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The Effect Of Lavender Essential Oil On Birth Pain

Primary Purpose

Labor Pain, Aromatherapy

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Aromatherapy application /massage with lavender oil
Aromatherapy application / inhalation with lavender oil
Sponsored by
Near East University, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring Labor Pain, Aromatherapy,, Lavender Essential Oil, Aromatherapy with lavender essential oil

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

INCLUSİON CRİTERİA:

  • Single pregnancy
  • Primiparous gestational age more than 36 weeks (term)
  • Cervical dilatation of at least 3 cm
  • Pregnants with 3 uterine contractions in a 10-minute period lasting at least 30 seconds
  • Cephalic presentation
  • Not receiving analgesics, sedatives or anesthetics during labor,
  • Not using induction at birth

EXCLUSİON CRİTERİA:

  • Multiparity
  • cephalopelvic incompatibility
  • third trimester bleeding history
  • intrauterine growth retardation
  • multiple pregnancy
  • breech presentation
  • subject's withdrawal from clinical trial
  • allergy to aromatic lavender essential oil
  • addiction (alcohol, smoking)
  • obstetric conditions requiring emergency cesarean section
  • infertility history
  • previous history of diagnosis of an underlying disease
  • induction at birth

Sites / Locations

  • Near East University / Turkish Republic of Northern Cyprus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Placebo Comparator

No Intervention

Arm Label

massage group with lavender essential oil

group of inhalations with lavender essential oil

control group

Arm Description

Pregnant women (n:37) who participated in this group were given an intense massage for at least 10 minutes in each phase during the first phase of labor. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied before and after the application, and the process was completed with a total of 6 measurements.

Pregnant women (n:44) who participated in this group were administered inhalation with lavender oil at an intensity of at least 10 minutes in each phase during the first phase of labor. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied before and after the application, and the process was completed with a total of 6 measurements.

No application was made to the pregnant women (n:40) who participated in this group in each phase of the first phase of labor. Despite this, the Visual Analog Pain Scale and McGill Melzack Pain Questionnaire, which were applied at the beginning of each phase in order to increase the reliability of the results, were re-evaluated 30 minutes after the measurements, even though there was no application, and the process was completed with a total of 6 measurements.

Outcomes

Primary Outcome Measures

Visual Analog Scale
It is used to convert some values that cannot be measured numerically into numeric. Two extreme values of the parameter to be evaluated are written at the two ends of a 10 cm line, and the patient is asked to determine where his/her condition is appropriate on this line by drawing a line, putting a dot or placing any sign. For pain; "I have no pain" is written on one end and "very severe pain" is written on the other end and the patient is asked to mark the current situation on the line. The minimum score from the scale is 0, and the maximum score is 10. According to the scale, the highest pain value is expressed with 10 points, while 0 defines the least pain.
McGill Melzack Pain Questionnaire
It is a multidimensional pain assessment tool consisting of four parts. At the entrance of the form, personal information of the patient, medical diagnosis-problem, introductory information to determine the location, characteristics, relationship and severity of pain according to the patient's perception are included. In the McGill Melzack pain questionnaire, the lowest score is 0 and the highest score is 112. 0 denotes the least pain level and the least pain-related discomfort, while 112 denotes the most severe pain and the most pain-related discomfort.
Questionnaire
It was developed by the researcher as a result of literature review and includes 30 questions in total. It was aimed to collect information about the sociodemographic and obstetric anamnesis of pregnant women through the form.
Postpartum Period Data Collection Form
It was developed by the researcher as a result of literature review and includes 21 questions in total. Via the form; It is aimed to collect information on labor, newborn characteristics, postpartum mother and baby interaction, and evaluation of mothers' satisfaction with massage or inhalation methods.

Secondary Outcome Measures

Full Information

First Posted
November 26, 2021
Last Updated
December 22, 2021
Sponsor
Near East University, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05169138
Brief Title
The Effect Of Lavender Essential Oil On Birth Pain
Official Title
The Effect Of Lavender Essential Oil And Inhalation And Massage Methods On Birth Pain İn Primiparous Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Near East University, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study was planned as a randomized controlled trial to determine the effect of lavender oil applied to primiparous women by inhalation and massage methods on labor pain.
Detailed Description
In universe of the research; Pregnant women who applied to Adana Seyhan State Hospital's Marsa Gynecology and Obstetrics Additional Service Building and Obstetrics Service and Delivery Room between the dates of the study, accepted to participate in the study voluntarily and who met the research conditions included. Numbers 1-2 of a 6-sided dice determined by the dice rolling system formed the control group (40 pregnant), numbers 3-4 were lavender oil inhalation group (44 pregnant), and numbers 5-6 were lavender oil massage group (37 pregnant). The research was carried out in three stages for the experimental groups and control groups. First stage; Informed Voluntary Consent Form and Questionnaire were applied to the pregnant women whose groups were determined by the chosen randomization method. Afterwards, for the experimental groups according to the group; 10-minute training sessions were given on the inhalation method or massage method with aromatic lavender essential oil. In the second stage; Data were recorded by dividing the first phase of labor into 3 phases for each group. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied to the experimental groups 6 times, before and 30 minutes after the application. At this stage, no application was made in the control group, the Visual Analog Pain Scales and McGill Melzack Pain Questionnaire were applied at the beginning of each phase, the same forms were repeated after 30 minutes and the data were recorded 6 times in total. In the third stage; In the postpartum period, the study was completed by applying the Postpartum Period Information Collection Form by face-to-face interviews with the experimental groups and the pregnant women in the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Aromatherapy
Keywords
Labor Pain, Aromatherapy,, Lavender Essential Oil, Aromatherapy with lavender essential oil

