Effects of Rosa Damascena and Frankincense Essential Oils in Labor

December 31, 2023 updated by: Tuba Kızılkaya, Balikesir University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

During childbirth; pain, anxiety, and comfort level of women have a critical importance for a positive childbirth experience. So this study aims to compare the effects of different essential oils on labor pain, anxiety and labor comfort. In some studies, rosa damascena was found effective for labor pain. However, there are limited studies about comfort level and anxiety level of women during labor. So we aimed to investigate whether rosa damascena oil was effective for labor comfort and anxiety level or not. Samely it will be investigated frankincense oil was effective for labor comfort and anxiety level or not. Also which essential oil was more effective during labor will be analyzed.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Pregnant women who are at latent phase of labor

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosa damascena oil group
Other: Essential oils
Essential oils will used by inhalation
Other Names:
  • %0.9 NaCl solution
Experimental: Frankincense oil group
Other: Essential oils
Essential oils will used by inhalation
Other Names:
  • %0.9 NaCl solution
Active Comparator: Solution group
Other: Essential oils
Essential oils will used by inhalation
Other Names:
  • %0.9 NaCl solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
labor pain
Time Frame: 3 hours
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
Time Frame: 3 hours
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
Time Frame: 3 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balikesir University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 21, 2024

Primary Completion (Estimated)

November 20, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 16, 2023

First Submitted That Met QC Criteria

December 31, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 31, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20062023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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