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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06189794
Other study ID # 20062023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 21, 2024
Est. completion date December 31, 2024

Study information

Verified date December 2023
Source Balikesir University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 39
Est. completion date December 31, 2024
Est. primary completion date November 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Essential oils
Essential oils will used by inhalation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Balikesir University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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