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Completed

NCT Number: NCT05169138

The Effect Of Lavender Essential Oil On Birth Pain

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.

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Key information

Conditions

Labor Pain Aromatherapy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Near East University / Turkish Republic of Northern Cyprus

Nicosia, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Visual Analog Scale

    Time frame: through study completion, an average of 9 month

    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.

  2. McGill Melzack Pain Questionnaire

    Time frame: through study completion, an average of 9 month

    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.

  3. Questionnaire

    Time frame: through study completion, an average of 9 month

    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.

  4. Postpartum Period Data Collection Form

    Time frame: through study completion, an average of 9 month

    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.

Sponsors and collaborators

Lead sponsor

Near East University, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2021
Registry last updated
Dec 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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