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IRCT20210607051505N1 IRCT 2021-06-23 Vice Chancellor of Guilan University of Medical Sciences Evaluation the Effect of Auriculotherapy on Post-Cesarean Section Anxiety Evaluation the Effect of Auriculotherapy on Post-Cesarean Section Anxiety in women admitted to the postpartum ward 2021-07-10 anticipated 66 Complete https://irct.ir/trial/56757 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The type of randomization is blocking and will be divided into two groups of Auriculotherapy and control using the block randomization method with the size of 4 and 6 blocks. The method used to generate the random allocation sequence is from the online randomization service Sealed Envelope Ltd. 2019 will be used (https://www.sealedenvelope.com/simple-randomiser/v1/lists) The method of concealing the allocation is to use sealed envelopes. N/A Anxiety. Intervention 1: Intervention group: 2 times Auriculotherapy on the first day and 2 times an intervention on the second day after cesarean section / Vacaria herbal seeds will be pasted in 6 points related to anxiety / Continuation of Auriculotherapy every hour for one minute to ten days after cesarean section. Intervention 2: Control group: no intervention / Routine postpartum care is provided. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After sampling
public Somayeh Sharifi Pirjel
Daneshjoo St., Rasht - Shahid Beheshti Highway, Rasht Town
Rasht Iran (Islamic Republic of) 39841-41469 +98 13 3355 5056 som.sharifi@gmail.com Guilan University of Medical Sciences scientific Niknami Maryam
Daneshjoo St., Shahid Beheshti Highway, Rasht Town
Rasht Iran (Islamic Republic of) 39841-41469 +98 13 3355 5056 niknami@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Signing informed written consent Having minimum literacy rate Term and singleton pregnancy Having healthy neonate no limit no limit Female Speech, hearing or mental problems that prevent communication with the researcher Medical and obstetric disorders Migraines Starting labor pain History of Auriculotherapy Sores, cysts or moles on the ears Smoking, hookah, alcohol and sedatives Intense emotional excitement of the mother in the last 6 months, including: separation from her husband, loss of a family member, accidents or unfortunate events for herself or a loved one Emergency caesarean section People who have had unsuccessful spinal anesthesia followed by general anesthesia F41.8 Other specified anxiety disorders Treatment - Other Other Intervention group: 2 times Auriculotherapy on the first day and 2 times an intervention on the second day after cesarean section / Vacaria herbal seeds will be pasted in 6 points related to anxiety / Continuation of Auriculotherapy every hour for one minute to ten days after cesarean section Control group: no intervention / Routine postpartum care is provided State and trait anxiety scores in the Spielberg er questionnaire. Timepoint: Before the intervention, 2 and 10 days after the intervention. Method of measurement: The method of measuring the anxiety outcome variable is the Spielberg er overt and covert anxiety questionnaire. This tool contains 40 items, 20 of which are related to overt anxiety and 20 items are related to latent anxiety. Vice Chancellor of Guilan University of Medical Sciences Approved 2021-06-01 Ethics Committee of Guilan University of Medical Sciences Daneshjoo St, Rasht - Shahid Beheshti Highway, Rasht Town Rasht Guilan Iran (Islamic Republic of)