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IRCT20160228026817N4 IRCT 2023-05-10 Shiraz University of Medical Sciences Comparison of the effect of the smell of breast milk and vanilla extract on the duration of the transition from gavage to oral feeding, weighing, and length of stay of premature infants Comparison of the effect of breast milk smell and vanilla extract on the duration of the transition from gavage to oral feeding, weighing, and length of stay of premature infants in special care units of hospitals affiliated with Shiraz University of Medical Sciences in 2023-2024 2023-05-04 anticipated 61 Complete https://irct.ir/trial/69014 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: For randomization, the permuted block method will be used and people in three groups will be assigned to 10 blocks of 6. Allocation will be done by Random allocation software. In order to assign people to three groups, the intervention group with the scent of vanilla with the English letter A, the intervention group with the scent of mother's milk with the English letters B, and the control group with the English letters C are considered, and the different permutations of the ABC chain are written and given a code. The codes are CBA, CAB, BAC, ACB, ABC, and each time the groups are assigned, a number between 1 and 6 is randomly selected. N/A The duration of transition from gavage to oral feeding, weighing and length of stay of premature babies. Intervention 1: First intervention group: Vanilla. In the present study, simultaneously with the start of gavage, olfactory stimulation was performed in the intervention group with a pad soaked in 1 cc of a concentration of 6 mg in 100 ccs of vanilla extract at 9 am, 12 noon, 3 pm, and 6 pm. Gavage is completed and olfactory stimulation is removed, which continues until the mother's breastfeeding begins. Intervention 2: The second intervention group: is breast milk. In the present study, at the same time as the gavage begins, at 9:00 AM, 12:00 PM, 3:00 PM, and 6:00 PM, olfactory stimulation is performed and in the intervention group with a pad soaked in 1 cc of breast milk, and after the end of the gavage And the olfactory stimulus is removed, which continues until the start of feeding from the mother's breast. Intervention 3: Control group: In the present study, at the same time as the gavage begins, olfactory stimulation is performed in the intervention group with a pad soaked in 1 cc of sweet almond oil at 9 am, 12 noon, 3 pm, and 6 pm, and after the end of the gavage and The olfactory stimulation is removed, which continues until the mother's breastfeeding begins. 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 further information.
public Neda Jamalimoghadam
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Shiraz Iran (Islamic Republic of) ۱۳۱۱۹ - ۷۱۹۳۶ +98 71 3647 4257 nedajamali21@yahoo.com Shiraz University of Medical Sciences scientific Neda Jamalimoghadam
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Shiraz Iran (Islamic Republic of) ۱۳۱۱۹ - ۷۱۹۳۶ +98 71 3647 4257 nedajamali21@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Gestational age 27-33 weeks (who have weakness and inability to suck) Birth weight of at least 1 Kg Apgar score greater than 6 in the first and fifth minutes Not having any health-threatening congenital abnormalities No underlying or acquired diseases except prematurity Breast feeding 1 day 30 days Both Previous patient participation in studies similar to the current study Other Other N/A First intervention group: Vanilla. In the present study, simultaneously with the start of gavage, olfactory stimulation was performed in the intervention group with a pad soaked in 1 cc of a concentration of 6 mg in 100 ccs of vanilla extract at 9 am, 12 noon, 3 pm, and 6 pm. Gavage is completed and olfactory stimulation is removed, which continues until the mother's breastfeeding begins. The second intervention group: is breast milk. In the present study, at the same time as the gavage begins, at 9:00 AM, 12:00 PM, 3:00 PM, and 6:00 PM, olfactory stimulation is performed and in the intervention group with a pad soaked in 1 cc of breast milk, and after the end of the gavage And the olfactory stimulus is removed, which continues until the start of feeding from the mother's breast Control group: In the present study, at the same time as the gavage begins, olfactory stimulation is performed in the intervention group with a pad soaked in 1 cc of sweet almond oil at 9 am, 12 noon, 3 pm, and 6 pm, and after the end of the gavage and The olfactory stimulation is removed, which continues until the mother's breastfeeding begins. The duration of the transition from gavage to oral feeding. Timepoint: The distance from the start of gavage feeding to oral feeding. Method of measurement: According to the patient's file. Weighing. Timepoint: Birth weight, weight at entry into the study, and weight at the time of feeding transfer. Method of measurement: Scale. Duration of Stay of premature babies. Timepoint: According to the patient's file. Method of measurement: Registration in the patient file. Improving the quality of life. Timepoint: From admission to discharge. Method of measurement: The number of hospitalization days of infants in the intervention group is compared with the control group and recorded in the designed table. Decreasing parental anxiety. Timepoint: Birth weight, weight at the time of intervention, and weight at the time of discharge is measured. Method of measurement: Standard digital scale available in the department. Shiraz University of Medical Sciences Approved 2023-04-29 Ethics Committee of Shiraz University of Medical Sciences Zand Street, in front of Palestine Street, Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)