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IRCT20231212060342N1 IRCT 2023-12-29 Shiraz University of Medical Sciences Comparative the effect of auriculotherapy and aromatherapy with Citrus aurantium aroma on intensity of labour pain and some variables of maternal and neonatal outcomes in primiparous women: A Double Blinded Randomized Controlled Trial Comparative the effect of auriculotherapy and aromatherapy with Citrus aurantium aroma on intensity of labour pain and some variables of maternal and neonatal outcomes in primiparous women: A Double Blinded Randomized Controlled Trial 2023-12-30 anticipated 138 Complete https://irct.ir/trial/74435 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For randomization, permutation block method will be used to allocate samples to three groups (no intervention - auriculotherapy group - aromatherapy group) , 138 samples will be placed in 23 blocks of 6. Random allocation list is provided by Random software, Blinding description: In the aromatherapy group, gauze impregnated with 4 drops of citrus aurantium aroma (Adonis Gol Daru Company-Iran) will be attached to the neck of the participants. gauzes will be changed every 30 minutes until the cervix has reached 10 centimeters dilation. In addition, in order to avoid bias, for all participants in the aromatherapy group, grain-free adhesives will be applied on four unrelated points (ankle, knee, tooth and jaw) of both ears. Then every 30 minutes in between uterus contraction, a gentle palpation is placed on one of the ears by the project manager, but these points will not be pressed. In the auriculotherapy group, pressure on the main points of the ear in the external ear (point zero, shen men, sympathetic, thalamus) with the aim of reducing pain and anxiety and the primary points of the ear (uterus (C), uterus (E), Gonadotrophins, ovaries, pelvis , abdomen) with the aim of reducing pain and helping the progress of labor, is applied by a trained researcher who has completed the preliminary auriculotherapy course in 22 hours under the supervision of the Iranian Midwifery Association. To avoid creating bias, auriculotherapy is performed by one person for all research subjects. First, the right ear is cleaned using alcohol, pressure is applied using adhesives containing vacaria seeds for auriculotherapy by ZhongyanTaihe Company, which is available in the Iran, for 30 seconds between contractions, and finger pressure is applied on the vacaria seeds. After 30 minutes, the same points in the left ear are pressed for 30 seconds between contractions, and with finger pressure on the Vacaria seeds. The seeds are compressed alternately on the right and left ear every 30 minutes and each time for 30 seconds until the time of dilation of 10 cm. Finger pressure on the seeds to the extent that the pain is tolerable for the samples. In order to avoid bias, in the auriculotherapy group, a moisten gauze with 4 drops of distilled water will be attached to the collar of all participants. gauzes will be changed every 30 minutes until 10 cm dilation For all participants in the control group, seedless adhesives will be applied on four unrelated points (ankle, knee, tooth and jaw) of both ears. Then, every 30 minutes, a gentle hand is placed on one of their ears, but these points will not be pressed. In addition, for all participants in this group, gauze soaked with 4 drops of distilled water will be attached to their collars. Gauzes will be changed every 30 minutes until 10 cm dilation. Also, all three groups will receive the usual maternity care. For blinding, the outcome evaluator and the participants will not be informed of which group each sample belongs to, and only the project manager who performs the necessary interventions in the labor and delivery room will know about the groups. 3 Condition 1: Labor pain intensity. Condition 2: Labor anxiety. Condition 3: Active phase length of delivery. Intervention 1: Intervention group: In the aromatherapy group, gauze impregnated with 4 drops of Citrus aurantium aroma (Adonis Gol Daru Company-Iran) will be attached to the participants' collars. Gauzes will be changed every 30 minutes until 10 cm dilation. In addition, in order to avoid bias, for all participants in the aromatherapy group, grain-free adhesives will be applied on four unrelated points (ankle, knee, tooth and jaw) of both ears. Then every 30 minutes and between uterine contractions, a gentle hand is placed on their ears, but these points will not be pressed. Intervention 2: Intervention group: In the auriculotherapy group, pressure on the main points of the ear in the external ear (point zero, shen men, sympathetic, thalamus) with the aim of reducing pain and anxiety and the primary points of the ear (uterus (C), uterus (E), Gonadotrophins, ovaries, pelvis, abdomen) ) with the aim of reducing pain and helping the progress of labor, is applied by a trained researcher who has completed the preliminary course of auriculotherapy in 22 hours under the supervision of the Iranian Midwifery Scientific Association. To prevent torsion, ericulotherapy is performed by one person for all research samples. First, the ears are cleaned using alcohol and is applied adhesives containing vacaria seeds for auriculotherapy by ZhongyanTaihe Company, which is available in the Iran . For 30 seconds between contractions, and finger pressure is applied on the vacaria seeds of right ear. After 30 minutes, the same points in the left ear are pressed for 30 seconds between contractions, and with finger pressure on the Vacaria seeds. The seeds are compressed alternately on the right or left ear every 30 minutes and each time for 30 seconds until the full dilation. Finger pressure on the seeds to the extent that the pain is bearable for the client. In order to avoid bias, in the auriculotherapy group, gauze impregnated with 4 drops of distilled water will be attached to the collar of all participants. Gauzes will be changed every 30 minutes until 10 cm dilation. Intervention 3: Control group: For all participants in the control group, seedless adhesives will be applied on four unrelated points (ankle, knee, tooth and jaw) of both ears. Then, every 30 minutes, a gentle hand is placed on one of their ears, but these points will not be pressed. In addition, for all participants in this group, a gauze soaked with 4 drops of distilled water will be attached to their collars. Gauzes will be changed every 30 minutes until 10 cm dilation. 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 There is no further information.
