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IRCT20230423057977N1 IRCT 2023-06-20 Tehran University of Medical Sciences The effect of premature infant oral motor intervention by the mother on mothers' mood Effectiveness of Premature Infant Oromotor Intervention by mother on the situation of mood in mothers of premature infants 2023-06-22 anticipated 74 Complete https://irct.ir/trial/69736 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Two hospitals of Al-Zahra and 17 of Shahrivar were selected by lottery to collect samples for the control and intervention groups, Blinding description: In order to prevent the exchange of information between the mothers of the two control and intervention groups, from the two hospitals of 17 Shahrivar and Al-Zahra Rasht, one control group and the other intervention group will be collected by lottery. The intervention group is selected from 17 Shahrivar Hospital in Rasht and the control group is selected from Al-Zahra Hospital. N/A Mood. Intervention 1: Intervention group: The mood questionnaire will be filled in at the beginning of the study by the mother, who both herself and her baby meet the inclusion criteria. And oral motor intervention of the premature baby is taught to the mother by the researcher on the doll and educational videos. Then, after appropriate feedback, this intervention will be performed by the mother on her baby under the supervision of the researcher and speech therapy for 10 days. And the mood questionnaire will be completed again by the mother after 10 days of intervention. Intervention 2: Control group: The mood questionnaire will be completed at the beginning of the study by mothers who both themselves and their babies meet the entry criteria. And 10 days later, this questionnaire is filled again by mothers. During these 10 days, the baby will be cared for according to the department's routine. 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 have to make my final decision about publishing the data files in consultation with the supervisor.
public Sahar Hosseinzadeh
NICU, Dr Pirooz hospital, Keshavarz Blvd
Lahijan Iran (Islamic Republic of) 43111-44199 +98 21 4223 5503 sahar.hosseinzadeh@ymail.com Tehran University of Medical Sciences scientific Sahar Hosseinzadeh
NICU, Dr pirooz hospital, Keshavarz Blvd
Lahijan Iran (Islamic Republic of) 43111-44199 +98 13 4223 5503 sahar.hosseinzadeh@ymail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) For mothers, entry conditions include: no history of infertility Uncomplicated pregnancy Desire to be pregnant No history of physical and mental illness No addiction Lack of accidents during the last three months (according to the participant) The conditions for the inclusion of infants in the study include: 1) infants with a gestational age of 29-34 weeks, 2) having physiological stability and no stress symptoms at the time of stimulation, 3) without cleft palate, cleft lip, and temperament abnormalities, 4) infants with an Apgar score of 5 or more than 7 no limit no limit Female Mother's unwillingness to continue participating in the study Early discharge of the baby with the personal consent of the parents Transferring the baby to another treatment center Not having the ability to intervene Incompleteness of 20% of the completed information of the forms The conditions for the exclusion of infants from the study: 1) sepsis 2) heart disease 3) necrotizing enterocolitis 4) grade 3 and 4 intraventricular hemorrhage (according to sonography that is routinely performed in the first week) 5) severe asphyxia Rehabilitation N/A Intervention group: The mood questionnaire will be filled in at the beginning of the study by the mother, who both herself and her baby meet the inclusion criteria. And oral motor intervention of the premature baby is taught to the mother by the researcher on the doll and educational videos. Then, after appropriate feedback, this intervention will be performed by the mother on her baby under the supervision of the researcher and speech therapy for 10 days. And the mood questionnaire will be completed again by the mother after 10 days of intervention. Control group: The mood questionnaire will be completed at the beginning of the study by mothers who both themselves and their babies meet the entry criteria. And 10 days later, this questionnaire is filled again by mothers. During these 10 days, the baby will be cared for according to the department's routine. Mood score in POMS standard questionnaire. Timepoint: Measuring the mood score at the beginning of the study (before the intervention) and 10 days after the intervention. Method of measurement: Standard Mood Questionnaire (POMS). Participation. Timepoint: The questionnaire will be filled at the beginning of the study and 10 days later. Method of measurement: Questionnaire POMS. Tehran University of Medical Sciences Approved 2023-04-16 Working Group / Ethics Committee in Research Faculty of Nursing, Midwifery and Rehabilitation Facult Dr. Mirkhani St (East Nusrat), Tawheed Square Tehran Tehran Iran (Islamic Republic of)