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IRCT20171102037187N2 IRCT 2018-02-23 Mashhad University of Medical Sciences The effect of a maternal, educational, supportive and care program on treatment of infantile colic pain The effect of a maternal, educational, supportive and care program on sleeping, pain and crying rate due to colic in 1-5 months infants 2018-01-29 anticipated 88 Complete https://irct.ir/trial/27571 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: At the start of the intervention and in a briefing session, a case study and one-person-care counseling program will be provided to the case group and a training booklet will be provided, Randomization description: All referrers who come to the colic during the winter to spring are invited to study using available samples. Examples that appear on odd days are part of the control group. Examples that go on even days are part of the intervention group, Blinding description: In this study, all participants are informed on the basis of informed consent and are unaware of the allocation of the groups. And the main seeker who seeks to respond to the research hypothesis is unaware of the outcome of the study. N/A infants colic. Intervention 1: In the case of infants who suffer from colic and have their colic approved by the doctor and are among the criteria for entering the study, parents are informed by written consent. Intervention 2: Control group:In the control group, probiotic drops are prescribed by the doctor, and the doctor will instruct the doctor how to give it to the infant by the researcher. Telling mothers about how to complete the registration (length of crying, infant crying, 24-hour sleep, and lactating sleep), as well as the breastfeeding model, maternal and infant's demographic information, and maternal nutritional information, by the researcher upon entering the study Is taught. For 8 days, complete the checklist based on the criteria for the pain cache for the severity of the cry and the hours for the infant. On the eighth day after the referral to the clinic, the checklist is delivered to the researcher. Intervention 3: Intervention group: In the intervention group, at a briefing session, a tutorial-support-care program for 30 minutes in person and one-to-one and giving a training booklet and giving the drops of probiotics prescribed by the doctor and how to give it to the infant. Telling mothers about how to complete the registration (length of crying, infant crying, 24-hour sleep, and lactating sleep), as well as the breastfeeding model, maternal and infant's demographic information, and maternal nutritional information, by the researcher upon entering the study Will be taught. For 8 days, they will run an educational-support-care program and within these 8 days, mothers will complete their checklist based on the criteria for pain relief for severity of crying and hours for infancy. On the eighth day after the referral to the clinic, the checklist is delivered to the researcher. Yes - There is a plan to make this available What will be shared: Only part of the data, such as the information on the main outcome, can be shared. When: "Starting the access period from 1397" To whom: It will be available to researchers working in academic and scientific institutions and industry professionals. Conditions: Based on the diagnostic criteria of Wessel, crying healthy infants for more than 3 hours a day, for 3 days a week, and in 3 consecutive weeks, they are called colic of infancy. Where to obtain: This study is a clinical trial study with 5% lower weight in the intervention group. Infants whose crying hours dropped between 1-2 hours a day would decrease as more than 2 hours as relative responders as full responders, and those whose crying hours are unaltered as non-response. How to obtain: 2 months approval of the design and approval of the Ethics Committee, 3 months of sampling and intervention, writing of the first and third seasons, 1 month of data recording and statistical analysis, 2 months arranging and finalizing the fourth and fifth chapters, typing and replicating, preparing and accepting the article. Comments:
public Tahereh Sadeghi
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Ph.D., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 SadeghiT@mums.ac.ir Mashhad University of Medical Sciences scientific Tahereh Sadeghi
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Ph.D., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 SadeghiT@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Have exclusive breastfeeding. Between 1 and 5 months. The infant has no autoimmune congenital or nutritional problem. At birth, the term of birth is more than 2500 grams. Appropriate weighing of the infant at that age is based on the percentile in the normal range. No skin lesions in breastfeeding and maternity. 30 days 5 months Both Good poor feeding. Use of chemical drugs such as anti-pneumonia and ... at the time of the intervention. The child has a history of surgery and swelling. Exclusion of exclusive breastfeeding. The child now has an acute illness, such as a cold, etc. R10.4 R10.4 Other and unspecified abdominal pain. Abdominal tenderness NOS Colic: NOS infantile Prevention Treatment - Drugs Prevention In the case of infants who suffer from colic and have their colic approved by the doctor and are among the criteria for entering the study, parents are informed by written consent. Control group:In the control group, probiotic drops are prescribed by the doctor, and the doctor will instruct the doctor how to give it to the infant by the researcher. Telling mothers about how to complete the registration (length of crying, infant crying, 24-hour sleep, and lactating sleep), as well as the breastfeeding model, maternal and infant's demographic information, and maternal nutritional information, by the researcher upon entering the study Is taught. For 8 days, complete the checklist based on the criteria for the pain cache for the severity of the cry and the hours for the infant. On the eighth day after the referral to the clinic, the checklist is delivered to the researcher. Intervention group: In the intervention group, at a briefing session, a tutorial-support-care program for 30 minutes in person and one-to-one and giving a training booklet and giving the drops of probiotics prescribed by the doctor and how to give it to the infant. Telling mothers about how to complete the registration (length of crying, infant crying, 24-hour sleep, and lactating sleep), as well as the breastfeeding model, maternal and infant's demographic information, and maternal nutritional information, by the researcher upon entering the study Will be taught. For 8 days, they will run an educational-support-care program and within these 8 days, mothers will complete their checklist based on the criteria for pain relief for severity of crying and hours for infancy. On the eighth day after the referral to the clinic, the checklist is delivered to the researcher. Pain colic in infants. Timepoint: The severity of colic symptoms in infants before and after intervention in each group is calculated on the third and seventh day of treatment, and each group will be compared on the third and the third day of treatment separately from before intervention (due to taking the third day of treatment, the mean of the treatment for the infant and the day Seventh is the end of intervention treatment). Method of measurement: In both groups, mothers will complete the checklist based on the criteria for pain relief for severity of crying and hours for infant.The questionnaire includes a tool for evaluating colic pain, Visual Analogue Scale. The amount of colic pain, infant crying, the frequency of crying, the duration of infancy and the severity of infant crying. Timepoint: Weekly (as the basal stage) record the infant's cry and sleep at night. In the second stage (as an intervention stage), mothers will be advised to run an educational-support-care program for a period of 8 days. Method of measurement: A researcher-made instrument that has four parts: maternal and infant characteristics, and breastfeeding pattern, maternal nutritional instrument, incubation colic assay (the main tool for the dependent variables), Visual Analogue Scale, including the duration of crying and its frequency in 24 Hours is. Mashhad University of Medical Sciences Approved 2018-01-12 Medical Ethics Committee Faculty of Nursing and Midwifery, Ibn Sina Avenue, Ph.D., Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)