public Fatane Eeftekhari Shah Abad
The second door on the left, the second dead end on the right, Arash Ik Alley, Forty Alley, Ayatollah Khamenei Blvd., Yazd City
Yazd Iran (Islamic Republic of) 8916163468 +98 35 3821 3003 eftekhary.fatane@gmail.com Shiraz University of Medical Sciences scientific Mahboubeh Hajifoghaha
Faculty of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz
Shiraz Iran (Islamic Republic of) ۷۱۹۳۶۱۳۱۱۹ +98 71 3647 4254 Foghaha2000@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iranian women Prim parous women Having minimum literacy that is able to read and write Term pregnancy Singleton pregnancy with an alive fetus A fetus with cephalic presentation A fetus with an approximate weight of less than 4 kg Start of spontaneous labor contractions 4 cm dilation of the cervix A pelvis with suitable dimeters for childbirth Intact amniotic membranes Written Informed consent to participate in this study Bilateral external ear without any lesion (mass, swelling, infection or wound) for doing auriculotherapy 18 years 35 years Female Use of painkillers in the last eight hours Using any complementary or traditional medicines to start labor pain Diagnosed liver, gall bladder or respiratory diseases Chronic diabetes or gestational diabetes Olfactory disorders in the aromatherapy group Allergy to herbal medicines for the aromatherapy group Allergy to Citrus aurantium in the aromatherapy group Pregnancy complications (such as pre-eclampsia, chorioamnionitis, placental abruption and abnormal fetal heart rate, etc.) O94-O99 O94-O99 O80-O84 Other obstetric conditions, not elsewhere classified Other obstetric conditions, not elsewhere classified Delivery Treatment - Other Treatment - Other Treatment - Other Intervention group: In the aromatherapy group, gauze impregnated with 4 drops of Citrus aurantium aroma (Adonis Gol Daru Company-Iran) will be attached to the participants' collars. Gauzes will be changed every 30 minutes until 10 cm dilation. In addition, in order to avoid bias, for all participants in the aromatherapy group, grain-free adhesives will be applied on four unrelated points (ankle, knee, tooth and jaw) of both ears. Then every 30 minutes and between uterine contractions, a gentle hand is placed on their ears, but these points will not be pressed. Intervention group: In the auriculotherapy group, pressure on the main points of the ear in the external ear (point zero, shen men, sympathetic, thalamus) with the aim of reducing pain and anxiety and the primary points of the ear (uterus (C), uterus (E), Gonadotrophins, ovaries, pelvis, abdomen) ) with the aim of reducing pain and helping the progress of labor, is applied by a trained researcher who has completed the preliminary course of auriculotherapy in 22 hours under the supervision of the Iranian Midwifery Scientific Association. To prevent torsion, ericulotherapy is performed by one person for all research samples. First, the ears are cleaned using alcohol and is applied adhesives containing vacaria seeds for auriculotherapy by ZhongyanTaihe Company, which is available in the Iran . For 30 seconds between contractions, and finger pressure is applied on the vacaria seeds of right ear. After 30 minutes, the same points in the left ear are pressed for 30 seconds between contractions, and with finger pressure on the Vacaria seeds. The seeds are compressed alternately on the right or left ear every 30 minutes and each time for 30 seconds until the full dilation. Finger pressure on the seeds to the extent that the pain is bearable for the client. In order to avoid bias, in the auriculotherapy group, gauze impregnated with 4 drops of distilled water will be attached to the collar of all participants. Gauzes will be changed every 30 minutes until 10 cm dilation. Control group: For all participants in the control group, seedless adhesives will be applied on four unrelated points (ankle, knee, tooth and jaw) of both ears. Then, every 30 minutes, a gentle hand is placed on one of their ears, but these points will not be pressed. In addition, for all participants in this group, a gauze soaked with 4 drops of distilled water will be attached to their collars. Gauzes will be changed every 30 minutes until 10 cm dilation Labor pain intensity. Timepoint: The intensity of labor pain in all three groups will be measured at 4 cm dilatation (before the start of the intervention) and 20 minutes after the start of the intervention at 4 cm dilation as well as at 6 and 8 cm. Method of measurement: To determine the intensity of labor pain, the visual analog scale of pain measurement (VAS) will be used. Anxiety. Timepoint: The intensity of anxiety in all three groups will be measured at 4 cm dilation (before the start of the intervention) and 20 minutes after the start of the intervention at 4 cm dilation, as well as at 6 and 8 cm. Method of measurement: The intensity of anxiety will be measured with the Spielberger state-trait anxiety questionnaire. The length of the active phase. Timepoint: The time interval between4 cm dilatation to full cervical dilatation in the presence of at least 2 contractions in 10 minutes will be calculated based on hours and minutes during labor. Method of measurement: In order to measure the length of the active phase of labor, the partograph diagram is drawn in the delivery room and the length of the active phase of labor will be calculated by the researcher. Length of the second stage of labor. Timepoint: The length of this stage will be measured by the researcher by measuring the time interval between the complete dilatation of the cervix and the exit of the fetus in minutes. Method of measurement: The length of this stage will be measured by the researcher with measuring the time of between the complete dilatation of the cervix and the exit of the fetus in minutes. Apgar Score. Timepoint: Apgar score will be calculated in the first and fifth minutes after birth. Method of measurement: The Apgar table will be used to calculate the Apgar score. Shiraz University of Medical Sciences Approved 2023-10-28 Research Ethics Committees of Schools of Nursing and Midwifery, Management and Medical Information s Faculty of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz Shiraz Fars Iran (Islamic Republic of)