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IRCT20170515033989N3 IRCT 2023-04-02 Shahid Beheshti University of Medical Sciences The effect of Transcutaneous Electrical Nerve Stimulation (TENS) on post Cesarean Section pain severity The effect of Transcutaneous Electrical Nerve Stimulation (TENS) on post Cesarean Section pain severity in comparison with the control group 2023-04-21 anticipated 60 Complete https://irct.ir/trial/69247 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization method is used for randomization. In this way, ten blocks of six are used. In each block, there are three people in the control group and three people in the case group. In order for the random allocation process to be done correctly, a person who is not participating in the study forms the blocks using the website https://www.Randomization.com, in other words, the central randomization method is used. Every time the researcher found a patient who met the conditions to enter the study. He contacts the person responsible for random allocation and asks whether the patient is in the control group or the control group, and this continues until the samples are completed, Blinding description: In this study, TENS device is connected to both case and control groups, however, it is active in the case group and inactive in the control group. The person who fills in the questionnaire and records the outcomes, the person who performs the analysis, are blind to the membership of participants. N/A cesarean section. Intervention 1: Intervention group: Use of coupled TENS and pethidine and diclofenac suppositories to reduce pain in cesarean section patients. The method of administering pethidine 50 mg intramuscularly after the patient enters the ward and the method of administering diclofenac 1 tablet at least every 8 hours on the first and second day if the patient needs it. In this group, four TENS pads (HM-1000, made in South Korea) are placed, two in the lower abdomen and two in the waist area. TENS is set with a frequency of 80 Hz, with an intensity of 0 to 80 (according to the patient's wish) and the frequency will be 100 Hz. TENS will remain connected for up to 24 hours. Intervention 2: Control group: Control group: Use of unbound TENS (placebo) and pethidine and diclofenac suppository to reduce pain in People who have undergone cesarean section. The method of administering pethidine is 50 mg intramuscularly after the patient enters the ward and the method of administering diclofenac is 1 tablet at least every 8 hours on the first and second day if the patient needs it. In this group, four TENS pads (HM-1000, made in South Korea) are placed two in the lower abdomen and two in the waist area, but the connection wire between the pad and the device is not conected. TENS will remain connected for up to 24 hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is Maintain participant informations
public Minoo Yaghmaei
Taleghani Hospital, Arabi st., Daneshjoo Blv, Shahriari sq., Evin, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2560 YAGHMAEIM@YAHOO.COM Shahid Beheshti University of Medical Sciences scientific Minoo Yaghmaei
Taleghani Hospital, Arabi st., Daneshjoo Blv, Shahriari sq., Evin, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2560 YAGHMAEIM@YAHOO.COM Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) pregnancy with a live fetus Single pregnancy cephalic presentation more than 37 weeks of gestational age Body mass index below 30 kg / m2 Candidate for termination of pregnancy with cesarean section no limit no limit Female cesarean section due to cord prolapse and cesarean section in full dilation Mother's inability to speak Persian drug abuse history of chronic pain history of Continuous use of painkillers history of using tense other procedures like myomectomy or tubal ligation during cesarean section 082.9 Delivery by caesarean section, unspecified Treatment - Devices Placebo Intervention group: Use of coupled TENS and pethidine and diclofenac suppositories to reduce pain in cesarean section patients. The method of administering pethidine 50 mg intramuscularly after the patient enters the ward and the method of administering diclofenac 1 tablet at least every 8 hours on the first and second day if the patient needs it. In this group, four TENS pads (HM-1000, made in South Korea) are placed, two in the lower abdomen and two in the waist area. TENS is set with a frequency of 80 Hz, with an intensity of 0 to 80 (according to the patient's wish) and the frequency will be 100 Hz. TENS will remain connected for up to 24 hours. Control group: Control group: Use of unbound TENS (placebo) and pethidine and diclofenac suppository to reduce pain in People who have undergone cesarean section. The method of administering pethidine is 50 mg intramuscularly after the patient enters the ward and the method of administering diclofenac is 1 tablet at least every 8 hours on the first and second day if the patient needs it. In this group, four TENS pads (HM-1000, made in South Korea) are placed two in the lower abdomen and two in the waist area, but the connection wire between the pad and the device is not conected. TENS will remain connected for up to 24 hours. The dose of painkillers (diclofenac suppositories and pethidine injections). Timepoint: in first 6 hours, second 6 hours, second 12 hours, second day after cesarean section. Method of measurement: Dosage consumed (mg)- First, it is checked from the medical record and then it is confirmed by asking the patient. Pain. Timepoint: 2, 4, 6, 12, 24, 48 hours after cesarean section. Method of measurement: Numeral Visual scale (NVS). Patient satisfaction with the analgesia process. Timepoint: 6,12, 24, 48 hours after cesarean section. Method of measurement: Based on the question from the patient - bad - normal - good - excellent. Side effects. Timepoint: At the time of patient discharge. Method of measurement: Question from the patient and examination and mention of the complication. Shahid Beheshti University of Medical Sciences Approved 2023-03-07 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Arabi st., Daneshjoo Blv, Shahriari sq., Evin, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)