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IRCT20200604047655N1 IRCT 2020-09-29 Birjand University of Medical Sciences Evaluation of the effectiveness of Dialectical Behavioral Therapy and Aromatherapy of Lavender on pregnancy and Childbirth Outcomes The Effectiveness of Dialectical Behavioral Therapy (DBT) Training and Aromatherapy Training (Lavender) on Psychological Symptoms of Pregnancy, indicators and Pain Intensity of the First and Second Stages of Childbirth and Competence for the role of Mother after Childbirth of Primiparous Women with Insecure Attachment to the Husband 2020-06-09 anticipated 75 Complete https://irct.ir/trial/49373 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomization method will be performed in a simple, individual random way, using a lottery and assigning each number to a patient. First, determine a total sample size of 75 people, then randomly assign a set of them to group A and set. Assign E to group B and the rest to group C. For example, 25 balls for group A and 25 balls for group B and 25 balls for group C are placed in the lottery container, then the balls are randomly removed from the container without replacement and the created sequence is recorded. N/A The effect of Lavender and Dialysis Behavior Therapy on delivery outcomes. Intervention 1: Intervention group: First, during pregnancy, dialysis behavior therapy sessions are presented in 10 sessions of 90 minutes by a doctor of psychology. During childbirth, dilation of 3-4 cm 5 drops in 1 liter of lavender essential oil water is used by inhalation, taking into account the private room for delivery, the administration of essential oil is repeated every 30 minutes. From the beginning of aromatherapy, the mother's pulse and blood pressure are monitored and also at the time of delivery, the duration of the first and second stages of labor, the severity of the mother's pain at the beginning of arrival, before 3-4 cm and 20 minutes after the onset of odor in dilation 5 7.8 at 10-10 cm, second stage of labor, neonatal Apgar score, fetal tachycardia and bradycardia, maternal demand for analgesia, maternal satisfaction with labor during labor, and overt anxiety also assessed by a trained researcher in the intervention group. Intervention 2: Intervention group: This group also started the active phase of labor from lavender essential oil made by Barij Essential Oil Company with a concentration of 1% in the form of 5 drops in 1 liter of water by inhaler with inhaler by considering a private room for labor. And delivery, from dilatation of 3-4 cm to the time of delivery is used and the administration of essential oil will be repeated every 30 minutes. One hour after starting aromatherapy, the mother's pulse and blood pressure are checked and also during delivery, the duration of the first and second stages. Delivery, the severity of maternal pain at arrival, before 3-4 cm and at 20 minutes after the onset of odor in dilatations 5-7 and at 8-10 cm, the second stage of labor, neonatal Apgar score, tachycardia and fetal bradycardia, Maternal demand for analgesia, maternal satisfaction with labor during labor, and overt anxiety will also be measured with the help of a trained researcher in the intervention group. Intervention 3: The intervention group of this group during childbirth with the beginning of the active phase of labor from lavender essential oil made by Barij Essential Oil Pharmaceutical Company with a concentration of 1% in the form of 5 drops in 1 liter of water by inhaler with inhaler taking into account the private room for labor and Delivery is used from dilatation of 3-4 cm until delivery and the administration of essential oil will be repeated every 30 minutes. One hour after starting aromatherapy, the mother's pulse and blood pressure are checked and also during labor, the duration of the first and second stages of labor. Intensity of maternal pain at arrival, before 3-4 cm and at 20 minutes after the onset of odor in dilatations 5-7 and at 8-10 cm, second stage of labor, neonatal Apgar score, tachycardia and fetal bradycardia, rate Maternal demand for analgesia, maternal satisfaction with labor during labor, and overt anxiety will also be measured with the help of a trained researcher in the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Elham_zameni
No. 93, Golchin 3., Ghaffari 18
Birjand Iran (Islamic Republic of) 9717963741 +98 56 3244 1097 elham_z2010@YAHOO.COM Islamic Azad University scientific Eham Zameni
No. 93, Golchin 3., Ghaffari 18
