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IRCT20180707040370N4 IRCT 2019-03-26 Zanjan University of Medical Sciences The effect of Trans-cutaneous electrical nerve stimulation (TENS) and Entonox gas on labor pain control The comparison of the effect of Tens and Entonox gas on pain control in Primigravida 2017-10-12 anticipated 120 Complete https://irct.ir/trial/37572 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were randomly assigned to the three groups of 40 recipients of TENS and Entonox gas and other group without any intervention using the Select (randbetween (1; 2)) command, in the Excel computer program. 3 The comparison of TENS and Entonox on delivery pain. Intervention 1: Intervention group 1: the effect of TENS on labor pain. In the TENS group, first place the electrodes at the appropriate place behind the patient. The electrodes are parallel to the spine. The first pair of electrodes is placed between the tenth thoracic and the first lumbar vertebra. The second pair of electrodes is placed between the second to fourth sacral vertebrae. Then, mother can change the frequency of the device from low (at least pain relief) to high (maximum pain relief). Intervention 2: Intervention group 2: the effect of Entonox gas on delivery pain. In the Entonox group, we first teach to the patient how to use Enonox gas. Gas usage should begin at the beginning of uterine contraction. The capsule should be shaken before use. Gas inhalation will be continued with a deep inhalation, a pause at the end and a rest phase. By the of uterine contraction, the gas inhalation will be stopped and the patient will use the room air. We will stopp using Entonox when the patient won't cooperate or the level of the patient's consciousness will be decreased. Intervention 3: Control group: without any intervention. Yes - There is a plan to make this available What will be shared: A portion of the information, such as information on the main outcome or the like, can be shared. When: Start the access period 6 months after printing the results To whom: Researchers working in academia Conditions: Any analysis on the data is allowable with the source citation. Where to obtain: Zanjan University of Medical Sciences How to obtain: 6 months after printing results Comments:
public Behnaz Molaei
Zanjan University of Medical Sciences, Azadi Blvd
Zanjan Iran (Islamic Republic of) 4515613191 +98 24 3342 0677 molaei@zums.ac.ir Zanjan University of Medical Sciences scientific Behnaz Molaei
Zanjan University of Medical Sciences, Azadi Blvd
Zanjan Iran (Islamic Republic of) 4515613191 +98 24 3342 0677 molaei@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Nulliparity Being at the age of 15-45 years old Gestatinal age more than 37 weeks Singleton pregnancy Beginning of the active phase of delivery 15 years 45 years Female Need to emergency cesarean section O63 Long labor Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: the effect of TENS on labor pain. In the TENS group, first place the electrodes at the appropriate place behind the patient. The electrodes are parallel to the spine. The first pair of electrodes is placed between the tenth thoracic and the first lumbar vertebra. The second pair of electrodes is placed between the second to fourth sacral vertebrae. Then, mother can change the frequency of the device from low (at least pain relief) to high (maximum pain relief). Intervention group 2: the effect of Entonox gas on delivery pain. In the Entonox group, we first teach to the patient how to use Enonox gas. Gas usage should begin at the beginning of uterine contraction. The capsule should be shaken before use. Gas inhalation will be continued with a deep inhalation, a pause at the end and a rest phase. By the of uterine contraction, the gas inhalation will be stopped and the patient will use the room air. We will stopp using Entonox when the patient won't cooperate or the level of the patient's consciousness will be decreased. Control group: without any intervention Pain score. Timepoint: At the beginning of the study and at dilatations of 4-6, 6-8, 8-10 cm. Method of measurement: Visual Analogue Scale. Zanjan University of Medical Sciences Approved 2016-08-09 Ethics committee of Zanjan University of Medical Sciences Zanjan University of Medical Scienes, Azadi Blvd Zanjan Hamadan Iran (Islamic Republic of)