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

Determination the effect of auriculotherapy on shoulder pain after cesarean section in pregnant women referring to medical educational centers of Rafsanjan University of medical sciences

Two arm parallel groups (45 person in each groups), three blinded clinical randomized trial

In this clinical trial, participants will be selected by convenience sampling method. Random allocation will be done by minimization method based on the number of delivery and history of cesarean section to the two groups of control and intervention. In the intervention group, the 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. In the control 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. Then, one hour after surgery, 6 and 24 hours after surgery, in both groups, shoulder pain will be assessed using a numerical pain rating scale.

Inform consent for participation in the study, age between 18 to 40 years, gestational age more than 36 weeks and healthy points on the ear to put the earrings are the inclusion criteria. 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 and history of any abdominal surgery other than cesarean section are exclusion criteria.

Intervention 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: earrings (two hours before surgery for up to 24 hours after surgery) will be placed on the placebo points on both ears.

Shoulder pain

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.

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.

Confidentiality of data