NCT05130957

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.

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

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

November 1, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

November 12, 2021

Last Update Submit

March 5, 2023

Conditions

Labor Pain

Keywords

labor painmidwiferypregnant womenmassage

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 (2)

Experimental Group

EXPERIMENTAL

The pregnant women in the experimental group are given a massage with clove oil.

Other: Massage Application with clove oil

Control Group

OTHER

The pregnant women in the control group are given a massage without any oil as standard midwifery care

Other: Massage Application without any oil

Interventions

Massage Application with clove oilOTHER

The experimental group is given a massage with clove oil,

Experimental Group
Massage Application without any oilOTHER

The control group is given a massage without any oil as a standard midwifery care.

Control Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBecause we study with pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All of volunteer and pregnant women is 18-35 years old.

You may not qualify if:

  • The pregnant women has any obstetrical complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital- Maternity Hospital

Ankara, Çankaya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Clove Oil

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Nükhet Kaçar, MSc.

    Ankara City Hospital- Maternity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are two groups as experimental and control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2021

First Posted

November 23, 2021

Study Start

November 1, 2021

Primary Completion

February 1, 2022

Study Completion

September 1, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)