CClinicalTrials.gg
CompletedNCT05169138Updated Dec 23, 2021

The Effect Of Lavender Essential Oil On Birth Pain

An interventional study of Aromatherapy application /massage with lavender oil and Aromatherapy application / inhalation with lavender oil in Labor Pain and Aromatherapy, sponsored by Near East University, Turkey. Completed at 1 site in Cyprus. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-23.

Sponsored by Near East University, Turkey · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2021, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

The study was planned as a randomized controlled trial to determine the effect of lavender oil applied to primiparous women by inhalation and massage methods on labor pain.

Read the detailed description

In universe of the research; Pregnant women who applied to Adana Seyhan State Hospital's Marsa Gynecology and Obstetrics Additional Service Building and Obstetrics Service and Delivery Room between the dates of the study, accepted to participate in the study voluntarily and who met the research conditions included. Numbers 1-2 of a 6-sided dice determined by the dice rolling system formed the control group (40 pregnant), numbers 3-4 were lavender oil inhalation group (44 pregnant), and numbers 5-6 were lavender oil massage group (37 pregnant).

The research was carried out in three stages for the experimental groups and control groups. First stage; Informed Voluntary Consent Form and Questionnaire were applied to the pregnant women whose groups were determined by the chosen randomization method. Afterwards, for the experimental groups according to the group; 10-minute training sessions were given on the inhalation method or massage method with aromatic lavender essential oil. In the second stage; Data were recorded by dividing the first phase of labor into 3 phases for each group. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied to the experimental groups 6 times, before and 30 minutes after the application. At this stage, no application was made in the control group, the Visual Analog Pain Scales and McGill Melzack Pain Questionnaire were applied at the beginning of each phase, the same forms were repeated after 30 minutes and the data were recorded 6 times in total. In the third stage; In the postpartum period, the study was completed by applying the Postpartum Period Information Collection Form by face-to-face interviews with the experimental groups and the pregnant women in the control group.

02

Conditions studied

  • Labor Pain
  • Aromatherapy

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Keywords

  • Labor Pain
  • Aromatherapy,
  • Lavender Essential Oil
  • Aromatherapy with lavender essential oil
03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 121 is above the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Near East University, Turkey is the lead sponsor of 44 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

INCLUSİON CRİTERİA:

  • Single pregnancy
  • Primiparous gestational age more than 36 weeks (term)
  • Cervical dilatation of at least 3 cm
  • Pregnants with 3 uterine contractions in a 10-minute period lasting at least 30 seconds
  • Cephalic presentation
  • Not receiving analgesics, sedatives or anesthetics during labor,
  • Not using induction at birth

EXCLUSİON CRİTERİA:

  • Multiparity
  • cephalopelvic incompatibility
  • third trimester bleeding history
  • intrauterine growth retardation
  • multiple pregnancy
  • breech presentation
  • subject's withdrawal from clinical trial
  • allergy to aromatic lavender essential oil
  • addiction (alcohol, smoking)
  • obstetric conditions requiring emergency cesarean section
  • infertility history
  • previous history of diagnosis of an underlying disease
  • induction at birth
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Care provider)
Enrollment
121 participants (actual)

Study arms

  • Placebo comparator
    massage group with lavender essential oil

    Pregnant women (n:37) who participated in this group were given an intense massage for at least 10 minutes in each phase during the first phase of labor. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied before and after the application, and the process was completed with a total of 6 measurements.

    Other: Aromatherapy application /massage with lavender oil

  • Placebo comparator
    group of inhalations with lavender essential oil

    Pregnant women (n:44) who participated in this group were administered inhalation with lavender oil at an intensity of at least 10 minutes in each phase during the first phase of labor. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied before and after the application, and the process was completed with a total of 6 measurements.

    Other: Aromatherapy application / inhalation with lavender oil

  • No intervention
    control group

    No application was made to the pregnant women (n:40) who participated in this group in each phase of the first phase of labor. Despite this, the Visual Analog Pain Scale and McGill Melzack Pain Questionnaire, which were applied at the beginning of each phase in order to increase the reliability of the results, were re-evaluated 30 minutes after the measurements, even though there was no application, and the process was completed with a total of 6 measurements.

Interventions

  • OtherAromatherapy application /massage with lavender oil

    The application was applied to 37 pregnant women in total, and the effect of massage with lavender oil on labor pain was investigated.

  • OtherAromatherapy application / inhalation with lavender oil

    The application was applied to 41 pregnant women in total, and the effect of inhalation with lavender oil on labor pain was investigated.

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale

    It is used to convert some values that cannot be measured numerically into numeric. Two extreme values of the parameter to be evaluated are written at the two ends of a 10 cm line, and the patient is asked to determine where his/her condition is appropriate on this line by drawing a line, putting a dot or placing any sign. For pain; "I have no pain" is written on one end and "very severe pain" is written on the other end and the patient is asked to mark the current situation on the line. The minimum score from the scale is 0, and the maximum score is 10. According to the scale, the highest pain value is expressed with 10 points, while 0 defines the least pain.

    Time frame: through study completion, an average of 9 month

  2. McGill Melzack Pain Questionnaire

    It is a multidimensional pain assessment tool consisting of four parts. At the entrance of the form, personal information of the patient, medical diagnosis-problem, introductory information to determine the location, characteristics, relationship and severity of pain according to the patient's perception are included. In the McGill Melzack pain questionnaire, the lowest score is 0 and the highest score is 112. 0 denotes the least pain level and the least pain-related discomfort, while 112 denotes the most severe pain and the most pain-related discomfort.

    Time frame: through study completion, an average of 9 month

  3. Questionnaire

    It was developed by the researcher as a result of literature review and includes 30 questions in total. It was aimed to collect information about the sociodemographic and obstetric anamnesis of pregnant women through the form.

    Time frame: through study completion, an average of 9 month

  4. Postpartum Period Data Collection Form

    It was developed by the researcher as a result of literature review and includes 21 questions in total. Via the form; It is aimed to collect information on labor, newborn characteristics, postpartum mother and baby interaction, and evaluation of mothers' satisfaction with massage or inhalation methods.

    Time frame: through study completion, an average of 9 month

07

Study locations

1 site
  • Near East University / Turkish Republic of Northern Cyprus
    Nicosia, Cyprus
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05169138
Lead sponsor
Near East University, Turkey
Responsible party
Seda Karatopuk (Assistant Lecturer, Near East University, Turkey) — Principal investigator
First posted
Dec 23, 2021
Start date
Jan 1, 2021
Primary completion
Sep 1, 2021
Completion
Nov 1, 2021
Last update
Dec 23, 2021

Study contacts

Filiz Yarıcı
study director · Study Director

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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