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IRCT20230301057585N1 IRCT 2023-03-10 Gonabad University of Medical Sciences Comparison of the effect of aromatherapy with lavender and clove essential oil on labor pain and anxiety Comparison of the effect of lavender and clove essential oil on the intensity of pain and anxiety of the first stage of labor 2023-04-04 anticipated 159 Complete https://irct.ir/trial/68987 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples of this study are selected using an easy and accessible sampling method And to allocate the samples to the studied groups, the block random allocation method will be used.For this purpose, the "blockran" package was used in R statistical software.In the relevant function in this package, the number of treatments was 3 and the volume of the block was 6, and then the studied samples were assigned to groups using the random sequence generated by the random blocks of 6, Blinding description: In this study, the participants are aware of the intervention, but they do not know the type of essential oil they are prescribed (lavender, clove or distilled water). 3 pain and anxiety of the first stage of labor. Intervention 1: First Intervention group: Aromatherapy with lavender essential oil with a concentration of 2% was purchased from Barich Essential Oil Company, which is impregnated with gas to the extent of 0.2 cc and attached to the collar of the participants' clothes, and its prescription is repeated every 15 minutes, and they are asked to breathe normally. Intervention 2: Second Intervention group: Aromatherapy with clove essential oil with a concentration of 2% was purchased from Barich Essential Oil Company, which is impregnated with gas to the extent of 0.2 cc and attached to the collar of the participants' clothes, and its prescription is repeated every 15 minutes, and they are asked to breathe normally. Intervention 3: Control group: In the control group, 0.2 cc of distilled water is impregnated with gas and attached to the collar of the participants' clothes, and its prescription is repeated every 15 minutes, and they are asked to breathe normally. Yes - There is a plan to make this available What will be shared: Information on main outcomes in participant data after de-identification of individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The necessary conditions for requesting data include the applicant's profile, the reason for the request, and how to use it.Then the requested items are sent with the opinion of the authors. Where to obtain: NiloofarAhmadi97@gmail.com 09151087996 Niloofar SadeghAhmadi How to obtain: After the applicant's request, the data will be sent via email within 15 days. Comments:
public Niloofar SadeghAhmadi
No. 514, North Building, Parsian Tower, Amoozegar 37 Ave, Amoozegar Blvd, Mashhad Town
Mashhad Iran (Islamic Republic of) 9188173282 +98 51 3864 9954 Niloofarahmadi97@gmail.com Gonabad University of Medical Sciences scientific Niloofar SadeghAhmadi
No. 514, North Building, Parsian Tower, Amoozegar 37 Ave, Amoozegar Blvd, Mashhad Town
Mashhad Iran (Islamic Republic of) 9188173282 +98 51 3864 9954 Niloofarahmadi97@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women with first and second pregnancy, aged 18-35 years, pregnant with single fetus , having a normal delivery, 38-42 weeks of pregnancy, cephalic presentation, cervical dilatation more than 3 cm. No history of asthma, sensitivity and allergy according to mother's statements. Absence of disease and complications of pregnancy and obstetrics (such as: pre-eclampsia - chorioamnionitis - known liver, gallbladder and respiratory disease, decollement and abnormal heartbeat of the fetus at the beginning of the study), Not having smell problems and allergies to herbal medicines according to the person. Not having a known anxiety and depression disease according to the person's statements in the medical history and the mother's file. Not having migraines according to the mother's statements in the medical history. Not receiving medical painkillers 3 hours before the start of the study. There is no history of infertility and thyroid disease according to the person's statements in the medical history and the mother's file. Informed consent of women to participate in the study 18 years 35 years Female Mother's non-cooperation in completing the checklist and expressing her pain Departure from the natural course of labor Having an emergency caesarean section Allergic to essential oil Fetal weight less than 2.5 kg or more than 4 kg Treatment - Drugs Treatment - Drugs Treatment - Drugs First Intervention group: Aromatherapy with lavender essential oil with a concentration of 2% was purchased from Barich Essential Oil Company, which is impregnated with gas to the extent of 0.2 cc and attached to the collar of the participants' clothes, and its prescription is repeated every 15 minutes, and they are asked to breathe normally. Second Intervention group: Aromatherapy with clove essential oil with a concentration of 2% was purchased from Barich Essential Oil Company, which is impregnated with gas to the extent of 0.2 cc and attached to the collar of the participants' clothes, and its prescription is repeated every 15 minutes, and they are asked to breathe normally. Control group: In the control group, 0.2 cc of distilled water is impregnated with gas and attached to the collar of the participants' clothes, and its prescription is repeated every 15 minutes, and they are asked to breathe normally. Labor Pain score. Timepoint: At the beginning of the study, dilation 4-5 cm , dilatation 8-10 cm. Method of measurement: Visual Analogue Scale (VAS). Anxiety score. Timepoint: At the beginning of the study, dilation 4-5 cm , dilatation 8-10 cm. Method of measurement: Spielberger anxiety questionnaire. Gonabad University of Medical Sciences Approved 2023-02-13 Ethics committee of Gonabad University of Medical Sciences No. 514, North Building, Parsian Tower, Amoozegar 37 Ave, Amoozegar Blvd, Mashhad City Mashhad Razavi Khorasan Iran (Islamic Republic of)