- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05130957
The Effect of Clove Oil on Labor Pain
March 5, 2023 updated by: Nükhet Kaçar, Ankara City Hospital Bilkent
The Effect of Massage Applied With Clove Oil on Perceived Labor Pain
The study has two groups.
one of them is experimental group that is given massage with clove oil.
The other one is control group that is given standard midwifery care.
Each group consists of 30 women.
We will evaluate their labor pain scores by using Visual Analogue Scale before and after massage application.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Labor is a painful process.
That's why there are lots of nonpharmacological methods to reduce labor pain.
Especially most clinical guide suggests giving massage to pregnant who has labor pain.
In the literature, there are a lot of study examining effectiveness of massage techniques.
However there is no study about massage application with clove oil on labor pain.
The investigators would like to give a massage with clove oil to pregnants to reduce their labor pain.
Hereby the investigators will evaluate effectiveness of clove oil.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey
- Ankara City Hospital- Maternity Hospital
-
-
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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- All of volunteer and pregnant women is 18-35 years old.
Exclusion Criteria:
- The pregnant women has any obstetrical complications.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
The pregnant women in the experimental group are given a massage with clove oil.
|
The experimental group is given a massage with clove oil,
|
|
Other: Control Group
The pregnant women in the control group are given a massage without any oil as standard midwifery care
|
The control group is given a massage without any oil as a standard midwifery care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: during labor process, until the labor process is done.
|
The scale has 0-10 points.
As the point increases the pain score increases
|
during labor process, until the labor process is done.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nükhet Kaçar, MSc., Ankara City Hospital- Maternity Hospital
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 (Actual)
November 1, 2021
Primary Completion (Actual)
February 1, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
November 12, 2021
First Submitted That Met QC Criteria
November 12, 2021
First Posted (Actual)
November 23, 2021
Study Record Updates
Last Update Posted (Estimate)
March 7, 2023
Last Update Submitted That Met QC Criteria
March 5, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AnkaraCHBilkent-MH-NK-01
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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