Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001000796
Ethics application status
Approved
Date submitted
23/06/2022
Date registered
15/07/2022
Date last updated
15/07/2022
Date data sharing statement initially provided
15/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of aromatherapy on levels of anxiety, pain and maternal-fetal physiological parameters in pregnant women: AromaGest study
Scientific title
Impact of aromatherapy on levels of anxiety, pain and maternal-fetal physiological parameters in pregnant women: AromaGest study
Secondary ID [1] 307351 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antenatal anxiety 326646 0
Antenatal pain 326647 0
Condition category
Condition code
Mental Health 323888 323888 0 0
Anxiety
Alternative and Complementary Medicine 323889 323889 0 0
Other alternative and complementary medicine
Reproductive Health and Childbirth 323890 323890 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323783 0
Treatment: Other
Intervention code [2] 323863 0
Behaviour
Comparator / control treatment
For the control group: Simulated aromatherapy using diffusers with distilled water. Aromatherapy with distilled water will be used on two occasions: (1) during cardio-fetal follow-up and (2) coinciding with the start of the labor dilatation period.
The duration of the simulated aromatherapy will be 20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 331732 0
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.
Timepoint [1] 331732 0
Cardiac-fetal monitoring session: immediately before and after aromatherapy is administered
Labor dilatation period: immediately before and after aromatherapy is administered
Primary outcome [2] 331796 0
Pain: The Visual Analog Scale (VAS)
Timepoint [2] 331796 0
Pain: immediately before and after aromatherapy is administered
Secondary outcome [1] 410890 0
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).
Timepoint [1] 410890 0
Assessed 5 minutes after starting the test and 5 minutes after finishing the cardiac-fetal monitoring.
Secondary outcome [2] 410891 0
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).
Timepoint [2] 410891 0
Assessed 5 minutes after starting the test and 5 minutes after finishing the cardiac-fetal monitoring.
Secondary outcome [3] 410892 0
Change on basal fetal heart rate (BFHR), assessed using the cardiac fetal monitoring, during the interventions (aromatherapy).
Timepoint [3] 410892 0
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.
Secondary outcome [4] 410893 0
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.
Timepoint [4] 410893 0
Assessed just once, 2 months after last routine cardiac-fetal monitoring check.
Secondary outcome [5] 410894 0
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.
Timepoint [5] 410894 0
Assessed just once, 2 months after last routine cardiac-fetal monitoring check.
Secondary outcome [6] 410895 0
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.
Timepoint [6] 410895 0
Assessed just once, 2 months after last routine cardiac-fetal monitoring check.
Secondary outcome [7] 410896 0
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.
Timepoint [7] 410896 0
Assessed just once, 2 months after last routine cardiac-fetal monitoring check.
Secondary outcome [8] 410897 0
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.
Timepoint [8] 410897 0
Assessed just once, 2 months after last routine cardiac-fetal monitoring check.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) obstetric or medical complications of pregnancy that prevented vaginal delivery
(2) maternal smell problems
(3) multiple gestations
(4) women with mental health problems
(5) who do not want to voluntarily participate in the study .

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
182
Accrual to date
Final
Recruitment outside Australia
Country [1] 24843 0
Spain
State/province [1] 24843 0
Lorca (Mucia)

Funding & Sponsors
Funding source category [1] 311639 0
Hospital
Name [1] 311639 0
Hospital Rafael Mendez
Country [1] 311639 0
Spain
Primary sponsor type
Hospital
Name
Hospital Rafael Mendez
Address
Ctra. Nacional 340, Km. 589
30817
Lorca (Murcia)
Country
Spain
Secondary sponsor category [1] 313078 0
None
Name [1] 313078 0
None
Address [1] 313078 0
None
Country [1] 313078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311095 0
Health Ethics and Research Committee Area III
Ethics committee address [1] 311095 0
Ctra. Nacional 340, Km. 589
30817 Lorca
Murcia
Ethics committee country [1] 311095 0
Spain
Date submitted for ethics approval [1] 311095 0
Approval date [1] 311095 0
05/05/2022
Ethics approval number [1] 311095 0
CEI-2022-04-21

Summary
Brief summary
Introduction: Anxiety has a negative influence on the pregnant woman and the fetus, and can cause misleading readings of tests such as fetal cardiotocography and the active period of labor, and influence aspects related to childbirth and pain management. Aromatherapy is a complementary and alternative therapy that generates well-being and allows the mind and body to be treated in a natural way.
Objective: to evaluate the role of aromatherapy in reducing anxiety levels, its maternal-fetal benefits, and its influence on the labor process and pain management.
Methods: triple-blind randomized clinical trial. The minimum sample size will be 182 full-term and first-time pregnant women, divided into two groups, an intervention group with lavender essence aromatherapy (n=91) and a control group with simulated aromatherapy with distilled water (n=91). Anxiety levels will be measured using Spielberger State-Trait Anxiety Inventory (STAI), physiological parameters of the mother and fetus, and parameters related to the first stage of labor and the degree of pain (VAS scale).
Expected results: pregnant women undergoing aromatherapy are expected to have lower levels of anxiety compared to the control group during fetal cardiotocography. Physiological parameters of the mother and fetus and the delivery process and pain management will also improve in the intervention group.
Relevance for Health Welfare: There are processes that generate anxiety in pregnant women during the third trimester of pregnancy, such as fetal cardiotocography and the first stage of labor. Midwives can apply non-invasive, non-pharmacological complementary techniques, such as aromatherapy, to promote physio-psychological comfort in women during pregnancy, childbirth and postpartum.
Keywords: anxiety; aromatherapy; wellness; pregnancy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119926 0
Prof Jessica Garcia-Gonzalez
Address 119926 0
Calle Universidad de Almería, Carr. Sacramento, s/n, 04120 La Cañada, Almería
Country 119926 0
Spain
Phone 119926 0
+34950214442
Fax 119926 0
Email 119926 0
jgg145@ual.es
Contact person for public queries
Name 119927 0
Prof Raquel Alarcon-Rodriguez
Address 119927 0
Calle Universidad de Almería, Carr. Sacramento, s/n, 04120 La Cañada, Almería
Country 119927 0
Spain
Phone 119927 0
+34950214606
Fax 119927 0
Email 119927 0
ralarcon@ual.es
Contact person for scientific queries
Name 119928 0
Prof Mar Requena-Mullor
Address 119928 0
Calle Universidad de Almería, Carr. Sacramento, s/n, 04120 La Cañada, Almería
Country 119928 0
Spain
Phone 119928 0
+34950214608
Fax 119928 0
Email 119928 0
mrm047@ual.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.