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IRCT20100414003706N39 IRCT 2021-08-23 Tabriz University of Medical Sciences Comparison of epidural analgesia and aromatherapy with lavender regarding fear of childbirth Fear of childbirth in epidural analgesia and aromatherapy with lavender: a randomized two-arm parallel-group trial 2021-09-05 anticipated 56 Complete https://irct.ir/trial/57640 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be individually randomized into intervention or control groups using stratified (previous history of labor and type of labor onset (spontaneous or induction)) block randomization with block size of four and six. Allocation sequence will be determined using a computerized program (www.random.org). Sequentially numbered opaque sealed envelopes will be used to conceal the allocation. Allocation sequence and the envelopes will be prepared by a person not involved in participant recruitment and allocation, or data collection. 3 Fear during and after childbirth. Intervention 1: Intervention group 1: In the epidural group, the injection will be performed by an anesthesiologist according to the national protocol for painless delivery, and with the intermittent injection technique. In this technique, depending on the patient's needs and pain, 5 to10 milliliter of bupivacaine 0.125 to 0.625% or rupivacaine 0.1 to 0.2% will be repeated every 30 to 60 minutes. Intervention 2: Intervention group 2: In the aromatherapy group, a piece of linen cloth (with length and width about 15 centemeter), impregnated with 0.1 milliliter of lavender essential oil prepared by Barij Essential Oil Company, diluted with 1 milliliter of distilled water, is placed on the patient's neck. Linen fabric is used to preserve the scent and the skin does not absorb the essential oil and prevent complications. Fabrics will be stored in sterile conditions. Yes - There is a plan to make this available What will be shared: Requested data will be provided to researchers for statistical analysis (meta- analysis) of the submitted proposal. When: starting immediately after publication of the study results To whom: Data will be available to researchers working at academic organizations, as well as to chief editor (and reviewers) of the journal of the submitted manuscript/s, if requested. Conditions: The data will be available to researchers upon request and submission of a proposal to perform meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to journal of submitted manuscript/s for checking accuracy of the dat Where to obtain: Refer to the email address (alizades@tbzmed.ac.ir; mhammadalizadehs@gmail.com) How to obtain: The requests will be sent by email and data will be available within a week. Comments:
public Zohreh Zakavi
Nursing & Midwifery Faculty, South Shariati Ave., Tabriz
Tabriz Iran (Islamic Republic of) 59691-15868 +98 44 4436 3557 zohreh.zakavi.92@gmail.com Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh-Charandabi
Faculty of Nursing & Midwifery, South Shariati Ave., Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6969 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Have a healthy sense of smell Age 18 to 45 years First to third childbirth Live single fetus with cephalic presentation Gestational age 37 to 41 weeks regular labor contractions Cervical dilatation 4 to 5 cm No received sedation in 4 hours prior to intervention Having a low-risk pregnancy (absence of third trimester bleeding, placental abruption, placenta previa, fetal growth disorder, etc.) 18 years 45 years Female Any surgery on the uterus including cesarean section Any contraindications to vaginal delivery including Cephalopelvic disproportion (CPD) Abnormal amniotic fluid volume Any contraindications to receive epidural analgesia or aromatherapy, including a history of allergies to herbal or analgesic drugs Pregnancy with the help of assisted reproductive techniques (ART) Any major physical or mental illness Severe obesity (Body mass index (BMI) higher than 35 kilograms per square meter) Unwillingness to participate in the study or the inability to obtain informed consent from the person, including having excessive anxiety or stress Non-reactive fetal heart rate F40.232 Fear of other medical care Other Treatment - Other Intervention group 1: In the epidural group, the injection will be performed by an anesthesiologist according to the national protocol for painless delivery, and with the intermittent injection technique. In this technique, depending on the patient's needs and pain, 5 to10 milliliter of bupivacaine 0.125 to 0.625% or rupivacaine 0.1 to 0.2% will be repeated every 30 to 60 minutes. Intervention group 2: In the aromatherapy group, a piece of linen cloth (with length and width about 15 centemeter), impregnated with 0.1 milliliter of lavender essential oil prepared by Barij Essential Oil Company, diluted with 1 milliliter of distilled water, is placed on the patient's neck. Linen fabric is used to preserve the scent and the skin does not absorb the essential oil and prevent complications. Fabrics will be stored in sterile conditions. Childbirth fear. Timepoint: One and two hours after intervention. Method of measurement: Delivery Fear Scale. Severity of postpartum fear. Timepoint: Two hours and 5 weeks after delivery. Method of measurement: Wijma Version B scale. Pain intensity. Timepoint: At 4 to 5 cm cervical dilatation (just before intervention), 30 minutes after the intervention and then every hour until delivery. Method of measurement: Visual analog scale. Childbirth experience satisfaction. Timepoint: 12 to 24 hours after delivery. Method of measurement: Birth satisfaction scale-revised questionnaire. Duration of the first, second and third stages of labor and intervention until delivery. Timepoint: beginning to the end of intervention. Method of measurement: Partograph. Emergency cesarean section. Timepoint: beginning to the end of intervention. Method of measurement: Researcher observation. Tabriz University of Medical Sciences Approved 2021-08-02 Ethics committee of Tabriz University of Medical Sciences No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Ave., Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)