跳至主要内容
临床试验/NCT05169138
NCT05169138已完成不适用

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

Near East University, Turkey1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
121
试验地点
1
主要终点
Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Questionnaire

时间窗: 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.

Postpartum Period Data Collection Form

时间窗: 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.

McGill Melzack Pain Questionnaire

时间窗: 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.

Visual Analog Scale

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Near East University, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seda Karatopuk

Assistant Lecturer

Near East University, Turkey

研究点 (1)

Loading locations...

相似试验

The Effect Of Lavender Essential Oil On Birth Pain | 临床试验