- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05657431
The Effect of Ylang Ylang Oil and Lemon Oil (Aromatherapy)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey
- Etlik Zübeyde Hanim Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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placebo saline solutions
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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)
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pre-intervention
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paın score
Time Frame: Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
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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)
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Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
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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)
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Between contractions in about 3-4 hours after the intervention in the 8-10 cm cervical dilatation range
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anxiety level
Time Frame: pre-intervention
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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)
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pre-intervention
|
anxiety level
Time Frame: Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
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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)
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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)
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postpartum 4-24 hours
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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)
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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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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