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IRCT20230610058445N1 IRCT 2023-08-04 Khoram-Abad University of Medical Sciences The comparison of the effect of Entonox gas and Back massage on Labor pain in Pregnant Women The comparison of the effect of Entonox gas and Back massage on Labor pain in Pregnant Women 2023-06-22 anticipated 84 Complete https://irct.ir/trial/70667 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method will be accessible and based on the Inclusion criteria. In this way, after obtaining written consent from the samples, people are assigned to groups by block randomization. Entry of people into each of the groups is done according to the number of the selected blocks and the arrangement inside the block. At first, we divide the samples into two categories: primiparous and multiparous, Then, based on the sample size, we evaluate all possible modes of block formation. as regards that the sample size is 84 people and the number of groups is 3, we will have 42 primiparous mothers and 42 multiparous mothers. So we will have 14 blocks of 6, 7 blocks for primiparous and 7 blocks for multiparous. The randomization tool will be the Random Allocation Software. N/A Labor pain. Intervention 1: Control group: Since no pain reduction method is routinely performed for mothers in the intended maternity hospital, the control group will not receive any intervention, but they will receive psychological support, similar to the other two groups. If the mother requests to receive the pain reduction method, these people will be excluded from the study. Intervention 2: "Intervention group 1": In the back massage group, the massage technique will be massage with both hands from the T10 to S4 vertebra in a rhythmic, regular and ascending manner using the deep stroking method (deep pressure on the layers of the skin, muscles, fascia and tissue binder) and return to the first place by surface stroking method (soft pressure on the skin and its surrounding layers), in 3 times of 15 minutes and during three periods of dilation 4-5, 6-7 and 8-9 cm during contractions. Vaseline will be used to reduce the friction between the hand and the skin of the mother's back during the massage. The position of the mother while receiving the massage will be lying on the left side for all samples. Intervention 3: "Intervention group 2": In the Entonox group, gas inhalation by the mother in a self-controlled manner, during dilatation of 4 to 10 cm, starts as soon as the abdomen tightens (about 30 or 40 seconds before the onset of pain) and stops after the end of the pain (the mask is removed). The combination of nitrous oxide gas (N2O) or laughing gas with equal amounts of oxygen in a chamber is called Entonox. Entonox capsule should be placed in a vertical position and turned several times before use; Because nitrogen oxide is heavier than oxygen and the gases must be mixed well. The mask must be the size of the mother's face and must be firmly attached to the mother's face; also, proper ventilation should be established to prevent the remaining of the released gases in the environment. 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 no further information.
public Mozhgan Masoodi
Lorestan University of Medical Sciences, Shahid Anoushirvan Rezaei Sq, Moalem Ave
Khoram Abad Iran (Islamic Republic of) 6813833946 +98 66 3330 2033 Masoodi.m@lums.ac.ir Khoram-Abad University of Medical Sciences scientific Mozhgan Masoodi
Lorestan University of Medical Sciences, Shahid Anoushirvan Rezaei Sq, Moalem Ave
Khoram Abad Iran (Islamic Republic of) 6813833946 +98 66 3330 2033 Masoodi.m@lums.ac.ir Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Mother's desire to vaginal delivery A single fetus with a view of the apex of the head Gestational age Between 37 to 41 weeks The regularity of the fetal heartbeat with a number of 120-160 beats per minute The mother's vital signs are normal having minimum reading and writing literacy Dilatation 4-5 cm Having at least 2 to 3 spontaneous uterine contractions lasting 40-45 seconds within ten minutes Having less than 4 vaginal deliveries Body mass index 20-30 kg/m2 The fit of the fetal head with the mother's pelvis based on clinical examination The estimated weight of the fetus 2500-4000 grams Proportionality of uterine height with gestational age in clinical examination The normality of the number of fetal movements according to the mother's report or the reaction of the result of the non stress test Mother's age between 18-35 years 18 years 35 years Female The presence of medical and obstetrical problems in the current pregnancy Addiction to tobacco, drugs and alcohol drinks Height less than 145 cm The existence of any obstacles to vaginal delivery Existence of maternal or fetal risk factors The existence of contraindications for back massage (lumbar disc herniation, skin diseases, fever, etc.) The existence of contraindications to the use of Entonox (mother's inability to hold the mask, maxilla and facial fractures, impaired consciousness and intoxication, impaired oxygen supply, upper respiratory tract infection or respiratory disease, nasal deviation, chronic obstructive pulmonary disease, receiving large amounts of intravenous narcotics, vitamin B12 deficiency and mothers treated with vitamin B12, maxillofacial surgery in the last month, inner ear obstruction, fetal distress, unstable hemodynamic status, some heart diseases such as pulmonary hypertension, problematic airway, fullness of the mother's stomach and schizophrenia) Other Other Other Control group: Since no pain reduction method is routinely performed for mothers in the intended maternity hospital, the control group will not receive any intervention, but they will receive psychological support, similar to the other two groups. If the mother requests to receive the pain reduction method, these people will be excluded from the study. "Intervention group 1": In the back massage group, the massage technique will be massage with both hands from the T10 to S4 vertebra in a rhythmic, regular and ascending manner using the deep stroking method (deep pressure on the layers of the skin, muscles, fascia and tissue binder) and return to the first place by surface stroking method (soft pressure on the skin and its surrounding layers), in 3 times of 15 minutes and during three periods of dilation 4-5, 6-7 and 8-9 cm during contractions. Vaseline will be used to reduce the friction between the hand and the skin of the mother's back during the massage. The position of the mother while receiving the massage will be lying on the left side for all samples. "Intervention group 2": In the Entonox group, gas inhalation by the mother in a self-controlled manner, during dilatation of 4 to 10 cm, starts as soon as the abdomen tightens (about 30 or 40 seconds before the onset of pain) and stops after the end of the pain (the mask is removed). The combination of nitrous oxide gas (N2O) or laughing gas with equal amounts of oxygen in a chamber is called Entonox. Entonox capsule should be placed in a vertical position and turned several times before use; Because nitrogen oxide is heavier than oxygen and the gases must be mixed well. The mask must be the size of the mother's face and must be firmly attached to the mother's face; also, proper ventilation should be established to prevent the remaining of the released gases in the environment. Labor pain. Timepoint: Measurement of pain at the beginning of the study (before the intervention) and in the dilation of 4-5, 6-7 and 8-9 cm during the intervention. Method of measurement: Visual analog scale (VAS). The rate of changes in the mother's heart rate. Timepoint: Once before the intervention and then at 4-5, 6-7 and 8-9 cm dilation during the intervention. Method of measurement: Contec pulse oximetry model CMS5OD. The amount of changes in the mother's blood oxygen saturation percentage. Timepoint: Once before the intervention and then at 4-5, 6-7 and 8-9 cm dilation during the intervention. Method of measurement: Contec pulse oximetry model CMS5OD. Khoram-Abad University of Medical Sciences Approved 2023-05-24 Ethics Committee of Lorestan University of Medical Sciences Lorestan University of Medical Sciences, Shahid Anoushirvan Rezaei Sq, Moalem Ave Khoram abad Lorestan Iran (Islamic Republic of)