Effect of aromatherapy with lavender on the pain intensity during the active phase of physiological labor in primiparous women referred to Arash Hospital.
The aim of this study is to investigate the effect of aromatherapy with lavender on the intensity of pain and anxiety during the active phase of physiological labor in primiparous women referred to Arash Hospital.
Design
A controlled, parallel, double-blind, randomized, phase 3 clinical trial on 110 patients who were divided into 2 groups using blocks of 4.
Settings and conduct
This study will be conducted in Arash Women Hospital, Tehran, Iran. After dividing natural vaginal delivery candidate patients into intervention and control groups using a random block list, the patients will receive the intervention of napkins soaked in lavender scent or a placebo of napkins soaked in water. Only the external observer of the study will be aware of the allocation of subjects.
Participants/Inclusion and exclusion criteria
All pregnant women with the age of 18-45 years, who went to Arash Women Hospital with a full-term singleton fetus for natural delivery and do not have any medical problems or pregnancy complications, mental illnesses, respiratory diseases and allergies.
Intervention groups
Patients in the intervention group will smell lavender-scented napkins for 3 minutes.
Main outcome variables
Pain and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220408054454N2
Registration date:2024-08-04, 1403/05/14
Registration timing:prospective
Last update:2024-08-04, 1403/05/14
Update count:0
Registration date
2024-08-04, 1403/05/14
Registrant information
Name
Amene Abiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 709 0424
Email address
abiri@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2026-09-06, 1405/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aromatherapy with lavender on the pain intensity during the active phase of physiological labor in primiparous women referred to Arash Hospital.
Public title
The effect of aromatherapy with lavender on the pain intensity of the active phase of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age of term
Live singleton fetus with cephalic presentation confirmed by ultrasound
Examination of dilatation on arrival 4 cm
No medical problems or pregnancy complications
Lack of mental illnesses that can cause non-participation of the patient
Absence of respiratory diseases and allergies
Functioning sense of smell
Body mass index greater than 19 and less than 26
Being literate
Exclusion criteria:
Mother's unwillingness to participate in the study
Low level of consciousness
Umbilical cord prolapse
Placental abruption
Preeclampsia
Professional athletes
Consumption of psychoactive substances
Receiving painkillers or sedatives 3 hours before the study
History of infertility
History of eczema
History of allergy to plants
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, to make sure that the same number of participants are allocated to both groups (lavender group and placebo group), block randomization with a block size of 4 with a ratio of 1:1 will be used. A list of 4-person blocks will be created randomly using Stata 17.0 software. This makes the number of people in each group the same, unlike simple randomization, and the power of the study is maximum.
Blinding (investigator's opinion)
Double blinded
Blinding description
The scented napkins of both groups are the same and the patient will not be aware of his group. Lavender-scented napkins and water-soaked napkins (placebo) will be prepared by one of the operating room personnel who is not in contact with others and will be provided to the interventionist. The midwife/doctor applying the intervention will not know about the patient group. Also, the midwife/physician who measures the outcomes will not know the patient allocation. The data analyst will also be blinded to the allocation of subjects.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex
Street address
Imam Khomeini Hospital Complex, Dr. Gharib St., At the end of Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.042
Health conditions studied
1
Description of health condition studied
Anxiety caused by colposcopy
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety caused by colposcopy
Timepoint
Before intervention, dilatation 5-6, 7-8 and 9-10 cm
Method of measurement
Spielberger questionnaire
Secondary outcomes
1
Description
Pain
Timepoint
Before the intervention, dilation 5-6, 7-8 and 9-10 cm
Method of measurement
Pain visual analog scale
Intervention groups
1
Description
Intervention group: Inhalation of a scented handkerchief with 3 drops of lavender oil (Nice Oil Company) 3 times at 5-6, 7-8 and 9-10 cm dilatations and each time for 3 minutes.
Category
Treatment - Other
2
Description
Control group: Smelling napkins soaked with water 3 times at 5-6, 7-8 and 9-10 cm dilatations and each time for 3 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Ameneh Abiri
Street address
Shahid Baghdarnia street, after Shahid Bagheri highway, Resalat highway,
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Email
abiri@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?