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IRCT20250907067159N1 IRCT 2025-12-07 Tabriz University of Medical Sciences Effect of Supportive Counseling With and Without Auriculotherapy on Postpartum Stress and Anxiety Comparison of the Effects of Supportive Counseling With and Without Auriculotherapy on Postpartum Stress and Anxiety 2025-12-22 anticipated 78 Complete https://irct.ir/trial/87095 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be performed using a stratified block randomization method. The unit of randomization is the individual mother. Stratification will be based on type of delivery (vaginal/cesarean) and parity (primiparous/multiparous) to ensure balanced baseline characteristics. The random allocation sequence will be generated using variable block sizes of 3 and 6 by an independent person through Random Allocation Software. For allocation concealment, the group codes will be placed in opaque, sealed, and sequentially numbered envelopes, opened in order by a person not involved in the study. Participants will be randomly assigned to one of three groups: supportive counseling, supportive counseling with auricular acupressure, or routine postpartum care. N/A Postpartum Anxiety. Intervention 1: Intervention group: In one of the intervention groups, supportive counseling will be conducted in person over three sessions on days 10–15, 15–22, and 30 postpartum, each lasting 30–45 minutes. The content of the counseling sessions, based on the supportive counseling protocol, is as follows:Session 1 (10–15 days postpartum):This session includes an introduction, taking a medical and psychological history, discussing the rules, conditions, and goals of the counseling process, and encouraging the mother to express any questions and concerns that cause stress and anxiety during the postpartum period. The session also focuses on exploring the mother’s emotional and psychological reactions to her new situation. The counselor looks for signs of functional disruption, stress symptoms, and maladaptive coping strategies in order to identify the mother’s adaptive strengths and weaknesses. This allows the counselor to explain appropriate coping methods (such as relaxation techniques, seeking and mobilizing social support, and improving communication skills—particularly with the spouse).Additionally, the session provides education on adequate breast milk supply, reasons for infant crying and refusal to breastfeed, neonatal danger signs, vomiting and aspiration, neonatal jaundice, maternal nutrition during breastfeeding and strategies to increase milk production, breast problems, constipation, postpartum bleeding, back pain, episiotomy wound care, pain management, and umbilical cord care.Session 2 (15–22 days postpartum):In this session, the mother’s physical and psychological experiences are reviewed, and signs of stress and anxiety are assessed. Relaxation techniques and coping skills are revisited, with an emphasis on the role of social support. Practical, individualized strategies for managing stress and anxiety are also provided.Session 3 (30 days postpartum):At this stage, the mother’s progress in using psychological coping skills is evaluated. Questions are addressed, and additional recommendations are offered. Intervention 2: Intervention group: In the other intervention group, supportive counseling combined with auriculotherapy will be conducted in person over three sessions on days 10–15, 15–22, and 30 postpartum, each lasting 30–45 minutes. The content of the counseling sessions is identical to that of the first intervention group.Session 1:Alongside supportive counseling, Vaccaria seeds will be applied to specific points on the auricle. The selected points include Shen Men, Anxiety, and Mammary Gland 1 & 2 on the left ear, and Thalamic, Master Shoulder, Cerebral, and Lung 1 & 2 on the right ear. The mother will be instructed on how to stimulate these points: she should gently apply pressure to each point for one minute, 5–6 times a day.Session 2:In addition to supportive counseling, the auriculotherapy seeds will be replaced, and the same points will be stimulated again.Session 3:During this session, the auriculotherapy seeds will once again be replaced and the same points stimulated. The counselor will also assess whether the mother has been correctly stimulating the ear points and evaluate the extent of their effectiveness. 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 It is confidential.
