The Effect of Clove Oil on Labor Pain

• Sponsor: Ankara City Hospital Bilkent (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05130957
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Other: Massage Application with clove oil; Other: Massage Application without any oil	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: There are two groups as experimental and control.There are two groups as experimental and control.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Massage Applied With Clove Oil on Perceived Labor Pain
• Actual Study Start Date: Nov 1, 2021
• Actual Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group The pregnant women in the experimental group are given a massage with clove oil.	Other: Massage Application with clove oil; The experimental group is given a massage with clove oil,
Other: Control Group The pregnant women in the control group are given a massage without any oil as standard midwifery care	Other: Massage Application without any oil; The control group is given a massage without any oil as a standard midwifery care.

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale [during labor process, until the labor process is done.]

   The scale has 0-10 points. As the point increases the pain score increases

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• The pregnant women has any obstetrical complications.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara City Hospital- Maternity Hospital	Ankara	Çankaya	Turkey

Sponsors and Collaborators

• Ankara City Hospital Bilkent

Investigators

• Principal Investigator: Nükhet Kaçar, MSc., Ankara City Hospital- Maternity Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nükhet Kaçar, Principal Investigator, Ankara City Hospital Bilkent
• ClinicalTrials.gov Identifier: NCT05130957
• Other Study ID Numbers: AnkaraCHBilkent-MH-NK-01
• First Posted: Nov 23, 2021
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nükhet Kaçar, Principal Investigator, Ankara City Hospital Bilkent: labor pain; midwifery; pregnant women; massage
• Additional relevant MeSH terms: Labor Pain

Study Results

No Results Posted as of Jul 27, 2022