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IRCT20170515033989N2 IRCT 2021-11-17 Shahid Beheshti University of Medical Sciences The effect of TENS on the severity of pain during medical abortion pain in the first trimester of pregnancy The effect of TENS on the severity of pain during medical abortion in the first trimester of pregnancy in comparison with the control group 2021-11-01 anticipated 60 Complete https://irct.ir/trial/59208 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization of block: There will be twelve blocks, each block containing 5 units. For randomization statistical software will be used and the result will provided to a person outside the research group. For each patient who meets the including, this person will be contacted and she will announce the group (control or case), 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, as well as the researcher who collects the information and the person who performs the analysis, are blind to the membership of participants. 2-3 Medical Abortion. Intervention 1: Intervention group: Using TENS and Ibuprofen to reduce pain in first trimester abortion candidates with misoprostol - Ibuprofen administration method: Ibuprofen Tab ( produced by Loghman Pharmaceuticals) 200 mg (in case of moderate pain) or 400 mg (in case of severe pain). TENS (HMB-1000 TENS, South Korea) : Four pads are placed two in the lower abdomen and two in the waist area, which is connected to the device with a wire. TENS is set at a frequency of 80 Hz with an intensity of 0 to 80 (according to the patient's wishes). Intervention 2: Control group: Use of unbound TENS (placebo) and ibuprofen to reduce pain in first trimester abortion candidates with misoprostol - Method of administration of ibuprofen tablet (produced by Loghman Pharmaceuticals) 200 mg (in case of moderate pain) or 400 mg (in case of Severe pain). 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 connected. Yes - There is a plan to make this available What will be shared: All data is available on demand after being unidentifiable When: Up to six months from the publication of the results To whom: Researchers working in academic and scientific institutions Conditions: Mention a valid request from the applicant Where to obtain: Dr. Minoo Yaghmaei m.yaghmaei@sbmu.ac.ir How to obtain: Must be emailed. Comments:
public Minoo Yaghmaei
Taleghani Hospital, Erabi street, Daneshjoo Blv, Shahriari sq, Evin
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2560 m.yaghmaei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Minoo Yaghmaei
Taleghani Hospital, Erabi street, Daneshjoo Blv, Shahriari sq, Evin
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2560 m.yaghmaei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Single pregnancy Less than 13 weeks of pregnancy Body mass index below 30 kg / m2 Candidate for termination of pregnancy with Misoprostol no limit no limit Female Sensitivity to Misoprostol and Ibuprofen Drug addiction History of chronic pain History of using TENS Treatment - Devices Treatment - Devices Intervention group: Using TENS and Ibuprofen to reduce pain in first trimester abortion candidates with misoprostol - Ibuprofen administration method: Ibuprofen Tab ( produced by Loghman Pharmaceuticals) 200 mg (in case of moderate pain) or 400 mg (in case of severe pain). TENS (HMB-1000 TENS, South Korea) : Four pads are placed two in the lower abdomen and two in the waist area, which is connected to the device with a wire. TENS is set at a frequency of 80 Hz with an intensity of 0 to 80 (according to the patient's wishes). Control group: Use of unbound TENS (placebo) and ibuprofen to reduce pain in first trimester abortion candidates with misoprostol - Method of administration of ibuprofen tablet (produced by Loghman Pharmaceuticals) 200 mg (in case of moderate pain) or 400 mg (in case of Severe pain). 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 connected. Ibuprofen intake. Timepoint: Once at the end of the abortion process. Method of measurement: Dosage consumed throughout the abortion process (mg). Pain. Timepoint: At the beginning of hospitalization - at the beginning of using TENS - at 2, 4, 6, 8 and 10 hours after TENS. Method of measurement: Numeral Visual scale (NVS). Satisfaction with the whole abortion process. Timepoint: Once the abortion process is completed. Method of measurement: Based on the question from the patient - bad - normal - good - excellent. Satisfaction with the analgesia process. Timepoint: Once the abortion process is completed. Method of measurement: Based on the question from the patient - bad - normal - good - excellent. Satisfaction with the use of the TENS device. Timepoint: Once the abortion process is completed. Method of measurement: Based on the question from the patient - bad - normal - good - excellent. Duration of use of TENS. Timepoint: Once the abortion process is completed. Method of measurement: Minute. Side effects. Timepoint: Once the abortion process is completed. Method of measurement: Question from the patient and examination and mention of the complication. Shahid Beheshti University of Medical Sciences Approved 2021-09-18 Ethics committee of Shahid Beheshti University of Medical Sciences Taleghani Hospital, Arabi st., Daneshjoo Blv, Shahriari sq., Evin Tehran Tehran Iran (Islamic Republic of)