Pain, LaborAromatherapyNCT05657431

The Effect of Ylang Ylang Oil and Lemon Oil

A study testing essential oils (Ylang ylang oil) and essential oils (lemon oil) in people with Pain, Labor and Anxiety, run by Özlem Çağan at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pain, Labor, Anxiety, Aromatherapy
What is being tested?: essential oils (Ylang ylang oil) and essential oils (lemon oil)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jun 2019to 30 Nov 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Show all 12Show fewer

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Etlik Zübeyde Hanim Hospital
Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Ylang Ylang Oil and Lemon Oil Inhalation on Active Phase Labor Pain and Anxiety 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
Being tested: essential oils (Ylang ylang oil), placebo (saline solutions), essential oils (lemon oil)
Keywords: primiparous, labor pain, aromatherapy, lemon oil, ylang ylang oil
Medical subject headings: Labor Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05657431
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Other: placebo (saline solutions)

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: postpartum 4-24 hours

Secondary outcomes (2)

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)
Measured: postnatal 5. minute
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)
Measured: postnatal 10. minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201930 Nov 2021

First posted20 Dec 2022
Study start1 Jun 2019
Primary completion30 Nov 2021
Study completion30 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pain, LaborStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05657431
Sponsor's protocol ID: Cagan01
Acronym: Aromatherapy
Status last verified: Dec 2022
First submitted: 11 Nov 2022
Last updated: 20 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 25558267

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management

All Pain, Labor trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Ylang Ylang Oil and Lemon Oil Inhalation on Active Phase Labor Pain and Anxiety in Primiparous Pregnant Women
ClinicalTrials.gov ID: NCT05657431
Acronym / sponsor ID: Aromatherapy / Cagan01
Conditions: Pain, Labor, Anxiety, Aromatherapy
Keywords: primiparous, labor pain, aromatherapy, lemon oil, ylang ylang oil
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Özlem ÇağanUniversity, hospital or other
Study start: 1 Jun 2019 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 30 Nov 2021 (actual)
First posted: 20 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main questions it aims to answer are:

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
group 1 (Ylang ylang oil)	Experimental	Other: essential oils (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 2 (Lemon oil)	Experimental	Other: essential oils (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 3 (Control)	Placebo comparator	Other: placebo (saline solutions)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.

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
essential oils (Ylang ylang oil)inhaler aromatherapy	Other	group 1 (Ylang ylang oil)
placebo (saline solutions)placebo saline solutions	Other	group 3 (Control)
essential oils (lemon oil)inhaler aromatherapy	Other	group 2 (Lemon oil)

Primary outcome

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)
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)
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)
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)
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)
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)

2 secondary outcomes

apgar score
Time frame: postnatal 5. minute
apgar score
Time frame: postnatal 10. minute

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
Background: PubMed 25558267Kaviani 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.
Individual participant dataSharing planned: No

Related trials for Pain, Labor

Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ÖZLEM ÇAĞAN, ASSİST.PROF. study director

Eskişehir Osmangazi University

SEVGİ KOÇ, PROF. DR. study director

ETLİK ZÜBEYDE HANIM GYN DISEASES TRAINING AND RESEARCH HOSPITAL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing essential oils (Ylang ylang oil) and essential oils (lemon oil) in people with Pain, Labor and Anxiety, run by Özlem Çağan at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

paın score (time frame: pre-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05657431, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.