The Effect of Ylang Ylang Oil and Lemon Oil

NCT ID: NCT05657431

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Labor Anxiety Aromatherapy

Keywords

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primiparous labor pain aromatherapy lemon oil ylang ylang oil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

essential oils (Ylang ylang oil)

Intervention Type OTHER

inhaler aromatherapy

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.

Group Type EXPERIMENTAL

essential oils (lemon oil)

Intervention Type OTHER

inhaler aromatherapy

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.

Group Type PLACEBO_COMPARATOR

placebo (saline solutions)

Intervention Type OTHER

placebo saline solutions

Interventions

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essential oils (Ylang ylang oil)

inhaler aromatherapy

Intervention Type OTHER

placebo (saline solutions)

placebo saline solutions

Intervention Type OTHER

essential oils (lemon oil)

inhaler aromatherapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Özlem Çağan

OTHER

Sponsor Role lead

Responsible Party

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Özlem Çağan

assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ÖZLEM ÇAĞAN, ASSİST.PROF.

Role: STUDY_DIRECTOR

Eskişehir Osmangazi University

SEVGİ KOÇ, PROF. DR.

Role: STUDY_DIRECTOR

ETLİK ZÜBEYDE HANIM GYN DISEASES TRAINING AND RESEARCH HOSPITAL

Locations

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Etlik Zübeyde Hanim Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25558267 (View on PubMed)

Other Identifiers

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Cagan01

Identifier Type: -

Identifier Source: org_study_id