Impact of aromatherapy on levels of anxiety, pain and maternal-fetal physiological parameters in pregnant women: AromaGest study

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: Randomized clinical trial with 182 full‐term pregnant women divided into two groups during their cardio‐fetal follow‐up in the hospital: aromatherapy intervention group (n = 91) and control group (n = 91). The intervention group will receive aromatherapy with dispensers containing 100% pure lavender oil essence (4 drops in 300 ml of distilled water). The second midwife, blinded to the intervention, will perform a 20‐minute fetal cardiac monitoring and will attend to the pregnant women during the dilation period prior to delivery. Aromatherapy will be used on two occasions: (1) during cardio‐fetal follow‐up and (2) coinciding with the start of the labor dilatation period. The 20‐minute fetal cardiac monitoring will begin at the same time as aromatherapy. The midwife who will apply environmental aromatherapy to pregnant women at term will be responsible for monitoring adherence to the intervention. The duration of the aromatherapy session will be 20 minutes. CONDITION: Alternative and Complementary Medicine ‐ Other alternative and complementary medicine Antenatal anxiety;Antenatal pain; ; Antenatal anxiety ; Antenatal pain Mental Health ‐ Anxiety Reproductive Health and Childbirth ‐ Antenatal care PRIMARY OUTCOME: Change in pregnant women's anxiety levels during cardiac‐fetal monitoring and the start of the labor dilatation period, measured by State‐Trait Anxiety Inventory (STAI) test, before starting it and after finish it, on interventional group and control group.[Cardiac‐fetal monitoring session: immediately before and after aromatherapy is administered; Labor dilatation period: immediately before and after aromatherapy is administered] Pain: The Visual Analog Scale (VAS)[Pain: immediately before and after aromatherapy is administered] INCLUSION CRITERIA: (1) pregnant women of legal age (2) nulliparous (3) term pregnancy (4) without comorbidities (gestational diabetes, eclampsia, preeclampsia, COPD) (5) low‐risk singleton pregnancy (6) cephalic presentation (7) vaginal delivery. SECONDARY OUTCOME: Change in the beginning of labor in pregnant women who have undergone aromatherapy during their last routine cardiac‐fetal monitoring check and during the delivery process. It will be checked by reviewing their medical history.[Assessed just once, 2 months after last routine cardiac‐fetal monitoring check.] Change in the duration of dilation time in pregnant women who have undergone aromatherapy during their last routine cardiac‐fetal monitoring check and during the delivery process. It will be checked by reviewing their medical history.[Assessed just once, 2 months after last routine cardiac‐fetal monitoring check.] Change in the episiotomy/tear rate in pregnant women who have undergone aroma therapy during their last routine cardiac‐fetal monitoring check and during the delivery process. It will be checked by reviewing their medical history.[Assessed just once, 2 months after last routine cardiac‐fetal monitoring check.] Change in the presentation of the baby in pregnant women who have undergone aromatherapy during their last routine cardiac‐fetal monitoring check and during the delivery process. It will be checked by reviewing their medical history.[Assessed just once, 2 months after last routine cardiac‐fetal monitoring check.] Change in the termination of labor in pregnant women who have undergone aromatherapy during their last routine cardiac‐fetal monitoring check and during the delivery process. It will be checked by reviewing their medical history.[Assessed just once, 2 months after last routine cardiac‐fetal monitoring check.] Change on basal fetal heart rate (BFHR), assessed using the cardiac fetal monitoring, during the interventions (aromatherapy).[Assessed 5 minutes after starting the test, to assess the fetal heart rate (FHR) and 5 minutes before finishing the cardiac‐fetal monitoring, to evaluate the basal fetal heart rate (BFHR) during the test.] Change on term pregnant women's blood pressure levels (measured using a sphygmomanometer) before and after interventions (aroma therapy) during the cardiac‐fetal monitoring (CFM): Systolic blood pressure (SBP) and Diastolic blood pressure (DBP).[Assessed 5 minutes after starting the test and 5 minutes after finishing the cardiac‐fetal monitoring.] Change on term pregnant women's heart rate (HR), assessed using a pulse oximeter, before and after interventions (aroma therapy) during the cardiac‐fetal monitoring (CFM).[Assessed 5 minutes after starting the test and 5 minutes after finishing the cardiac‐fetal monitoring.]
Epistemonikos ID: fd7feced9a72dae2ea68767ee16966191525336a
First added on: Aug 25, 2024