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IRCT20180624040219N1 IRCT 2018-09-19 Iranshahr University of Medical Sciences The effect of curative and thermotherapy on the severity of labor pain Compare effects of cold and heat therapy on labor pain intensity and duration of labor in nulliparous women who referred to Iran haspital 2018-09-23 anticipated 105 Complete https://irct.ir/trial/32217 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A The effect of Thermal Therapy and Cold Therapy on the severity of labor pain and delivery time. Intervention 1: First intervention group: In the heat therapy group, the level of heat in the bag is controlled by the forearm of the researcher's hands,the heat bag cover by tine cloth the first stage is placed in the lower back and in the second stage in the supraPubic and Its duration depends on the desire of woman. The acceptable duration for a first-time heat therapy is at least 60 minutes and in the second stage, at least 5 minutes. The temperature of the hot water bottle is adjusted between 38-40. The severity of pain will be measured in the dilatation 3-4, 7-8, 10-9 and the second stage of delivery with the Visual Analogue Scale (VAS). The duration of the first, second and third stages of labor, the first and fifth minute APGAR, mean heart rate, type of delivery, perineum status and maternal satisfaction will be assessed. Intervention 2: Intervention group: Second intervention group: Cold Therapy. Before of any intervention, the severity of the pain in the 4 cm dilatation is measured by showing a graded ruler. the Ice Bag cover by thin cloth and put on back in the first stage and it put in second stage in the perineal and suprapubic . The acceptable duration for cold therapy is at least 60 minutes in the first stage and at least 5 minutes in the second stage. The temperature of the ice bag is between 0 to -5 degrees.The severity of pain will be measured in the dilatation 3-4, 7-8, 10-9 and the second stage of delivery with the Visual Analogue Scale (VAS). The duration of the first, second and third stages of labor, the first and fifth minute APGAR, type of delivery, perineum status and maternal satisfaction will be assessed. Intervention 3: Control group: For the control group, the usual care is done.The severity of pain will be measured in the dilatation 3-4, 7-8, 10-9 and the second stage of delivery with the Visual Analogue Scale (VAS). The duration of the first, second and third stages of labor, the first and fifth minute APGAR, type of delivery, perineum status and maternal satisfaction will be assessed. 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 No more information
public Mahnaz Didehvar
Balooch Blvd
Iranshahr Iran (Islamic Republic of) 9914786138 +98 54 3721 0481 didevar.m@gmail.com Iranshahr University of Medical Sciences scientific Mahnaz Didehvar
Balooch Boulvar
Iranshahr Iran (Islamic Republic of) 9914786138 +98 54 3721 0481 didevar.m@gmail.com Iranshahr University of Medical Sciences Iran (Islamic Republic of) 1- Age 18 to 35 years 2. At the beginning of the active phase of labor (dilatation 3 to 4CM) 3- Gestational age 37- 41 weeks 4- Single-crowned pregnancy 5- Cephalic sedation 18 years 35 years Female 1- Diagnosis of mental and anatomical disorders (psychosis, schizophrenia, uterine anomalies, pelvic stenosis 2. Chronic known disease (heart disease, pulmonary, hypertension, diabetes Skin diseases (any lesion, inflammation and eczema in the area of thermal therapy and cold therapy Gestational hypertension Cephalopods10. Poly and Oligo-Hydramonus with ultrasound Reduce fetal movements12- IUGR13. Fetal death1 Rupture of curtains for more than 12 hours. Discontinuity of the head of the fetus with the pelvis Abnormal heartbeat patterns History of chronic pelvic pain Infertility record Any complications experienced during the study (abnormal placenta, abnormal position of the embryo, umbilical cord prolapse) unwillingness to continue the intervention Use of any medication or analgesia Treatment - Devices Treatment - Devices Treatment - Devices First intervention group: In the heat therapy group, the level of heat in the bag is controlled by the forearm of the researcher's hands,the heat bag cover by tine cloth the first stage is placed in the lower back and in the second stage in the supraPubic and Its duration depends on the desire of woman. The acceptable duration for a first-time heat therapy is at least 60 minutes and in the second stage, at least 5 minutes. The temperature of the hot water bottle is adjusted between 38-40. The severity of pain will be measured in the dilatation 3-4, 7-8, 10-9 and the second stage of delivery with the Visual Analogue Scale (VAS). The duration of the first, second and third stages of labor, the first and fifth minute APGAR, mean heart rate, type of delivery, perineum status and maternal satisfaction will be assessed. Intervention group: Second intervention group: Cold Therapy. Before of any intervention, the severity of the pain in the 4 cm dilatation is measured by showing a graded ruler. the Ice Bag cover by thin cloth and put on back in the first stage and it put in second stage in the perineal and suprapubic . The acceptable duration for cold therapy is at least 60 minutes in the first stage and at least 5 minutes in the second stage. The temperature of the ice bag is between 0 to -5 degrees.The severity of pain will be measured in the dilatation 3-4, 7-8, 10-9 and the second stage of delivery with the Visual Analogue Scale (VAS). The duration of the first, second and third stages of labor, the first and fifth minute APGAR, type of delivery, perineum status and maternal satisfaction will be assessed. Control group: For the control group, the usual care is done.The severity of pain will be measured in the dilatation 3-4, 7-8, 10-9 and the second stage of delivery with the Visual Analogue Scale (VAS). The duration of the first, second and third stages of labor, the first and fifth minute APGAR, type of delivery, perineum status and maternal satisfaction will be assessed. Initial Outcome Assessment of labor pain according to vas. Timepoint: Before intervention, dilatation of 3 cm, dilatation 5-6 cm, dilatation of 10-9 cm, and second stage of labor. Method of measurement: Visual Analogue scale. Iranshahr University of Medical Sciences Approved 2017-06-19 Ethics committee of Iranshahr University of Medical Sciences Balooch Blvd Iranshahr Sistan-va-Balouchestan Iran (Islamic Republic of)