Clinical trial NCT05169138: 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
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Aromatherapy
Keywords: Labor Pain
Aromatherapy,
Lavender Essential Oil
Aromatherapy with lavender essential oil
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: through study completion, an average of 9 month
measure: McGill Melzack Pain Questionnaire
timeFrame: through study completion, an average of 9 month
measure: Questionnaire
timeFrame: through study completion, an average of 9 month
measure: Postpartum Period Data Collection Form
timeFrame: through study completion, an average of 9 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Near East University / Turkish Republic of Northern Cyprus
Study officials:
affiliation: Study Director
name: Filiz Yarıcı
role: STUDY_DIRECTOR
References: