The Effect Of Lavender Essential Oil On Birth Pain

NCT05169138 | Completed DMC

• 1 other identifier: 2021/1367
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain; Aromatherapy

Keywords

Labor Pain; Aromatherapy,; Lavender Essential Oil; Aromatherapy with lavender essential oil

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

massage group with lavender essential oil

PLACEBO COMPARATOR

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.

Other: Aromatherapy application /massage with lavender oil

group of inhalations with lavender essential oil

PLACEBO COMPARATOR

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.

Other: Aromatherapy application / inhalation with lavender oil

control group

NO INTERVENTION

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.

Interventions

Aromatherapy application /massage with lavender oil OTHER

The application was applied to 37 pregnant women in total, and the effect of massage with lavender oil on labor pain was investigated.

massage group with lavender essential oil

Aromatherapy application / inhalation with lavender oil OTHER

The application was applied to 41 pregnant women in total, and the effect of inhalation with lavender oil on labor pain was investigated.

group of inhalations with lavender essential oil

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Only primiparous women can participate in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Near East University / Turkish Republic of Northern Cyprus

Nicosia, Cyprus

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Massage; lavender oil; Inhalation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Filiz Yarıcı

  Study Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 23, 2021
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)