NCT05136066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

November 13, 2021

Last Update Submit

July 25, 2023

Conditions

Keywords

labor painmint oilVisuel anolgue Scoring

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Group massaged with peppermint oil

EXPERIMENTAL

Group of experimental

Other: massage with peppermint oil

Interventions

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

Group massaged with peppermint oil

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Massagepeppermint oil

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Rahime Bedir Findik, Dr

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Two groups with mint oil control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr

Study Record Dates

First Submitted

November 13, 2021

First Posted

November 26, 2021

Study Start

November 13, 2021

Primary Completion

January 20, 2023

Study Completion

May 15, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations