The Effect Of Lavender Essential Oil On Birth Pain

Labor Pain Clinical Trial

Official title:

The Effect Of Lavender Essential Oil And Inhalation And Massage Methods On Birth Pain İn Primiparous Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05169138
• Other study ID #: 2021/1367
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: December 2021
• Source: Near East University, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

INCLUSION CRITERIA:

• 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

EXCLUSION CRITERIA:

• 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

Related Conditions & MeSH terms

• Aromatherapy
• Labor Pain

Intervention

Other:
• Aromatherapy application /massage with lavender oil
The application was applied to 37 pregnant women in total, and the effect of massage with lavender oil on labor pain was investigated.
• Aromatherapy application / inhalation with lavender oil
The application was applied to 41 pregnant women in total, and the effect of inhalation with lavender oil on labor pain was investigated.

Locations

Country	Name	City	State
Cyprus	Near East University / Turkish Republic of Northern Cyprus	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
Near East University, Turkey

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 9 month
Primary	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.	through study completion, an average of 9 month
Primary	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.	through study completion, an average of 9 month
Primary	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.	through study completion, an average of 9 month