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IRCT20171224038034N1 IRCT 2018-02-17 Sanandaj University of Medical Sciences Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in post-episiotomy pain Effect of Transcutaneous electrical nerve stimulatio (TENS) in post-episiotomy pain 2018-04-20 anticipated 80 Complete https://irct.ir/trial/28481 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using Blocked Randomization for randomization, Blinding description: Samples of their belonging to a control group or the intervention are unaware and pain evaluation by a research associate, that unaware of the Belonging to the intervention group or control people will be done. N/A Pain after episiotomy. Intervention 1: Intervention group:The transcutaneous electrical nerve stimulation electrodes, 6-24 hours after episiotomy, will be insert in parallel, near the episiotomy, in the region of the pudendal and genitofemoral nerve and device will be on for 60 minutes, after that pain will be assessed again during four specific time: before applying TENS, 30 minutes, 60 minutes and 120 minutes after removing TENS, at rest and activity (sitting and walking). Intervention 2: Control group: In this group electrodes will be insert at the same place as intervention group but device will be off and the evaluation is as the same. 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 I do not have any plans yet
public Seyedeh Soma Zakaryaee
Kurdistan University of Medical Sciences, Pasdaran street, Sanandaj
Sanandaj Iran (Islamic Republic of) 66166 +98 87 3366 1120 ss.zakaryaee@gmail.com Sanandaj University of Medical Sciences scientific Seyedeh Soma Zakaryaee
Kurdistan University of Medical Sciences, Pasdaran street, Sanandaj
Sanandaj Iran (Islamic Republic of) 66166 +98 87 3366 1120 ss.zakaryaee@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Nulliparous low-risk pregnancy Singleton pregnancy Gestational age 42-38 weeks spontaneous vaginal delivery ( without use of vacuum and forceps) with mediolateral episiotomy presenting pain in the episiotomy area (pain score 4 or more) no use of analgesics during data collection no limit no limit Female side effects of TENS (burns, wounds, skin allergy) Not having epilepsy and mental illness Not having heart pacemaker and heart disease G89.18 Other acute postprocedural pain N/A Treatment - Drugs Intervention group:The transcutaneous electrical nerve stimulation electrodes, 6-24 hours after episiotomy, will be insert in parallel, near the episiotomy, in the region of the pudendal and genitofemoral nerve and device will be on for 60 minutes, after that pain will be assessed again during four specific time: before applying TENS, 30 minutes, 60 minutes and 120 minutes after removing TENS, at rest and activity (sitting and walking). Control group: In this group electrodes will be insert at the same place as intervention group but device will be off and the evaluation is as the same. Pain severity after episiotomy. Timepoint: evaluating pain severity in before applying TENS, 30 minutes, 60 minutes and 120 minutes after removing TENS, at rest and activity (sitting and walking). Method of measurement: NRS. Sanandaj University of Medical Sciences Approved 2018-02-04 Ethic committee of Kurdistan University of Medical Sciences Kurdistan University of Medical Sciences , Pasdaran Street, Sanandaj Sanandaj Kurdistan Iran (Islamic Republic of) Approved 2018-02-18 Ethic committee of Kurdistan University of Medical Sciences Kurdistan University of Medical Sciences , Pasdaran Street, Sanandaj Sanandaj Kurdistan Iran (Islamic Republic of)