public Zahra Omranian Esfahani
Faculty of Nursing and Midwifery, South Shariati, Tabriz
Tabriz Iran (Islamic Republic of) 5313644351 +98 41 3479 6770 z.omranian@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) Iran (Islamic Republic of) Women aged 18–49 years Willingness to breastfeed their infants Residence in Tabriz Singleton delivery Mothers with term neonates weighing 2,500–4,000 grams Mothers with a stress score higher than 14–26 and a moderate anxiety score of 32–50 (above the mean score according to the Angoff method) 18 years 49 years Female Mothers with hospitalized neonates Presence of systemic or chronic diseases or conditions exacerbated during pregnancy or postpartum, including gestational or overt diabetes, hypertensive disorders, cardiac diseases, or inability to care for the newborn Experience of major adverse life events during the past three months, such as death of first-degree relatives or divorce History of psychiatric disorders or use of antidepressant or antipsychotic medications, based on the mother’s self-report Unplanned pregnancies, fetal abnormalities, hypothyroidism, or neonatal death Mothers with breast anomalies, history of breast surgery, or contraindications to breastfeeding, including: • Women under chemotherapy. • Women with HIV infection or untreated active tuberculosis. • Women using radioactive drugs, antimetabolites, or contraindicated medications during lactation, such as methotrexate, mercaptopurine, hydroxyurea, tamoxifen, bromocriptine, lithium, phenindione, phencyclidine, cyclophosphamide, and doxorubicin, as well as illicit drug use The Edinburgs Depression Score of 13 or higher F41 Other anxiety disorders Behavior Treatment - Devices Behavior Intervention group: In one of the intervention groups, supportive counseling will be conducted in person over three sessions on days 10–15, 15–22, and 30 postpartum, each lasting 30–45 minutes. The content of the counseling sessions, based on the supportive counseling protocol, is as follows:Session 1 (10–15 days postpartum):This session includes an introduction, taking a medical and psychological history, discussing the rules, conditions, and goals of the counseling process, and encouraging the mother to express any questions and concerns that cause stress and anxiety during the postpartum period. The session also focuses on exploring the mother’s emotional and psychological reactions to her new situation. The counselor looks for signs of functional disruption, stress symptoms, and maladaptive coping strategies in order to identify the mother’s adaptive strengths and weaknesses. This allows the counselor to explain appropriate coping methods (such as relaxation techniques, seeking and mobilizing social support, and improving communication skills—particularly with the spouse).Additionally, the session provides education on adequate breast milk supply, reasons for infant crying and refusal to breastfeed, neonatal danger signs, vomiting and aspiration, neonatal jaundice, maternal nutrition during breastfeeding and strategies to increase milk production, breast problems, constipation, postpartum bleeding, back pain, episiotomy wound care, pain management, and umbilical cord care.Session 2 (15–22 days postpartum):In this session, the mother’s physical and psychological experiences are reviewed, and signs of stress and anxiety are assessed. Relaxation techniques and coping skills are revisited, with an emphasis on the role of social support. Practical, individualized strategies for managing stress and anxiety are also provided.Session 3 (30 days postpartum):At this stage, the mother’s progress in using psychological coping skills is evaluated. Questions are addressed, and additional recommendations are offered. Intervention group: In the other intervention group, supportive counseling combined with auriculotherapy will be conducted in person over three sessions on days 10–15, 15–22, and 30 postpartum, each lasting 30–45 minutes. The content of the counseling sessions is identical to that of the first intervention group.Session 1:Alongside supportive counseling, Vaccaria seeds will be applied to specific points on the auricle. The selected points include Shen Men, Anxiety, and Mammary Gland 1 & 2 on the left ear, and Thalamic, Master Shoulder, Cerebral, and Lung 1 & 2 on the right ear. The mother will be instructed on how to stimulate these points: she should gently apply pressure to each point for one minute, 5–6 times a day.Session 2:In addition to supportive counseling, the auriculotherapy seeds will be replaced, and the same points will be stimulated again.Session 3:During this session, the auriculotherapy seeds will once again be replaced and the same points stimulated. The counselor will also assess whether the mother has been correctly stimulating the ear points and evaluate the extent of their effectiveness. Control group: In this study, the control group will receive only the usual care after delivery. Postpartum stress. Timepoint: one and two month after delivery by controlling the effect of baseline score. Method of measurement: Perceived Stress Scale. Specific postpartum anxiety. Timepoint: one and two month after delivery by controlling the effect of baseline score. Method of measurement: PSAS-RSF(Postpartum Specific Anxiety Scale Research short-form). Postpartum Depression. Timepoint: one and two month after delivery by controlling the effect of baseline score. Method of measurement: Edinburgs Postpartum Depression Scale. Frequency of exclusive breastfeeding. Timepoint: one and two month after delivery. Method of measurement: A checklist designed to record breastfeeding status. Comparison of the frequency of newborn visits by doctors. Timepoint: one and two month after delivery. Method of measurement: Checklist designed to record the number of baby visits by the doctor. Tabriz University of Medical Sciences Approved 2025-12-03 Ethics Committee of Tabriz University of Medical Sciences Freedom Street, Golgasht Street, Tabriz University of Medical Sciences, Central Building No. 2, Third Floor, Research Vice-Chancellor's Office. Tabriz East Azarbaijan Iran (Islamic Republic of)