The Effect of Ylang Ylang Oil and Lemon Oil (Aromatherapy)

December 10, 2022 updated by: Özlem Çağan

The Effect of Ylang Ylang Oil and Lemon Oil Inhalation on Active Phase Labor Pain and Anxiety in Primiparous Pregnant Women

This study was conducted as a randomized controlled experimental study.To evaluate the effects of aromatherapy, one of the non-pharmacological pain methods, on labor pain and anxiety in the active phase in primiparous pregnant women.

The main questions it aims to answer are:

Is ylang ylang oil applied as an inhaler effective in reducing labor pain and anxiety? Is lemon oil applied as an inhaler effective in reducing labor pain and anxiety? Participants randomized according to the closed envelope method into the lemon oil group (n=15), ylang ylang oil group (n=15) and control group (n=15). In the active phase (cervical dilatation ≥5), a drop of essential oil was instilled onto square cotton balls to the intervention groups and renewed as one drop every hour until labor occurred. In the control group, 1 drop of saline was dripped onto square cotton balls. Visual pain scale (VAS) and state anxiety ınventory were applied to the intervention groups and control groups before the application. After the application, VAS and state anxiety ınventory were evaluated at 5-7 cm dilatation, and only with VAS at 8-10 cm dilatation. The trait anxiety ınventory was administered to the volunteers after birth.

Study Overview

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Etlik Zübeyde Hanim Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Term pregnancy (37-41 weeks)
  • Pregnant women between the ages of 18-35
  • had singleton pregnancy with cephalic presentation of the fetus
  • Not allergic to ylang ylang oil, flower/lemon or oil or anything
  • Absence of any pregnancy complications
  • No previous miscarriage, no abortion
  • Not having any diagnosed systemic disease
  • ≥ 5 cm (cm) (active phase) cervical dilatation
  • Pregnant women who do not take any analgesia, anesthesia or anxiolytic drugs
  • Spontaneous onset of labor
  • Pregnant women who can speak and write Turkish well
  • Pregnant woman's consent to participate in the study.

Exclusion Criteria:

  • Emergency cesarean section indication
  • Use of analgesic, anesthetic and anxiolytic drugs by the pregnant woman
  • The pregnant woman's desire to withdraw from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1 (Ylang ylang oil)
A square cotton ball impregnated with a drop of ylang-ylang oil was placed in the participants randomized to group I (cervical dilatation ≥ 5) with the help of safety pins of pregnant women. One hour after the intervention (in the range of 5-7 cm cervical dilatation), pain levels were measured again with the VAS and anxiety levels were measured with the State Anxiety Scale. The essential oil was renewed as 1 drop every hour until the birth of the baby. When cervical dilatation was in the range of 8-10 cm, pain level was re-evaluated only with VAS. Spielberger Continuity Anxiety Scale was applied with face-to-face interview technique within 4-24 hours following the birth.
inhaler aromatherapy
Experimental: group 2 (Lemon oil)
A square cotton ball impregnated with a drop of lemon oil was placed in the participants randomized to group 2 (cervical dilatation ≥ 5) with the help of safety pins of pregnant women. One hour after the intervention (in the range of 5-7 cm cervical dilatation), pain levels were measured again with the VAS and anxiety levels were measured with the State Anxiety Scale. The essential oil was renewed as 1 drop every hour until the birth of the baby. When cervical dilatation was in the range of 8-10 cm, pain level was re-evaluated only with VAS. Spielberger Continuity Anxiety Scale was applied with face-to-face interview technique within 4-24 hours following the birth.
inhaler aromatherapy
Placebo Comparator: group 3 (Control)
A square cotton ball impregnated with a drop of salin was placed in the participants randomized to group I (cervical dilatation ≥ 5) with the help of safety pins of pregnant women. One hour after the intervention (in the range of 5-7 cm cervical dilatation), pain levels were measured again with the VAS and anxiety levels were measured with the State Anxiety Scale. The essential oil was renewed as 1 drop every hour until the birth of the baby. When cervical dilatation was in the range of 8-10 cm, pain level was re-evaluated only with VAS. Spielberger Continuity Anxiety Scale was applied with face-to-face interview technique within 4-24 hours following the birth.
placebo saline solutions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
paın score
Time Frame: pre-intervention
Determination of pain score before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with visual pain score (0=no pain, 10=worst pain)
pre-intervention
paın score
Time Frame: Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
Determination of pain score before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with visual pain score (0=no pain, 10=worst pain)
Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
paın score
Time Frame: Between contractions in about 3-4 hours after the intervention in the 8-10 cm cervical dilatation range
Determination of pain score before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with visual pain score (0=no pain, 10=worst pain)
Between contractions in about 3-4 hours after the intervention in the 8-10 cm cervical dilatation range
anxiety level
Time Frame: pre-intervention
Determination of anxiety level before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with STAI From TX-I and TX-II (State-Trait Anxiety Tests) (The highest possible score is 80 and the lowest possible score is 20)
pre-intervention
anxiety level
Time Frame: Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
Determination of anxiety level before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with STAI From TX-I and TX-II (State-Trait Anxiety Tests) (The highest possible score is 80 and the lowest possible score is 20)
Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
anxiety level
Time Frame: postpartum 4-24 hours
Determination of anxiety level before and after essential oil (lemon oil and ylang ylang oil) and saline inhalation with STAI From TX-I and TX-II (State-Trait Anxiety Tests) (The highest possible score is 80 and the lowest possible score is 20)
postpartum 4-24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
apgar score
Time Frame: postnatal 5. minute
Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration." In the test, five things are used to check a baby's health. (0-10 point)
postnatal 5. minute
apgar score
Time Frame: postnatal 10. minute
Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration." In the test, five things are used to check a baby's health. (0-10 point)
postnatal 10. minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: ÖZLEM ÇAĞAN, ASSİST.PROF., Eskisehir Osmangazi University
  • Study Director: SEVGİ KOÇ, PROF. DR., ETLİK ZÜBEYDE HANIM GYN DISEASES TRAINING AND RESEARCH HOSPITAL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

November 11, 2022

First Submitted That Met QC Criteria

December 10, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 10, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cagan01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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