiratory arrest, and stress symptoms (assessed by the POFRAS scale) we start intervention. The diagnosis is made by a pediatrician about the onset of oral feeding and how many times a day. Oral nutrition in this study means bottle feeding or breastfeeding and the criterion for achieving independent oral nutrition is eight oral feedings per day. In the final stage of PIOMI intervention, non-nutritional sucking (which lasts for 2 minutes), Mozart's music is played and lasts for another 8 minutes, with a final presentation of 10 minutes. The music is played by a disinfected speaker inside the incubator at a distance of 30 cm from the baby's ear with a intensity of 45dB. During interventions, ambient temperature and noise are kept constant, and doors are closed to minimize noise. Before, during, and after the stimulation is presented to the infant, the researcher monitors vital signs using a monitor, and if any symptoms of infant intolerance occur through the number of breaths, facial expressions, and gestures, the stimuli are stopped immediately. Technique: 1.Cheek C stretch:One finger in the cheek and one outside cheek.Slide and stretch tissue front to back toward the ear,& back to front.Move slowly.Do both cheeks twice. 2.Lip roll: Gently roll the lip between your thumb and finger (like rolling a pea).Roll both sides of upper lip once.Roll both sides of lower lip once. 3.Lip curl or lip stretch: Compress lip between thumb and finger,and curl downward.Curl both sides of upper lip once,and both sides of lower lip once.If lip is too small to grip for the curl,do the Lip Stretch:Lay finger across upper lip,gently compress and stretch side to sideRepeat on lower lip. 4.Gum massage: Use finger to put gentle pressure on outside of upper gum.Move finger slowly around upper gum to other side of mouth. (Be sure to touch outer gum surface,not biting surface.)Repeat on lower gum. 5.Lateral border of tongue/cheeks: Put finger beside ongue and push to the middle.Then move finger back into cheek,stretching it.Repeat on the other side of tongue/cheek. 6.Midblade of tongue/palate: Use finger to put pressure on roof of mouth for 3 seconds.Move finger down to tongue and gently press tongue down.Move finger back up to hard palate.Repeat these movements twice. 7.Elicit a suck: Put finger or pacifier on tongue and gently stroke to allow sucking. 8.Support for non nutritive sucking: Allow sucking on finger or pacifier for 2 minutes. Intervention 2: Control group: 5 minutes of PIOMI intervention is provided. It has 8 steps as follows: cheek stretch, lip roll, lip stretch, gum massage, lateral border of tongue and cheek, middle of tongue and palate, elicit a suck, support for non-nutritive sucking. The intervention is presented by a trained researcher and before stimulation, the hands are washed with disinfectant liquid and latex gloves are used. explanations about the intervention methods are provided to the parents and written consent is obtained from them. Personal and medical information, age and birth weight are recorded in the NICU based on the NICU file or by asking parents questions. The baby's daily weight is measured by a nurse on a scale and recorded on a daily information form. Stimulation takes place inside the incubator without leaving the infant. The intervention is performed individually, once a day for 10 days. If infants have physiological stability and did not show symptoms such as skin discoloration, slow heart rate, respiratory arrest, and stress symptoms (assessed by the POFRAS scale) we start intervention. The diagnosis is made by a pediatrician about the onset of oral feeding and how many times a day. Oral nutrition in this study means bottle feeding or breastfeeding and the criterion for achieving independent oral nutrition is eight oral feedings per day. Yes - There is a plan to make this available What will be shared: There is no more information When: There is no more information To whom: There is no more information Conditions: There is no more information Where to obtain: There is no more information How to obtain: There is no more information Comments:
public Elmira Shokri
University of social welfare and rehabilitation science, Kodakyar Ave., Daneshjo Blvd.,Tehran,Iran
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7644 4705 e.sh855@yahoo.com University of social welfare and rehabilitation sciences scientific Elmira Shokri
University of social welfare and rehabilitation science, Kodakyar Ave., Daneshjo Blvd.,Evin,Tehran,Iran
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7644 4705 e.sh855@yahoo.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Post-menstrual age between 26 and 30 weeks at birth Physiological stability and lack of stress symptoms when presenting stimuli Apgar score 7 and above in 5 minutes after birth Obtaining written consent from parents in order to participate in the research Absence of any congenital anomalies and chronic medical problems such as asphyxia , neonatal seizures, grade 3 and 4 intraventricular hemorrhage, necrotizing enterocolitis, bronchopulmonary dysplasia, jaundice, and hearing loss. Infants who have started gavage feeding by the end of the 30th week of pregnancy. 