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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231212060342N1
Enrollment
138
Registered
2023-12-29
Start date
2023-12-30
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Labor pain intensity. Condition 2: Labor anxiety. Condition 3: Active phase length of delivery. Other obstetric conditions, not elsewhere classified Other obstetric conditions, not elsewhere classified Delivery

Interventions

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. Ga

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.)

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatane Eeftekhari Shah Abad

Shiraz University of Medical Sciences

eftekhary.fatane@gmail.com+98 35 3821 3003

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026