]>
IRCT20220221054085N1 IRCT 2022-10-27 Zanjan University of Medical Sciences Comparison of the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Acupuncture Points (Hegu and Sanyinhiao) on Duration, labor Pain Intensity and Need for Induction of the First Stage of Labor Comparison of the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Acupuncture Points (Hegu and Sanyinhiao) on Duration, labor Pain Intensity and Need for Induction of the First Stage of Labor: A Clinical Trial 2022-10-23 anticipated 124 Complete https://irct.ir/trial/62081 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Previous studies have focused on determining the effect of the TENS device on reducing labor pain, while in this study we have tried to consider its effect on labor duration and the need to induce labor, Randomization description: Samples are randomly entered into three groups of 42, so that in order to randomize the selection of samples by simple lottery method in one of the intervention groups 1 (Hugo point electrical stimulation), intervention 2 (San Ingiao electrical stimulation) or placebo group Placed. َAfter assessing the participants according to inclusion criteria and taking consent, we will exclude a ball from a bag. the red ball means first group, green ball means second group, and the white one means placebo group, Blinding description: In this study, one-way blinding will be performed and participants will be unaware that the device is turned on or not. 2-3 Pain intensity and duration of labour and the need for induction in the active phase of labor. Intervention 1: Intervention groups 1 (Hugo point electrical stimulation): In this study, the portable two-channel Max Tens 2000 device, which works with a battery, will be used with two pairs of electrodes. At the beginning of the intervention, when the person is in cervical dilatation of 3-4 cm, two electrodes will be placed in the Hugo area (located in the membrane between the thumb and index finger between the junction of the first and second metacarpal bones) in both hands and with continuous current, the frequency 100 Hz per minute and a wavelength of 250 microseconds will be set and alternately on for 20 minutes and off for 20 minutes, and this will continue until the end of the second stage of labor (dilation of 10 cm to the exit of the fetus). Intervention 2: Intervention 2 (San Injiao Electrical Stimulation): In this study, a portable two-channel Max Tens 2000 device that works with a battery and two pairs of electrodes will be used. At the beginning of the intervention, since the dilatation of the cervix is 3-4cm, two electrodes will be placed in the San Injiao area in both legs (at a distance of 4 fingers from the fingers of the same person above the inner ankle) and with continuous current, the frequency of 100 Hz It will be set to 250 microseconds per minute and the wavelength will be alternately on for 20 minutes and off for 20 minutes, and this will continue until the end of the second stage of labor (dilation of 10 cm to the exit of the fetus). Intervention 3: Control group: Placebo: In this study, the portable two-channel Max Tens device that works with a battery and two pairs of electrodes will be used. In this group, from the time of 3-4 cm dilatation of the cervix, two electrodes will be installed on the Hugo points on the hands and two electrodes on the San Injiao points on both feet, but no electric current will be established and the client will not know about the absence of current. Because we will turn on the device. And after the completion of the second stage of labor, the electrodes will be removed. Yes - There is a plan to make this available What will be shared: Personal information will not be identifiable after encryption. When: tarting 6 months after publication To whom: There are no restrictions on data presentation. Information can be provided after the publication of the article Conditions: Data are presented for comparison and systematic studies Where to obtain: To receive data, you can contact Sanaz Fayazi, az email address sanaz faiiazi@gmail.com 09128216204پ How to obtain: After the publication of the article, the data will be submitted within 10 days if the applicants receive an email or a call. Comments: No comment
public Sanaz Fayazi
mahdavi Blv.
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3314 8375 sanazfaiiazi@gmail.com Zanjan University of Medical Sciences scientific Zahra Najmi
Gavazang Blv. Mousavi Hospital
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3314 8371 zahranajmi@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Age is 18-35 years BMI below 30 Height above 150 Gestational age is 42-37 weeks. Be primiparous cephalic presentation No CPD based on examination by researcher and on-call Obstetrics Less than 6 hours have passed since the rupture of the membranes Education level is at least fifth elementary. Iranian no induction during labor no epilepsy. any use of painkillers since 3 hours before labor starts Must not be a user of cardiac pacemakers not to be addict no skin problem or scar in the region of electrodes contractions have started spontaneously single fetus no experience of using TENS before dilatation 3-5 cm 18 years 35 years Female no tendency to continue participating in the study using the oxytocin or prostaglandin be necessary using any drug during the labor childbirth by cesarean method allergy or burn in the region of TENS electrodes 075.8 075.8 Other specified complications of labour and delivery Treatment - Devices Treatment - Devices Treatment - Devices Intervention groups 1 (Hugo point electrical stimulation): In this study, the portable two-channel Max Tens 2000 device, which works with a battery, will be used with two pairs of electrodes. At the beginning of the intervention, when the person is in cervical dilatation of 3-4 cm, two electrodes will be placed in the Hugo area (located in the membrane between the thumb and index finger between the junction of the first and second metacarpal bones) in both hands and with continuous current, the frequency 100 Hz per minute and a wavelength of 250 microseconds will be set and alternately on for 20 minutes and off for 20 minutes, and this will continue until the end of the second stage of labor (dilation of 10 cm to the exit of the fetus). Intervention 2 (San Injiao Electrical Stimulation): In this study, a portable two-channel Max Tens 2000 device that works with a battery and two pairs of electrodes will be used. At the beginning of the intervention, since the dilatation of the cervix is 3-4cm, two electrodes will be placed in the San Injiao area in both legs (at a distance of 4 fingers from the fingers of the same person above the inner ankle) and with continuous current, the frequency of 100 Hz It will be set to 250 microseconds per minute and the wavelength will be alternately on for 20 minutes and off for 20 minutes, and this will continue until the end of the second stage of labor (dilation of 10 cm to the exit of the fetus). Control group: Placebo: In this study, the portable two-channel Max Tens device that works with a battery and two pairs of electrodes will be used. In this group, from the time of 3-4 cm dilatation of the cervix, two electrodes will be installed on the Hugo points on the hands and two electrodes on the San Injiao points on both feet, but no electric current will be established and the client will not know about the absence of current. Because we will turn on the device. And after the completion of the second stage of labor, the electrodes will be removed. Duration of the first stage of labor: Accurate recording of the start time of the active phase from dilatation of 4 cm to complete dilatation of the cervix (will be measured on a minute scale). Timepoint: from dilatation of 4 cm to complete dilatation of the cervix. Method of measurement: TV. Pain ruler is a visual tool for determining the severity of pain through self-reporting. Scores range from 0 to 10. A score of 3-0 indicates mild pain, 4-7 indicates moderate pain, and 8-10 indicates severe pain. Timepoint: from dilatation of 4 cm to complete dilatation of the cervix. Method of measurement: macGil ruler. According to the diagnosis of the treating physician and recording the order to start induction of labor in the patient's file. Timepoint: from dilatation of 4 cm to complete dilatation of the cervix. Method of measurement: Trans vaginal examination. Zanjan University of Medical Sciences Approved 2019-06-15 Ethical committee of Zanjan university of medical sciences No12, Khaje nasir Street, Maraghe East Azarbaijan Iran (Islamic Republic of)