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IRCT20150713023190N8 IRCT 2019-01-20 Rafsanjan University of Medical Sciences Investigating the effect of auriculotherapy on shoulder pain after cesarean section Investigating the effect of auriculotherapy on shoulder pain after cesarean section in pregnant women referring to medical educational centers of Rafsanjan University of medical sciences 2019-01-21 anticipated 90 Complete https://irct.ir/trial/36298 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Stratified randomization by minimization method: in this method, initially, the patients will categorize based on key variables, such as history of cesarean section and number of deliveries. Afterwards, from the patients who will meet the inclusion criteria, the first participant will place in the intervention or control group by coin flip, and other participants will allocate to the study group with lower total of variables, Blinding description: The patient will not know that he/she is in the intervention group or control. The earrings will be placed on the ears by someone other than the researcher and the researcher will not be aware of the intervention and control groups. The analyzer will not know the intervention and control groups. N/A Cesarean. Intervention 1: Intervention group: in this group, earrings (two hours before surgery for up to 24 hours after surgery), will be placed on the shoulder and muscle relaxation points on both ears. Intervention 2: Control group: in this group, in the same time period (two hours before surgery for up to 24 hours after surgery), earrings will be placed on the placebo points on both ears. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of data
public Maryam Abedini
Parastar Ave
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 abedini.maryam1973@gmail.com Rafsanjan University of Medical Sciences scientific Tabandeh Sadeghi
Parastar Ave
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 t.b_sadeghi@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Inform consent for participation in the study Age between 18 to 40 years Gestational age more than 36 weeks Healthy points on the ear to put the earrings 18 years 40 years Both Contraindication for spinal anesthesia; Addiction; Using tranquilizer drugs before the surgery; Fracture or dislocation of shoulder; Chronic pain of shoulder or neck; History of shoulder trauma; History of mental illness; History of any abdominal surgery other than cesarean section. 082 Single delivery by cesarean section Prevention N/A Intervention group: in this group, earrings (two hours before surgery for up to 24 hours after surgery), will be placed on the shoulder and muscle relaxation points on both ears. Control group: in this group, in the same time period (two hours before surgery for up to 24 hours after surgery), earrings will be placed on the placebo points on both ears. Score of shoulder pain using numerical pain rating scale. Timepoint: 1, 6 and 24 hour after cesarean section. Method of measurement: Numerical pain rating scale. Rafsanjan University of Medical Sciences Approved 2018-12-23 Ethics committe of Rafsanjan University of Medical Sciences Imam Ali Blvd Rafsanjan Kerman Iran (Islamic Republic of)