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Effects of Massage With Peppermint Oil on Labor Pain

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
massage with peppermint oil
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring labor pain, mint oil, Visuel anolgue Scoring

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • normal pregnant with vertex presentation
  • at least 70% 5-6 cm gap in the examination at least 4-5 severe contractions in 10 minutes
  • Turkish-speaking

Exclusion Criteria:

  • Pregnant women with co-morbidities, chronic diseases
  • complications related to childbirth
  • inactive labor
  • anemic, thyroid disease, skin lesions or infection, allergies, multiple pregnancies
  • use of any medication
  • risky pregnancy

Sites / Locations

  • Ankara City Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group massaged with peppermint oil

Arm Description

Group of experimental

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

First Posted
November 13, 2021
Last Updated
July 25, 2023
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT05136066
Brief Title
Effects of Massage With Peppermint Oil on Labor Pain
Official Title
Effects of Massage With Diluted Peppermint Oil on Visual Analogue Scoring in Reducing Labor Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 13, 2021 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
May 15, 2023 (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
Birth is a very special experience for a woman and her family. Labor pain is one of the strongest known and defined pains today. In the literature, it has been stated that labor pain is perceived as more severe than chronic pain such as low back pain, cancer pain, phantom pain and postherpetic neuralgia, and acute pain such as fracture or laceration. When birth pain is not controlled, the vicious cycle of stress, fear and pain can continue and affect the mother and fetus negatively. In this study, our aim is to determine the effect of applying peppermint oil diluted with pure natural olive oil to the abdomen and waist region by massage in labor pain, reducing the labor pain.
Detailed Description
The study is a Prospective Cross-sectional Case Control study. Pregnant women whose mother tongue is Turkish, who are term pregnant and who are in active labor, who are hospitalized in the delivery room of our hospital for delivery, that is, who have a gap of at least 70% 5-6 cm in the examination and who have at least 4-5 severe contractions in 10 minutes, who have a single, vertex-presented fetus will be included in our work. Pregnant women with co-morbidities, chronic diseases, complications related to childbirth, anemic inactive labor, thyroid disease, skin lesions or infections, allergies, multiple pregnancies, use of any medication, and risky pregnancy will be excluded from the study. For this, 30 pregnant women who were applied peppermint oil and 30 control group pregnant women who were not applied will be included in the study. Following the signed consent form obtained from our patients, visual analog scoring (VAS) will be provided to the patient during the painful period, and then peppermint oil will be applied to the abdomen and lumbar region where he feels the most pain, with 1/10 diluted peppermint oil by hand massage or with the help of a compress moistened with warm water. After the application, visual pain scoring will be applied to pregnant women again.The study is terminated when sufficient data is obtained. The data will be entered into the computer in the SPSS program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
labor pain, mint oil, Visuel anolgue Scoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Two groups with mint oil control group
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group massaged with peppermint oil
Arm Type
Experimental
Arm Description
Group of experimental
Intervention Type
Other
Intervention Name(s)
massage with peppermint oil
Intervention Description
Peppermint oil diluted with 1/10 pure olive oil will be applied to the pregnant to reduce labor pain.
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
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: normal pregnant with vertex presentation at least 70% 5-6 cm gap in the examination at least 4-5 severe contractions in 10 minutes Turkish-speaking Exclusion Criteria: Pregnant women with co-morbidities, chronic diseases complications related to childbirth inactive labor anemic, thyroid disease, skin lesions or infection, allergies, multiple pregnancies use of any medication risky pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahime Bedir Findik, Dr
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Massage With Peppermint Oil on Labor Pain

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