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IRCT20080826001096N6 IRCT 2018-05-02 Research vice-chancellorship, Guilan University of Medical Sciences Effect of TENS on the reduction of labor pain Evaluation and comparison Effect of Transcutaneouse Electrical Nerve Stimulation (TENS) in Lumbar & acupuncture points in reducing Labor Pain 2018-01-05 anticipated 84 Complete https://irct.ir/trial/28433 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Mothers are randomly assigned to four groups of A, B, C, D with a randomized balance block method of 1: 1: 1: 1 ratio. Random sequences will be generated using the Random Generator program and will be assigned to the serial number in closed envelopes in the acceptance section, and will be given to eligible individuals who are enrolled in the study, respectively, Blinding description: Labor practitioners (the first operator) who have been trained to interview and complete the form and application of TENS on the suitable points, will be conducted on the mothers bedside. The relevant code is recorded in the patient's information collection form. The operator completes the demographic characteristics and delivery process of each patient in the coded form according to the medical records. The patient and the outcome evaluator of pain (second operator) do not know the nature of the codes (double blind study). N/A Delivery. Intervention 1: Placebo control (Inactive lumbar and acupuncture TENS group): Lumbar and acupuncture points electrodes will be connected to the study participants and will receive very little stimulation (at 5 mA) without changing the frequency in a few seconds, so that the mother reports a tingling sensation. This flow is not repeated until the end of the first stage of labor. The pain score according to the schedule is measured in four stages. Intervention 2: Intervention group: B) Active acupuncture TENS group: Lumbar and acupuncture points electrode-pads will be connected to the study participants. The acupuncture points TENS machine is in the hands of the trained operator. Based on body weight of the participants, the output current is stabilized at 10 to 18 mA. For a person of higher weight, you need to provide more effective electrical stimulation, which elicits a tingling sensation. For each mother, for half an hour, pulse are sent to acupuncture points. Repeated applications of TENS will be sent upon mother's request (up to 4 phase ).The lumbar TENS machine is placed in the hands of the mother. Lumbar electrode-pads will receive very little stimulation (at 5 mA) without changing the frequency in a few seconds, so that the mother reports a tingling sensation. This flow is not repeated until the end of the first stage of labor. The pain score according to the schedule will be measured in four stages. Intervention 3: Intervention group: Active Lumbar TENS group: Lumbar and acupuncture points electrode-pads will be connected to the study participants. The Lumbar TENS machine is in the hands of the mother. The mother is taught how to increase the degree of electrical pulse with the onset of pain, which is the most pain-relieving effect, with the slightest sensation of tingling (Burst waves). Each time the contractions of labor, Boost waves sent by the mother. In this way, the pulse of the lumbar electrodes is sent to the mother's self-diagnosis to reduce pain at the onset of contractions. Then, the mother takes an active role. The acupuncture points TENS machine is in the hands of the trained operator. The acupuncture points electrodes sends very little stimulation (at 5 mA) without changing the frequency in a few seconds, so that the mother reports an tingling transient sensation. This electrical current is not repeated until the end of the first stage of labor. The pain score according to the schedule will be measured in four stages. Intervention 4: Intervention group: Active lumbar and acupuncture TENS group: Lumbar and acupuncture points electrode-pads will be connected to the study participants. The Lumbar TENS machine is in the hands of the mother. The mother is taught how to increase the degree of electrical pulse with the onset of pain, which is the most pain-relieving effect, with the slightest sensation of tingling (Burst waves). Each time the contractions of labor, Boost waves sent by the mother.The acupuncture points TENS machine is in the hands of the trained operator. For each mother, for half an hour, pulse are sent to acupuncture points. Repeated applications of TENS will be sent upon mother's request (up to 4 phase ). The pain score according to the schedule will be measured in four stages. 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 There is still planning to share and publish.
