Clinical trial NCT05657431: The Effect of Ylang Ylang Oil and Lemon Oil
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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Labor
Anxiety
Aromatherapy
Keywords: primiparous
labor pain
aromatherapy
lemon oil
ylang ylang oil
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: paın score
timeFrame: pre-intervention
measure: paın score
timeFrame: Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
measure: paın score
timeFrame: Between contractions in about 3-4 hours after the intervention in the 8-10 cm cervical dilatation range
measure: anxiety level
timeFrame: pre-intervention
measure: anxiety level
timeFrame: Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
measure: anxiety level
timeFrame: postpartum 4-24 hours
Secondary outcomes:
measure: apgar score
timeFrame: postnatal 5. minute
measure: apgar score
timeFrame: postnatal 10. minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik Zübeyde Hanim Hospital
Study officials:
affiliation: Eskişehir Osmangazi University
name: ÖZLEM ÇAĞAN, ASSİST.PROF.
role: STUDY_DIRECTOR
affiliation: ETLİK ZÜBEYDE HANIM GYN DISEASES TRAINING AND RESEARCH HOSPITAL
name: SEVGİ KOÇ, PROF. DR.
role: STUDY_DIRECTOR
References:
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.