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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05136066
Other study ID # AnkaraCHBilkent-MH-RBF-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 13, 2021
Est. completion date May 15, 2023

Study information

Verified date July 2023
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 15, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
massage with peppermint oil
Peppermint oil diluted with 1/10 pure olive oil will be applied to the pregnant to reduce labor pain.

Locations

Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale The scale has 0-10 points.As the point increases the pain score increases during labor process, until the labor process is done
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