The Effect of Ylang Ylang Oil and Lemon Oil

NCT05657431 | Completed

• 1 other identifier: Cagan01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Labor; Anxiety; Aromatherapy

Keywords

primiparous; labor pain; aromatherapy; lemon oil; ylang ylang oil

Outcome Measures

Primary Outcomes (6)

• paın 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

• paın 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

• paın 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

• 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

• 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

• 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 Outcomes (2)

• apgar score

  postnatal 5. minute

• apgar score

  postnatal 10. minute

Study Arms (3)

group 1 (Ylang ylang oil)

EXPERIMENTAL

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.

Other: essential oils (Ylang ylang oil)

group 2 (Lemon oil)

EXPERIMENTAL

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.

Other: essential oils (lemon oil)

group 3 (Control)

PLACEBO COMPARATOR

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.

Other: placebo (saline solutions)

Interventions

essential oils (Ylang ylang oil) OTHER

inhaler aromatherapy

group 1 (Ylang ylang oil)

placebo (saline solutions) OTHER

placebo saline solutions

group 3 (Control)

essential oils (lemon oil) OTHER

inhaler aromatherapy

group 2 (Lemon oil)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: prengnancy woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Özlem Çağan: lead

Study Sites (1)

Etlik Zübeyde Hanim Hospital

Ankara, Turkey (Türkiye)

Location

Related 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.

  PMID: 25558267 BACKGROUND

MeSH Terms

Conditions

Labor Pain; Anxiety Disorders

Interventions

Oils, Volatile; Sodium Chloride; lemon oil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• ÖZLEM ÇAĞAN, ASSİST.PROF.

  Eskişehir Osmangazi University

  STUDY DIRECTOR

• SEVGİ KOÇ, PROF. DR.

  ETLİK ZÜBEYDE HANIM GYN DISEASES TRAINING AND RESEARCH HOSPITAL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: December 20, 2022
• Study Start: June 1, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)