Birjand Iran (Islamic Republic of) 9717963741 +98 56 3244 1097 elham_z2010@YAHOO.COM Islamic Azad University Iran (Islamic Republic of) Primiparous Pregnant Women with Insecure Attachment to their Husbands no limit no limit Female Literacy Single Pregnancy Voluntary Natural Childbirth and no Medical reason for Cesarean section Lack of high-risk pregnancies such as Heart Disease, Preeclampsia, Diabetes, threat of Preterm Delivery ... Failure to participate in psychological Interventions in the last 6 Months Lack of Experience of Traumatic and Stressful Events in the last 6 Months Do not take Psychological Drugs No Allergies to Lavender and no Olfactory Problems N/A N/A Placebo Intervention group: First, during pregnancy, dialysis behavior therapy sessions are presented in 10 sessions of 90 minutes by a doctor of psychology. During childbirth, dilation of 3-4 cm 5 drops in 1 liter of lavender essential oil water is used by inhalation, taking into account the private room for delivery, the administration of essential oil is repeated every 30 minutes. From the beginning of aromatherapy, the mother's pulse and blood pressure are monitored and also at the time of delivery, the duration of the first and second stages of labor, the severity of the mother's pain at the beginning of arrival, before 3-4 cm and 20 minutes after the onset of odor in dilation 5 7.8 at 10-10 cm, second stage of labor, neonatal Apgar score, fetal tachycardia and bradycardia, maternal demand for analgesia, maternal satisfaction with labor during labor, and overt anxiety also assessed by a trained researcher in the intervention group. Intervention group: This group also started the active phase of labor from lavender essential oil made by Barij Essential Oil Company with a concentration of 1% in the form of 5 drops in 1 liter of water by inhaler with inhaler by considering a private room for labor. And delivery, from dilatation of 3-4 cm to the time of delivery is used and the administration of essential oil will be repeated every 30 minutes. One hour after starting aromatherapy, the mother's pulse and blood pressure are checked and also during delivery, the duration of the first and second stages. Delivery, the severity of maternal pain at arrival, before 3-4 cm and at 20 minutes after the onset of odor in dilatations 5-7 and at 8-10 cm, the second stage of labor, neonatal Apgar score, tachycardia and fetal bradycardia, Maternal demand for analgesia, maternal satisfaction with labor during labor, and overt anxiety will also be measured with the help of a trained researcher in the intervention group. The intervention group of this group during childbirth with the beginning of the active phase of labor from lavender essential oil made by Barij Essential Oil Pharmaceutical Company with a concentration of 1% in the form of 5 drops in 1 liter of water by inhaler with inhaler taking into account the private room for labor and Delivery is used from dilatation of 3-4 cm until delivery and the administration of essential oil will be repeated every 30 minutes. One hour after starting aromatherapy, the mother's pulse and blood pressure are checked and also during labor, the duration of the first and second stages of labor. Intensity of maternal pain at arrival, before 3-4 cm and at 20 minutes after the onset of odor in dilatations 5-7 and at 8-10 cm, second stage of labor, neonatal Apgar score, tachycardia and fetal bradycardia, rate Maternal demand for analgesia, maternal satisfaction with labor during labor, and overt anxiety will also be measured with the help of a trained researcher in the intervention group. Pregnancy depression. Timepoint: At the beginning of the Study and 35 Days after the start of the intervention. Method of measurement: Beck Depression Inventory. Pregnancy anxiety. Timepoint: At the beginning of the Study and 35 Days after the start of the intervention. Method of measurement: Wendenberg Pregnancy Anxiety Questionnaire. Maternal attachment to the fetus. Timepoint: At the beginning of the Study and 35 Days after the start of the intervention. Method of measurement: Maternal attachment questionnaire to Cranley fetus. Attachment to spouse. Timepoint: At the beginning of the Study and 35 Days after the start of the intervention. Method of measurement: Attachment Questionnaire to Fraley's wife, Waller and Brennan. Obvious anxiety score in the Spielberger questionnaire. Timepoint: At the beginning of the study and 35 days after the intervention and during labor and two weeks after delivery. Method of measurement: Spielberger Obvious Anxiety Questionnaire. Patience score in Khormai, Farmani and Soltani questionnaires. Timepoint: At the beginning of the study and 35 days after the intervention and two weeks after delivery. Method of measurement: Questionnaire of Patience of Date, Command and Soltani. Fear of childbirth score in Harman questionnaire. Timepoint: At the beginning of the study and 35 days after the start of the intervention. Method of measurement: Harman Maternity Fear Questionnaire. Postpartum Depression Score from the Edinburgh Questionnaire. Timepoint: Two weeks after delivery. Method of measurement: Edinburgh Postpartum Depression Inventory. Parental Competency Score from the Wallston-Gibbord Questionnaire. Timepoint: Two weeks after delivery. Method of measurement: Walston-Gibbord Parental Competency Score Questionnaire. Check the duration of labor. Timepoint: The active phase of the first stage of dilatation The duration of labor will be measured twice during 5-7 and 8-10 cm dilatations of the cervix. The second phase of labor is from dilatation of 10 cm of the cervix until the fetus leaves. Method of measurement: Through vaginal examinations. Evaluation of labor pain intensity. Timepoint: Evaluation of labor pain intensity before active phase and in the first and second stage of labor. Method of measurement: McGill Pain Pain Ruler. Birjand University of Medical Sciences Approved 2020-06-14 Ethics committee of Birjand University of Medical Sciences No. 93, Golchin 3., Ghaffari 18 Birjand South Khorasan Iran (Islamic Republic of)