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IRCT20170506033834N10 IRCT 2022-07-05 Tabriz University of Medical Sciences The effect of pharmacological and non-pharmacological analgesia during childbirth Determining the effect of pharmacological and non-pharmacological analgesia on Childbirth fear, experience and postpartum depression: a randomized controlled clinical trial 2022-08-06 anticipated 33 Complete https://irct.ir/trial/64547 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will then be randomly assigned to two groups receiving remifentanil analgesic and non-pharmacological analgesia using RAS(Random Allocation Software) based on the number of deliveries (1 or 2) with 4 and 6 blocks with a ratio of 1: 1. In order to hide the allocation (Allocation Concealement), opaque envelopes are numbered in a row, which will be used as a type of intervention written on paper. Envelopes will also be prepared and randomly assigned by the non-involved person. N/A Postpartum depression. Intervention 1: Intervention group: In the group of painless drug delivery in dilation of 4-6 cm, remifentanil will be performed by an anesthesiologist according to the national protocol of painless delivery using a continuous intravenous infusion pump at a dose of 0.05 μg / kg / min. After dilation is complete, ie in the second stage of labor, the infusion will be stopped. Intervention 2: Control group: For the non-pharmacological analgesia group in the active phase of labor, lumbar massage, lukewarm abdominal shower, pressure on the sacrum, breathing techniques and upright positions are used. No - There is not a plan to make this available Justification or reason for not sharing IPD is خیر
public Esmat Mehrabi
Faculty of Nursing and Midwifery `South shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 b.mehrabi@yahoo.com Tabriz University of Medical Sciences scientific Esmat Mehrabi
South Shariati Street, Faculty of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 b.mehrabi62@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) En Women with first and second pregnancies Age 45-18 years Living in the city of Tabriz Tendency to deliver with remifentanil analgesia and non-drug analgesia Gestational age 42-37 weeks 18 years 45 years Female Multiple pregnancies Chronic or induced or aggravated diseases in pregnancy such as hypertension, cardiovascular disease, diabetes, preeclampsia, etc. Indications for cesarean section such as placenta previa, non-cephalic presentations, abnormal fetal heartbeats, etc. . Having a history of depression based on self-expression or taking anti-anxiety and anti-depressant medications Occurrence of a significant stressful incident in the family during the last 6 months, such as the death of a loved one, separation from a spouse and ... History of cesarean section or uterine incision Abnormal pregnancy trends such as polyhydramnios, oligohydramnios, intrauterine growth disorder Body mass index 35 and above Hospitalization in dilatation after 6 cm Unplanned pregnancy incision Tendency to use other methods of analgesia History of attending physiological delivery classes O90.6 Postpartum mood disturbance Treatment - Drugs Treatment - Other Intervention group: In the group of painless drug delivery in dilation of 4-6 cm, remifentanil will be performed by an anesthesiologist according to the national protocol of painless delivery using a continuous intravenous infusion pump at a dose of 0.05 μg / kg / min. After dilation is complete, ie in the second stage of labor, the infusion will be stopped Control group: For the non-pharmacological analgesia group in the active phase of labor, lumbar massage, lukewarm abdominal shower, pressure on the sacrum, breathing techniques and upright positions are used. Score of Fear of chilbirth from Wijma and Delivery Fear Scale(DFS) questionnaires. Timepoint: Fear during labor will measured at 8 cm dilatation and one month after delivery. Method of measurement: Fear of childbirth in labor using the Delivery Fear Scale (DFS) Measures fear of childbirth. During labor, the researcher reads the ten statements of the scale aloud. The woman responds orally to each phrase with a number between 1 and 10 (1 = "I do not agree at all", 10 = "Strongly agree"; total score 10 to 100). The higher the score, the greater the fear. After starting the intervention, 8 cm dilatation will be completed by the participants through interviews. Cronbach's alpha coefficient for DFS structures in Iran (0.77) has been calculated, which indicates the desired internal compatibility. In other studies, this scale had a Cronbach's alpha coefficient of 0.91, which is similar to the results of Wijma et al. (33). ) Will be measured. The WDE-Q (B) questionnaire was designed by Wijma et al. To measure the severity of fear of childbirth in the postpartum stage. Mothers rate their feelings and personal cognition on a 6-point Likert scale from 0 to 5. In general, the score obtained is the sum of the scores of all items. The range of scores is between zero and 165. A score less than or equal to 37 indicates low fear, a score of 38 to 65 indicates moderate fear, a score equal to or greater than 66 indicates high fear, and a score above 85 indicates severe fear. (34) The higher the fear of childbirth, the higher the score. This questionnaire will be completed at the time of hospitalization. The validity and reliability of this questionnaire in Iran has been confirmed by Mortazavi et al. Cronbach's alpha coefficient is set at 0.914 (51). Score of Child birth experience in childbirth experience questionnaire (SEQ-2.0). Timepoint: Childbirth experience will be measured one month after delivery. Method of measurement: Thechilbirth experience will be measured using the Childbirth Experiences Questionnaire version 2.0 (CEQ-2.0). This questionnaire, which was designed by Dencker et al., contained 23 questions in a 4-point Likert scale. In this tool, the questions answered on a visual scale are converted into values ​​from 1 to 4: scores 0-40 (score 1), scores 41-60 (score 2), 61-80 (score 3), 81-100 (score 3). score 4). Sentences with negative connotations (experiencing severe pain, feeling tired, fear and having a bad memory) are scored negatively. High average scores in this tool mean a more positive experience of childbirth . This questionnaire will be completed by the participants one month after giving birth. The validity and reliability of this questionnaire in Iran has been confirmed by Ghanbari Homai et al. The reliability of the questionnaire was determined by Cronbach's alpha method of 0.93 and the intraclass correlation coefficient was determined as 0.97. Score of postpartum deppresion from the Edinburgh Depression Questionnaire. Timepoint: Postpartum depression will be measured one month after delivery. Method of measurement: Postpartum depression is measured using the Edinburgh Depression Questionnaire. This tool has 10 four-choice questions, each question has a score of 0 to 3 and the total score ranges from 0 to 30. The mother chooses the answers that she felt during the last week that the minimum score in this tool is zero and the maximum score is 30, and a score of 12 and above is considered depression. Validity and reliability of this questionnaire in Montazeri's study has been confirmed in Iran. The reliability of the questionnaire was determined by Cronbach's alpha method of 0.77 and by test method at 0.8. Score of childbirth pain. Timepoint: Score of childbirth pain during labor. Method of measurement: To measure the intensity of pain, the VAS: Visual Analogue scale is used, which is the same as the pain ruler. The duration of the first, second and third stage of labor. Timepoint: The duration of the first, second and third stage of labor during labor. Method of measurement: The duration of the first, second and third stage of labor during labor with in hours or minutes. Apgar score of baby. Timepoint: Apgar score in first and fifth minute. Method of measurement: Apgar score in first and fifth minute with apgar scale. Frequency of Postpartum hemorrhage. Timepoint: Postpartum hemorrhage in the first 24 hours. Method of measurement: Postpartum hemorrhage based on document. Frequency ofcesarian. Timepoint: Delivery Type after chilbirth. Method of measurement: Frequency ofcesarian based on document. Tabriz University of Medical Sciences Approved 2022-06-01 Ethics Committee of Tabriz University of Medical Sciences Third Floor of Research and Technology Vice-Chancellor, Central Building No. 2/ Tabriz University of Medical Sciences/ Golgasht Street /Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)