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NCT Number: NCT05657431

The Effect of Ylang Ylang Oil and Lemon Oil

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.

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Key information

Conditions

Pain, Labor Anxiety Anxiety Disorders Aromatherapy Labor Pain Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Etlik Zübeyde Hanim Hospital

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

essential oils (Ylang ylang oil)

Other

inhaler aromatherapy

placebo (saline solutions)

Other

placebo saline solutions

essential oils (lemon oil)

Other

inhaler aromatherapy

Primary outcomes

  1. 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)

  2. paın score

    Time frame: Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm

    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)

  3. 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)

  4. anxiety level

    Time frame: pre-intervention

    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)

  5. anxiety level

    Time frame: Between contractions within 1 hour after the intervention in the cervical dilatation range of 5-7 cm

    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)

  6. 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)

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Özlem Çağan

Other

Registry information

Official study title

The Effect of Ylang Ylang Oil and Lemon Oil Inhalation on Active Phase Labor Pain and Anxiety in Primiparous Pregnant Women

Acronym: Aromatherapy

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2022
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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