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

Primary Purpose

Pain, Labor, Anxiety, Aromatherapy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
essential oils (Ylang ylang oil)
placebo (saline solutions)
essential oils (lemon oil)
Sponsored by
Özlem Çağan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Labor focused on measuring primiparous, labor pain, aromatherapy, lemon oil, ylang ylang oil

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Etlik Zübeyde Hanim Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

group 1 (Ylang ylang oil)

group 2 (Lemon oil)

group 3 (Control)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

paın score
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)
paın score
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)
paın score
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)
anxiety level
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)
anxiety level
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)
anxiety level
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)

Secondary Outcome Measures

apgar score
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)
apgar score
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)

Full Information

First Posted
November 11, 2022
Last Updated
December 10, 2022
Sponsor
Özlem Çağan
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1. Study Identification

Unique Protocol Identification Number
NCT05657431
Brief Title
The Effect of Ylang Ylang Oil and Lemon Oil
Acronym
Aromatherapy
Official Title
The Effect of Ylang Ylang Oil and Lemon Oil Inhalation on Active Phase Labor Pain and Anxiety in Primiparous Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Özlem Çağan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Labor, Anxiety, Aromatherapy
Keywords
primiparous, labor pain, aromatherapy, lemon oil, ylang ylang oil

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1 (Ylang ylang oil)
Arm Type
Experimental
Arm Description
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.
Arm Title
group 2 (Lemon oil)
Arm Type
Experimental
Arm Description
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.
Arm Title
group 3 (Control)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
essential oils (Ylang ylang oil)
Intervention Description
inhaler aromatherapy
Intervention Type
Other
Intervention Name(s)
placebo (saline solutions)
Intervention Description
placebo saline solutions
Intervention Type
Other
Intervention Name(s)
essential oils (lemon oil)
Intervention Description
inhaler aromatherapy
Primary Outcome Measure Information:
Title
paın score
Description
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)
Time Frame
pre-intervention
Title
paın score
Description
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)
Time Frame
Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
Title
paın score
Description
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)
Time Frame
Between contractions in about 3-4 hours after the intervention in the 8-10 cm cervical dilatation range
Title
anxiety level
Description
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)
Time Frame
pre-intervention
Title
anxiety level
Description
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)
Time Frame
Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
Title
anxiety level
Description
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)
Time Frame
postpartum 4-24 hours
Secondary Outcome Measure Information:
Title
apgar score
Description
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)
Time Frame
postnatal 5. minute
Title
apgar score
Description
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)
Time Frame
postnatal 10. minute

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
prengnancy woman
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ÖZLEM ÇAĞAN, ASSİST.PROF.
Organizational Affiliation
Eskişehir Osmangazi University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
SEVGİ KOÇ, PROF. DR.
Organizational Affiliation
ETLİK ZÜBEYDE HANIM GYN DISEASES TRAINING AND RESEARCH HOSPITAL
Official's Role
Study Director
Facility Information:
Facility Name
Etlik Zübeyde Hanim Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25558267
Citation
Kaviani M, Maghbool S, Azima S, Tabaei MH. Comparison of the effect of aromatherapy with Jasminum officinale and Salvia officinale on pain severity and labor outcome in nulliparous women. Iran J Nurs Midwifery Res. 2014 Nov;19(6):666-72.
Results Reference
background

Learn more about this trial

The Effect of Ylang Ylang Oil and Lemon Oil

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