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IRCT20180218038789N2 IRCT 2020-06-19 Qazvin University of Medical Sciences Investigating the effect of ear acupressure on postpartum blues Investigating the effect of ear acupressure on postpartum blues: A randomized sham controlled trial 2020-07-05 anticipated 74 Complete https://irct.ir/trial/48987 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random allocation will be done using balanced block randomization methods with each block size of 4. The allocation sequence will be generated using online software. After preparing the allocation sequence, the sequence will be written down on paper in order and placed inside the closed sealed envelopes. Envelopes are numbered sequentially. Questionnaires are coded in the same way. Accordingly, each person will be assigned to one of the intervention or control groups, Blinding description: In this study, the control group will receive the same intervention as the main group ( sham control). Therefore, participants will not know what group they are in. Since the clinical caregiver and the outcome assessor and data analyst are not aware of this, blindness of the second and third levels will also be implemented. N/A Postpartum blues. Intervention 1: Intervention group: Auriculotherapy. Intervention 2: Control group: Sham control. Yes - There is a plan to make this available What will be shared: The data related to the study will be published as an anonymous and unrecognizable file at the same time as the publication of the results as an appendix. When: After the publication of the article, the results of the data design will be available To whom: All people can access the data by referring to the appendix of published article Conditions: All people with no limitation can access data Where to obtain: Appendix of published article How to obtain: Email to corresponding author Comments:
public Zainab Alimoradi
Bahonar Blouvard, Qazvin University of Medical Sciences, School of Nursing and Midwifery
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3333 8034 zainabalimoradi.sbmu.ac.ir@gmail.com Qazvin University of Medical Sciences scientific Zainab Alimoradi
Bahonar Blouvard, Qazvin University of Medical Sciences, School of Nursing & Midwifery
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3333 8034 zainabalimoradi.sbmu.ac.ir@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) The desire to participate in the study Being primiparous Born a full term, singleton baby Having a healthy earlobe with no lesions, sores and pain in the earlobe Being Iranian Being literate at least with ability in reading and writing Availability during the study period (residence in Qazvin city) no limit no limit Female Complications in pregnancy and postpartum (e.g. preterm delivery, preeclampsia, gestational diabetes, ‌ infant in need of special care, etc.) History of chronic mental and physical illness (self-report and review of the individual's file) Drug abuse in the individual or his spouse History of acupressure in the last three months History of stressful events in the last three months (such as the loss of loved ones) Prevention Prevention Intervention group: Auriculotherapy Control group: Sham control Intensity of postpartum blues. Timepoint: pre-intervention, 5 , 10 , 15 days after intervention. Method of measurement: Maternity Blues Questionnaire. Intensity of postpartum tiredness. Timepoint: pre- intervention, 5, 10, 15 , 21 days after intervention. Method of measurement: Iowa tiredness scale. Maternal attachment. Timepoint: pre- intervention, 5, 10, 15 , 21 days after intervention. Method of measurement: Muller Maternal Attachment Index. Intensity of postpartum depression. Timepoint: 21 days after intervention. Method of measurement: Edinburgh Postnatal Depression scale. Qazvin University of Medical Sciences Approved 2020-05-20 Ethics committee of Qazvin University of Medical Sciences Shahid Bahonar Boulevard Qazvin Qazvin Iran (Islamic Republic of)