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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05657431
Other study ID # Cagan01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date November 30, 2021

Study information

Verified date December 2022
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
essential oils (Ylang ylang oil)
inhaler aromatherapy
placebo (saline solutions)
placebo saline solutions
essential oils (lemon oil)
inhaler aromatherapy

Locations

Country Name City State
Turkey Etlik Zübeyde Hanim Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Özlem Çagan

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pain 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) pre-intervention
Primary pain 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) Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
Primary pain 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) Between contractions in about 3-4 hours after the intervention in the 8-10 cm cervical dilatation range
Primary 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) pre-intervention
Primary 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) Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm
Primary 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) postpartum 4-24 hours
Secondary 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) postnatal 5. minute
Secondary 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) postnatal 10. minute
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