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IRCT20170506033834N11 IRCT 2023-08-20 Tabriz University of Medical Sciences Comparison of the effect of in-home and phone supportive counseling on postpartum depression and anxiety: a randomized controlled clinical trial Comparison of the effect of in-home and phone supportive counseling on postpartum depression and anxiety: a randomized controlled clinical trial 2023-09-06 anticipated 93 Complete https://irct.ir/trial/71775 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants were divided into two intervention groups (recipients of supportive counseling at home and supportive counseling over the phone) and a control group (recipients of routine care after delivery) will be allocated. For concealment, the type of allocation will be written on paper and placed in numbered opaque envelopes (Allocation Concealment). The envelopes will be opened in order and by a person not involved in sampling, Blinding description: In this study, according to the nature of the study, it will not be possible to blind the participants and the researcher, and only the evaluator of the results will be a blind person. N/A Postpartum. Intervention 1: Intervention group: In one of the intervention groups, supportive counseling will be done at home during three sessions on days 5-3 7-9 and 20-25 after delivery for 30-45 minutes .The content of the counseling sessions according to the support counseling protocol will be as follows: The first session (3-5 days after delivery): includes encouraging to talk about the questions and problems that the person has in the process of self-care and caring for the baby and about breastfeeding. Also, criteria of sufficient amount of breast milk, the reasons of infants' crying and refusing to take the breast, nutrition of mothers during breastfeeding, methods to increase breast milk, breast problems, constipation, back pain, care of episiotomy sutures and pain management, and care of the baby's umbilical cord will be explained. The second session (7-9 days after delivery): in this session, in relation to how to store milk and continue breastfeeding, fatigue and the matching of sleeping and waking time with the baby, how the mother interacts with the child, perceived supports, self-care and coping with the responsibilities will be explained. The purpose of this meeting is to recount the person's emotional-emotional reactions to the new situation, and the counselor is looking for performance disturbances, signs such as stress and wrong adaption to explain how to deal with it (teaching relaxation techniques, seeking and attracting social support, improving communication skills with others and especially with husbands). The third session (20-25 days after delivery): in this session, we will talk about the time to resume sexual relations, and contraception methods in breastfeeding mothers and the continuation of breastfeeding. Relaxation techniques will be reviewed and summarized the session details. Intervention 2: Intervention group: In the other intervention group, phone support counseling will be done in three sessions on days 9-9, 7-3 and 20-25 after delivery for 30-45 minutes. The content of this type of counseling will be the same as home support counseling. If the client needs, one more meeting will be held in each of the groups with prior coordination of the clients. The counseling time will be determined according to the previous agreement with the participants. Intervention 3: Control group: In this study, the control group will receive only the usual care after delivery. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more data
public bita eskandari
Faculty of Nursing and Midwifery, South Shariati, Tabriz
Tabriz Iran (Islamic Republic of) 5313644351 +98 41 3479 6770 bitaeskandari7250@gmail.com Tabriz University of Medical Sciences scientific Dr. Roghaiyeh Nourizadeh
Faculty of Nursing and Midwifery, South Shariati St., Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 nourizadehr@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Primiparous women by vaginal method Having a desire to breastfeed Age 18-45 Living in Tabriz Single birth Mothers with term babies weighing 2500 to 4000 grams 18 years 45 years Female Mothers with hospitalized babies. Existence of systemic and chronic diseases or aggravating disorders during pregnancy and childbirth, including gestational or overt diabetes, blood pressure disorders, heart disease, and the inability of the mother to care for the baby. Breast anomaly or history of breast surgery The existence of unfortunate events in the last three months, including the death of loved ones, divorce, etc. Obtaining a depression score of 13 or more based on the Edinburgh postpartum depression scale Depressive disorders before pregnancy and delivery according to mother's statement Cases of malformation and infant death Excessive bleeding during childbirth Having breast-feeding contraindications (women undergoing chemotherapy, women with HIV infection, women with untreated active tuberculosis, and the use of radioactive, antimetabolite and illegal drugs during breastfeeding such as methotrexate, mercaptopurine, hydroxyurea, tamoxifen, bromocriptine, Lithium, phenin-dione, phen-cyclidine, cyclophosphamide and doxorubicin, drugs and... Encounter Z39 Behavior Behavior Behavior Intervention group: In one of the intervention groups, supportive counseling will be done at home during three sessions on days 5-3 7-9 and 20-25 after delivery for 30-45 minutes .The content of the counseling sessions according to the support counseling protocol will be as follows: The first session (3-5 days after delivery): includes encouraging to talk about the questions and problems that the person has in the process of self-care and caring for the baby and about breastfeeding. Also, criteria of sufficient amount of breast milk, the reasons of infants' crying and refusing to take the breast, nutrition of mothers during breastfeeding, methods to increase breast milk, breast problems, constipation, back pain, care of episiotomy sutures and pain management, and care of the baby's umbilical cord will be explained. The second session (7-9 days after delivery): in this session, in relation to how to store milk and continue breastfeeding, fatigue and the matching of sleeping and waking time with the baby, how the mother interacts with the child, perceived supports, self-care and coping with the responsibilities will be explained. The purpose of this meeting is to recount the person's emotional-emotional reactions to the new situation, and the counselor is looking for performance disturbances, signs such as stress and wrong adaption to explain how to deal with it (teaching relaxation techniques, seeking and attracting social support, improving communication skills with others and especially with husbands). The third session (20-25 days after delivery): in this session, we will talk about the time to resume sexual relations, and contraception methods in breastfeeding mothers and the continuation of breastfeeding. Relaxation techniques will be reviewed and summarized the session details. Intervention group: In the other intervention group, phone support counseling will be done in three sessions on days 9-9, 7-3 and 20-25 after delivery for 30-45 minutes. The content of this type of counseling will be the same as home support counseling. If the client needs, one more meeting will be held in each of the groups with prior coordination of the clients. The counseling time will be determined according to the previous agreement with the participants. Control group: In this study, the control group will receive only the usual care after delivery. Postpartum Depression. Timepoint: 10-15 days and 42-60 days after delivery by controlling the effect of baseline score. Method of measurement: Edinburgs Postpartum Depression Scale. Specific postpartum anxiety. Timepoint: 10-15 days and 42-60 days after delivery by controlling the effect of baseline score. Method of measurement: PSAS-RSF(Postpartum Specific Anxiety Scale Research short-form). Quality of life of mothers. Timepoint: 10-15 days after delivery. Method of measurement: MAPP-QOL(Maternal Postpartum Quality). Frequency of exclusive breastfeeding. Timepoint: 42-60 days after birth. Method of measurement: A checklist designed to record breastfeeding status. Comparison of infant weight. Timepoint: One month after giving birth. Method of measurement: Baby weight card. Comparison of the frequency of newborn visits by doctors. Timepoint: 42-60 days after birth. Method of measurement: Checklist designed to record the number of baby visits by the doctor. Tabriz University of Medical Sciences Approved 2023-08-12 Ethics Commite of Tabriz University of Medical Sciences Golgasht St., Tabriz University of Medical Sciences, Faculty of Dentistry Tabriz East Azarbaijan Iran (Islamic Republic of)