public Fatemeh Farjad Bastani
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839- 41446 +1 333369224 dr.farjadbastani@gmail.com Guilan University of Medical Sciences scientific Dr. Seyedeh Hajar sharami
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839 -41446 +98 13 3336 9224 sharami@gums.ac.ir Guilan University of Medical Sciences Iran (Islamic Republic of) Pregnant women aged 35-18 years old Having reading and writing skills The gestational age: 41-37 weeks Single pregnancy Cephalic fetal presentation Latent phase of labor (dilatation less than 4-3 cm) 18 years 35 years Female Use of epidural analgesia or other anesthetics within 24 hours before entering the study The experience of using TENS or Acupuncture The use of oxytocin to induce and augmentation of labor before entering the study Mental and anatomical disorders (psychosis, schizophrenia, uterine abnormalities and pelvic stenosis) chronic diseases (heart disease, hypertension, diabetes) Skin diseases e (any lesion, inflammation and eczema) in the area of intervention high risk pregnancies (gestational hypertension, polyhydramnios and oligohydramnios known by ultrasound) Reduce fetal movements before entering the study Intrauterine growth retardation (IUGR) Rupture of membrane for more than 12 hours Use narcotics 12 hours before entering the study Infertility history O83.9 Assisted single delivery, unspecified Placebo Treatment - Devices Treatment - Devices Treatment - Devices Placebo control (Inactive lumbar and acupuncture TENS group): Lumbar and acupuncture points electrodes will be connected to the study participants and will receive very little stimulation (at 5 mA) without changing the frequency in a few seconds, so that the mother reports a tingling sensation. This flow is not repeated until the end of the first stage of labor. The pain score according to the schedule is measured in four stages. Intervention group: B) Active acupuncture TENS group: Lumbar and acupuncture points electrode-pads will be connected to the study participants. The acupuncture points TENS machine is in the hands of the trained operator. Based on body weight of the participants, the output current is stabilized at 10 to 18 mA. For a person of higher weight, you need to provide more effective electrical stimulation, which elicits a tingling sensation. For each mother, for half an hour, pulse are sent to acupuncture points. Repeated applications of TENS will be sent upon mother's request (up to 4 phase ).The lumbar TENS machine is placed in the hands of the mother. Lumbar electrode-pads will receive very little stimulation (at 5 mA) without changing the frequency in a few seconds, so that the mother reports a tingling sensation. This flow is not repeated until the end of the first stage of labor. The pain score according to the schedule will be measured in four stages. Intervention group: Active Lumbar TENS group: Lumbar and acupuncture points electrode-pads will be connected to the study participants. The Lumbar TENS machine is in the hands of the mother. The mother is taught how to increase the degree of electrical pulse with the onset of pain, which is the most pain-relieving effect, with the slightest sensation of tingling (Burst waves). Each time the contractions of labor, Boost waves sent by the mother. In this way, the pulse of the lumbar electrodes is sent to the mother's self-diagnosis to reduce pain at the onset of contractions. Then, the mother takes an active role. The acupuncture points TENS machine is in the hands of the trained operator. The acupuncture points electrodes sends very little stimulation (at 5 mA) without changing the frequency in a few seconds, so that the mother reports an tingling transient sensation. This electrical current is not repeated until the end of the first stage of labor. The pain score according to the schedule will be measured in four stages. Intervention group: Active lumbar and acupuncture TENS group: Lumbar and acupuncture points electrode-pads will be connected to the study participants. The Lumbar TENS machine is in the hands of the mother. The mother is taught how to increase the degree of electrical pulse with the onset of pain, which is the most pain-relieving effect, with the slightest sensation of tingling (Burst waves). Each time the contractions of labor, Boost waves sent by the mother.The acupuncture points TENS machine is in the hands of the trained operator. For each mother, for half an hour, pulse are sent to acupuncture points. Repeated applications of TENS will be sent upon mother's request (up to 4 phase ). The pain score according to the schedule will be measured in four stages. Pain severity score. Timepoint: 1. The beginning of the study, 2.One hour after the close of TENS 3.The beginning of the active phase (dilation of 4-5 cm) 4.The end of the first phase (full dilatation). Method of measurement: visual analogue scale (VAS). TENS satisfaction score. Timepoint: 4 hours after childbirth. Method of measurement: Researcher made 3 questions questionnaire. Research vice-chancellorship, Guilan University of Medical Sciences Approved 2017-11-04 • Ethics committee of Guilan University of Medical Sciences Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave., Rasht, Guilan, IRAN Rasht Guilan Iran (Islamic Republic of)