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IRCT20140811018760N5 IRCT 2019-08-16 Tabriz University of Medical Sciences The effects of trans-cutaneous electrical stimulation on labor pain The effects of trans-cutaneous electrical nerve stimulation ( Interferential current (IFC))in comparison with sham IFC on labor pain among nulliparous women 2019-09-23 anticipated 60 Complete https://irct.ir/trial/39488 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Pregnant women who are at the start of active phase of labor (4 cm dilatation), if appropriate, were randomly assigned random block sizes of 4 and 6 blocks with a 1: 1 ratio in The two groups will intervention and control. For the Allocation Concealment, the type of intervention received is written on a piece of paper and placed inside the opaque envelopes, the back of the file will be numbered. The envelopes will be opened according to the entry of the participants and the type of group will be specified, Blinding description: Participants in this study will be blind in which group they are ,also the investigator(data assessor) will be blind about the individuals in the intervention or control group. And the data analyzer will be blind about data is related to the control group, or the intervention. N/A labor. Intervention 1: Intervention group: In this group, 30 to 45 minutes of electrical stimulation were obtained using a multistimulator (X735 Novin medical engineering company) at the start of the active phase (reaching the cervical dilatation of 4 cm in high electrodes and 30 to 45 minutes late in the active phase( cervical dilatation of 8 to 10 cm) will be applied at lower electrodes with a base frequency of 4000 Hz , a beat frequency of 80 to 120 Hz and pulse duration of 50 to 60 microseconds, in addition to routine care. Intervention 2: Control group: They will be treated as a placebo group and the electrodes are similar to the intervention group and will be operated in the same phase with the intervention group, only the output of the device will be zero.  Both groups will receive routine care that includes checking vital signs of the mother and the fetus, the condition of the fetues, the status of the pouch, the need for oxytocin and medication. Yes - There is a plan to make this available What will be shared: In case of IPD, participant data sets could be shared When: Starting 6 months after publication To whom: Only available for people working in academic institutions in Iran Conditions: In case of journal or reviewers request for data set Where to obtain: Via email and giving documents to prove their identity How to obtain: Sending email and documents to prove their identity Comments:
public Fariba Ghaderi
Rehabilitation Faculty, Daneshgah Ave., Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5167631444 +98 41 3334 5121 ghaderif@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Fariba Ghaderi
Rehabilitation Faculty, Daneshgah Ave., Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5167631444 +98 41 3334 5121 ghaderif@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Primiparity one fetus Gestational age 37 -42 Early stage of active phase(dilation 4cm) Cephalic presentation of fetus 20 years 45 years Female mother heart disease mother Diabetes mother High blood pressure Pre-eclampsia HELP syndrome Any skin problems in where electrodes will be located unwillingness to use electrical stimulation 080 Single spontaneous delivery Other Placebo Intervention group: In this group, 30 to 45 minutes of electrical stimulation were obtained using a multistimulator (X735 Novin medical engineering company) at the start of the active phase (reaching the cervical dilatation of 4 cm in high electrodes and 30 to 45 minutes late in the active phase( cervical dilatation of 8 to 10 cm) will be applied at lower electrodes with a base frequency of 4000 Hz , a beat frequency of 80 to 120 Hz and pulse duration of 50 to 60 microseconds, in addition to routine care. Control group: They will be treated as a placebo group and the electrodes are similar to the intervention group and will be operated in the same phase with the intervention group, only the output of the device will be zero.  Both groups will receive routine care that includes checking vital signs of the mother and the fetus, the condition of the fetues, the status of the pouch, the need for oxytocin and medication. Pain severity. Timepoint: The pain will be evaluated in several stages in both groups; first, before interventions and care, immediately after intervention, then every hour until the second stage of delivery, and at the end one hour after the delivery. Method of measurement: It will be measured using the Visual Analog Scale (VAS). Duration of the active stage of labor. Timepoint: We will measure the time from the start of the active phase (reaching dilatation to 4 cm) to the end of the active phase (dilatation reaches 8 cm). Method of measurement: The duration will be determined from partography. Frequency of satisfactory labor progress. Timepoint: during the active phase of labor will be determined. Method of measurement: It will be determined by examining the amount of dilatation of the cervix by vaginal examination, the fetal head descending , and the characteristics of uterine contractions by using partography. The frequency of using sedative medications. Timepoint: From the start of interventions to an hour after the completion of labor. Method of measurement: The amount of its using dose will be recorded in the partography. Frequency of need for oxytocin injection. Timepoint: From the beginning of the interventions to the end of labor. Method of measurement: The use or non-use of oxytocin will be recorded in the form of a partograghy and, if used, the number of drops per minute will be recorded in the partography. 1st and 5th minute Apgar Score. Timepoint: The first and fifth minutes after birth will be checked. Method of measurement: The Apgar score is obtained using the Apgar score table. Tabriz University of Medical Sciences Approved 2019-07-01 Ethics committee of Tabriz University of Medical Sciences Daneshgah Ave., Rehabilitation Faculty, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)