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IRCT20220409054461N2 IRCT 2024-03-16 Qazvin University of Medical Sciences The effect of listening to the Holy Quran recitation on the time for transition from gavage to the first oral feeding, weight gain, and the length of hospital stay of preterm infants The effect of listening to the Holy Quran recitation on the time for transition from gavage to the first oral feeding, weight gain, and the length of hospital stay of preterm infants in the neonatal intensive care unit 2024-03-10 anticipated 64 Complete https://irct.ir/trial/75760 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: The study will include two groups including the intervention and control group, which will be conducted among preterm infants . The selection of persons to enter the study will be made on the infants of the criteria for entering the study and upon receipt of written consent from their parents. People entering the study will be randomly simplified into two groups of equal numbers, Randomization description: This study will be performed experimentally and randomly in two groups of test and control. For this purpose, a table of random numbers is used. In this way, the researcher will first determine that all the people to whom the odd number is assigned to be in the control group and those to whom the even number is assigned to be in the test group.He will then close his eyes and place his finger on one of the digits in the random number table. The researcher will select the required number of even and odd numbers by moving in the table of random numbers. All numbers will be placed in separate envelopes and all will be placed in a box. When the sample enters the study easily with the entry conditions, then the number one card will be returned to him and depending on whether this card has an even or odd number will be in one of two test or control groups, Blinding description: The study will include two groups including the intervention and control group, which will be conducted among preterm infants . The selection of persons to enter the study will be made on the infants of the criteria for entering the study and upon receipt of written consent from their parents. People entering the study will be randomly simplified into two groups of equal numbers. In this study, infant doctors, nurses and parents of infants will also be blinded in study groups. It should be explained that the intervention, data collection and data entry will also be carried out by the researcher himself. N/A Infants, children, nursing, the sound of the Qur'an. Intervention 1: Intervention group: The intervention was conducted during the evening shifts between 14:00 and 20:00, leveraging the quieter atmosphere of the ward during this time. The infants were first placed in a nest in the supine position and then connected to monitors by the responsible nurses. Specialized headphones were individually fitted for each infant and positioned correctly on their ears. If an infant showed agitation during this process, the headphones were temporarily removed and repositioned after a short interval. It should be noted that, in order to prevent the effects of headphones, they were placed on the ears of the infants in both groups. For participants in the intervention group, a recitation from the Holy Quran comprising verses 78 to the end of Surah Al-Isra was played at an intensity of 45 decibels. This level of sound was carefully calibrated to both adhere to safe sound ranges and effectively mask ambient noise. The participants listened to the Holy Quran recitation three times a day, lasting for a duration if 10-20 minutes, starting three days after the initiation of gavage feeding until they transitioned to their first oral feeding. Intervention 2: Control group:No sound will be played for participants in the control group. 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 there is no anymore data
public Farnoosh Rashvand
College of Nursing and Midwifery, Shahid Bahonar Blvd., Qazvin
qazvin Iran (Islamic Republic of) 3491759811 +98 28 3333 8127 n.rashvand@yahoo.com Qazvin University of Medical Sciences scientific Farnoosh Rashvand
College of Nursing and Midwifery, Shahid Bahonar Blvd., Qazvin
qazvin Iran (Islamic Republic of) 3491759811 +98 28 3333 8127 n.rashvand@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) obtaining parental consent for the infant’s participation possessing normal hearing no history of neurological or cognitive abnormalities no head-related injuries stable vital signs over the past 12 hours overall clinical stability achieving an Apgar score of ≥7 in the first and fifth minutes after birth. infants had to be fed with either breast milk or formula. 1 day 1 month Both involved any manifestation of stress-related symptoms during the intervention the necessity for therapeutic or care interventions during the study decrease in the level of consciousness Other Other Intervention group: The intervention was conducted during the evening shifts between 14:00 and 20:00, leveraging the quieter atmosphere of the ward during this time. The infants were first placed in a nest in the supine position and then connected to monitors by the responsible nurses. Specialized headphones were individually fitted for each infant and positioned correctly on their ears. If an infant showed agitation during this process, the headphones were temporarily removed and repositioned after a short interval. It should be noted that, in order to prevent the effects of headphones, they were placed on the ears of the infants in both groups. For participants in the intervention group, a recitation from the Holy Quran comprising verses 78 to the end of Surah Al-Isra was played at an intensity of 45 decibels. This level of sound was carefully calibrated to both adhere to safe sound ranges and effectively mask ambient noise. The participants listened to the Holy Quran recitation three times a day, lasting for a duration if 10-20 minutes, starting three days after the initiation of gavage feeding until they transitioned to their first oral feeding. Control group:No sound will be played for participants in the control group The time for transition from gavage to the first oral feeding. Timepoint: before the intervention and 3 days after the intervention. Method of measurement: Number of days based on the calendar. The amount of weight gain that the scale shows. Timepoint: before the intervention and 3 days after the intervention. Method of measurement: Seca weight digital scale with an accuracy of ±10 grams. Length of hospitalization of premature infants. Timepoint: before the intervention and 3 days after the intervention. Method of measurement: The number of days based on the infants document. Qazvin University of Medical Sciences Approved 2024-01-20 Ethics Committee of Qazvin University of Medical Sciences Qazvin, Shahid Bahner Boulevard, the campus building of the University Qazvin Qazvin Iran (Islamic Republic of)