182 days 210 days Both Parental disapproval or transfer to other health center P92.9 Feeding problem of newborn, unspecified Rehabilitation Rehabilitation Intervention group:5 minutes daily intervention of motor-oral intervention of preterm infants PIOMI and 10 minutes of presentation of Mozart music. It has 8 steps as follows: cheek stretch, lip roll, lip stretch, gum massage, lateral border of tongue and cheek, middle of tongue and palate, elicit a suck, support for non-nutritive sucking. The intervention is presented by a trained researcher and before stimulation, the hands are washed with disinfectant liquid and latex gloves are used. explanations about the intervention methods are provided to the parents and written consent is obtained from them. Personal and medical information, age and birth weight are recorded in the NICU based on the NICU file or by asking parents questions. The baby's daily weight is measured by a nurse on a scale and recorded on a daily information form. Stimulation takes place inside the incubator without leaving the infant. The intervention is performed individually, once a day for 10 days. If infants have physiological stability and did not show symptoms such as skin discoloration, slow heart rate, respiratory arrest, and stress symptoms (assessed by the POFRAS scale) we start intervention. The diagnosis is made by a pediatrician about the onset of oral feeding and how many times a day. Oral nutrition in this study means bottle feeding or breastfeeding and the criterion for achieving independent oral nutrition is eight oral feedings per day. In the final stage of PIOMI intervention, non-nutritional sucking (which lasts for 2 minutes), Mozart's music is played and lasts for another 8 minutes, with a final presentation of 10 minutes. The music is played by a disinfected speaker inside the incubator at a distance of 30 cm from the baby's ear with a intensity of 45dB. During interventions, ambient temperature and noise are kept constant, and doors are closed to minimize noise. Before, during, and after the stimulation is presented to the infant, the researcher monitors vital signs using a monitor, and if any symptoms of infant intolerance occur through the number of breaths, facial expressions, and gestures, the stimuli are stopped immediately. Technique: 1.Cheek C stretch:One finger in the cheek and one outside cheek.Slide and stretch tissue front to back toward the ear,& back to front.Move slowly.Do both cheeks twice. 2.Lip roll: Gently roll the lip between your thumb and finger (like rolling a pea).Roll both sides of upper lip once.Roll both sides of lower lip once. 3.Lip curl or lip stretch: Compress lip between thumb and finger,and curl downward.Curl both sides of upper lip once,and both sides of lower lip once.If lip is too small to grip for the curl,do the Lip Stretch:Lay finger across upper lip,gently compress and stretch side to sideRepeat on lower lip. 4.Gum massage: Use finger to put gentle pressure on outside of upper gum.Move finger slowly around upper gum to other side of mouth. (Be sure to touch outer gum surface,not biting surface.)Repeat on lower gum. 5.Lateral border of tongue/cheeks: Put finger beside ongue and push to the middle.Then move finger back into cheek,stretching it.Repeat on the other side of tongue/cheek. 6.Midblade of tongue/palate: Use finger to put pressure on roof of mouth for 3 seconds.Move finger down to tongue and gently press tongue down.Move finger back up to hard palate.Repeat these movements twice. 7.Elicit a suck: Put finger or pacifier on tongue and gently stroke to allow sucking. 8.Support for non nutritive sucking: Allow sucking on finger or pacifier for 2 minutes. Control group: 5 minutes of PIOMI intervention is provided. It has 8 steps as follows: cheek stretch, lip roll, lip stretch, gum massage, lateral border of tongue and cheek, middle of tongue and palate, elicit a suck, support for non-nutritive sucking. The intervention is presented by a trained researcher and before stimulation, the hands are washed with disinfectant liquid and latex gloves are used. explanations about the intervention methods are provided to the parents and written consent is obtained from them. Personal and medical information, age and birth weight are recorded in the NICU based on the NICU file or by asking parents questions. The baby's daily weight is measured by a nurse on a scale and recorded on a daily information form. Stimulation takes place inside the incubator without leaving the infant. The intervention is performed individually, once a day for 10 days. If infants have physiological stability and did not show symptoms such as skin discoloration, slow heart rate, respiratory arrest, and stress symptoms (assessed by the POFRAS scale) we start intervention. The diagnosis is made by a pediatrician about the onset of oral feeding and how many times a day. Oral nutrition in this study means bottle feeding or breastfeeding and the criterion for achieving independent oral nutrition is eight oral feedings per day. Feeding progression. Timepoint: Before the intervention and day 5 and 10 of the intervention. Method of measurement: Preterm Oral Feeding Readiness Assessment Scale(POFRAS). Days of NICU hospitalization. Timepoint: daily. Method of measurement: Counting the days. Average weight gain. Timepoint: daily. Method of measurement: scale-gramme. Weight. Timepoint: daily. Method of measurement: scale-gramme. Gestational age. Timepoint: daily. Method of measurement: Number of days. University of social welfare and rehabilitation sciences Approved 2021-07-17 Ethics committee of university of social welfare and rehabilitation sciences University of social welfare and rehabilitation science, Kodakyar Ave., Daneshjo Blvd.,Evin,,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)