Back to resultsThe Effect of Clove Oil on Labor Pain
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Massage Application with clove oil
Massage Application without any oil
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring labor pain, midwifery, pregnant women, massage
Eligibility Criteria
Inclusion Criteria:
- All of volunteer and pregnant women is 18-35 years old.
Exclusion Criteria:
- The pregnant women has any obstetrical complications.
Sites / Locations
- Ankara City Hospital- Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental Group
Control Group
Arm Description
The pregnant women in the experimental group are given a massage with clove oil.
The pregnant women in the control group are given a massage without any oil as standard midwifery care
Outcomes
Primary Outcome Measures
Visual Analogue Scale
The scale has 0-10 points. As the point increases the pain score increases
Secondary Outcome Measures
Full Information
NCT ID
NCT05130957
First Posted
November 12, 2021
Last Updated
March 5, 2023
Sponsor
Ankara City Hospital Bilkent
1. Study Identification
Unique Protocol Identification Number
NCT05130957
Brief Title
The Effect of Clove Oil on Labor Pain
Official Title
The Effect of Massage Applied With Clove Oil on Perceived Labor Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
labor pain, midwifery, pregnant women, massage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two groups as experimental and control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The pregnant women in the experimental group are given a massage with clove oil.
Arm Title
Control Group
Arm Type
Other
Arm Description
The pregnant women in the control group are given a massage without any oil as standard midwifery care
Intervention Type
Other
Intervention Name(s)
Massage Application with clove oil
Intervention Description
The experimental group is given a massage with clove oil,
Intervention Type
Other
Intervention Name(s)
Massage Application without any oil
Intervention Description
The control group is given a massage without any oil as a standard midwifery care.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
The scale has 0-10 points. As the point increases the pain score increases
Time Frame
during labor process, until the labor process is done.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Because we study with pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All of volunteer and pregnant women is 18-35 years old.
Exclusion Criteria:
The pregnant women has any obstetrical complications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nükhet Kaçar, MSc.
Organizational Affiliation
Ankara City Hospital- Maternity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara City Hospital- Maternity Hospital
City
Ankara
State/Province
Çankaya
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Clove Oil on Labor Pain
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