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The research was planned to define the superiority of inhalation and massage methods applied with lavender oil compared to the control group and each other.
Masking
Care Provider
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
massage group with lavender essential oil
Arm Type
Placebo Comparator
Arm Description
Pregnant women (n:37) who participated in this group were given an intense massage for at least 10 minutes in each phase during the first phase of labor. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied before and after the application, and the process was completed with a total of 6 measurements.
Arm Title
group of inhalations with lavender essential oil
Arm Type
Placebo Comparator
Arm Description
Pregnant women (n:44) who participated in this group were administered inhalation with lavender oil at an intensity of at least 10 minutes in each phase during the first phase of labor. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied before and after the application, and the process was completed with a total of 6 measurements.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No application was made to the pregnant women (n:40) who participated in this group in each phase of the first phase of labor. Despite this, the Visual Analog Pain Scale and McGill Melzack Pain Questionnaire, which were applied at the beginning of each phase in order to increase the reliability of the results, were re-evaluated 30 minutes after the measurements, even though there was no application, and the process was completed with a total of 6 measurements.
Intervention Type
Other
Intervention Name(s)
Aromatherapy application /massage with lavender oil
Intervention Description
The application was applied to 37 pregnant women in total, and the effect of massage with lavender oil on labor pain was investigated.
Intervention Type
Other
Intervention Name(s)
Aromatherapy application / inhalation with lavender oil
Intervention Description
The application was applied to 41 pregnant women in total, and the effect of inhalation with lavender oil on labor pain was investigated.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
It is used to convert some values that cannot be measured numerically into numeric. Two extreme values of the parameter to be evaluated are written at the two ends of a 10 cm line, and the patient is asked to determine where his/her condition is appropriate on this line by drawing a line, putting a dot or placing any sign. For pain; "I have no pain" is written on one end and "very severe pain" is written on the other end and the patient is asked to mark the current situation on the line. The minimum score from the scale is 0, and the maximum score is 10. According to the scale, the highest pain value is expressed with 10 points, while 0 defines the least pain.
Time Frame
through study completion, an average of 9 month
Title
McGill Melzack Pain Questionnaire
Description
It is a multidimensional pain assessment tool consisting of four parts. At the entrance of the form, personal information of the patient, medical diagnosis-problem, introductory information to determine the location, characteristics, relationship and severity of pain according to the patient's perception are included. In the McGill Melzack pain questionnaire, the lowest score is 0 and the highest score is 112. 0 denotes the least pain level and the least pain-related discomfort, while 112 denotes the most severe pain and the most pain-related discomfort.
Time Frame
through study completion, an average of 9 month
Title
Questionnaire
Description
It was developed by the researcher as a result of literature review and includes 30 questions in total. It was aimed to collect information about the sociodemographic and obstetric anamnesis of pregnant women through the form.
Time Frame
through study completion, an average of 9 month
Title
Postpartum Period Data Collection Form
Description
It was developed by the researcher as a result of literature review and includes 21 questions in total. Via the form; It is aimed to collect information on labor, newborn characteristics, postpartum mother and baby interaction, and evaluation of mothers' satisfaction with massage or inhalation methods.
Time Frame
through study completion, an average of 9 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only primiparous women can participate in this study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSİON CRİTERİA: Single pregnancy Primiparous gestational age more than 36 weeks (term) Cervical dilatation of at least 3 cm Pregnants with 3 uterine contractions in a 10-minute period lasting at least 30 seconds Cephalic presentation Not receiving analgesics, sedatives or anesthetics during labor, Not using induction at birth EXCLUSİON CRİTERİA: Multiparity cephalopelvic incompatibility third trimester bleeding history intrauterine growth retardation multiple pregnancy breech presentation subject's withdrawal from clinical trial allergy to aromatic lavender essential oil addiction (alcohol, smoking) obstetric conditions requiring emergency cesarean section infertility history previous history of diagnosis of an underlying disease induction at birth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filiz Yarıcı
Organizational Affiliation
Study Director
Official's Role
Study Director
Facility Information:
Facility Name
Near East University / Turkish Republic of Northern Cyprus
City
Nicosia
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect Of Lavender Essential Oil On Birth Pain

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