NCT06189794

Brief Summary

This randomized controlled study aims to compare effects of different essential oils in labor pain, anxiety and childbirth comfort. The main questions it aims to answer are: Is it effective using rosa damascena oil during labor? Is it effective using frankincense oil during labor? Which essential oil is more effective during labor Researchers will compare aromatherapy oils groups to see labor pain, anxiety and childbirth comfort levels of pregnant women.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

January 21, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 18, 2025

Status Verified

July 1, 2024

Enrollment Period

1.9 years

First QC Date

December 16, 2023

Last Update Submit

June 14, 2025

Conditions

Labor Pain

Keywords

AromatherapyChildbirth ProblemsRosa damascenaFrankincenseComfort

Outcome Measures

Primary Outcomes (3)

  • labor pain

    Numerical Rating Score. requires the patient to rate their pain on a defined scale. 0-10 where 0 is no pain and 10 is the worst pain imaginable.

    3 hours

  • childbirth comfort

    Childbirth Comfort Questionnaire. It has 14 items to assess the comfort of the women during childbirth. The minimum score that can be obtained from the scale is 14 and the highest score is 70. Items 2,4,6,9,12,13,14 need to be reversed. As the score increases, high level comfort is indicated, and as it decreases, low level comfort is indicated.

    3 hours

  • anxiety

    Spielberger Anxiety Questionnaire. This questionnaire is a commonly used measure of trait and state anxiety. has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

    3 hours

Study Arms (3)

Rosa damascena oil group

EXPERIMENTAL

Rosa Damascene oil will be used

Other: Rosa damascena oil

Frankincense oil group

ACTIVE COMPARATOR

Frankincense oil will be used

Other: Rosa damascena oil

Solution group

PLACEBO COMPARATOR

%0.9 NaCl Isotonical Solution will be used

Other: Rosa damascena oil

Interventions

Rosa damascena oilOTHER

Essential oils will used by inhalation

Also known as: Frankincense oil, Solution group
Frankincense oil groupRosa damascena oil groupSolution group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Pregnant women who are at latent phase of labor

You may not qualify if:

  • Complicated pregnancy (preeclampsia, hypertension, diabetes etc.)
  • Women who will have planned cesarean section
  • Asthma or any other respiratory disease
  • Allergies to Rosa Damascena or Frankincense oil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University Hospital

Balıkesir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

Frankincense

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • Tuba Kızılkaya, Asst.Prof.

    Balikesir University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuba Kızılkaya, Asst.Prof.

CONTACT

+905514051804kizilkaya.tb@gmail.com

Esra Cevik, Asst.Prof.

CONTACT

+905433895090esracevik@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Pregnant women won't be introduced which essential oil would be used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. PhD

Study Record Dates

First Submitted

December 16, 2023

First Posted

January 5, 2024

Study Start

January 21, 2024

Primary Completion

December 21, 2025

Study Completion

December 31, 2025

Last Updated

June 18, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)