Determining and comparing the effect of lavender and clove essential oil on the intensity of pain and anxiety in the first stage of labor
Design
Clinical trial with control group, with parallel groups, single blind, phase3 on 159 people, random block allocation of samples
Settings and conduct
The study will be conducted in the maternity hospitals of AllamehBahloul Gonabadi Gonabad and Hashminejad Hospitals in Mashhad.After explaining and obtaining informed consent, the eligible samples are randomly divided into three aromatherapy groups with lavender, cloves and distilled water (control group).Completion of individual and midwifery questionnaires and checklist of observation and examination and aromatherapy are performed in 4-5 cm dilatation by connecting gauze impregnated with 0.2 cc of 2% solution to the collar of the samples and repeating every 15 minutes.Pain intensity(VAS) and anxiety intensity(Spielberger) are measured twice at 4-5cm dilation and 8-10cm dilation.The samples are blind of the prescribed essential oil type.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-Women with first and second pregnancy
-Having informed consent
-Gestational age 38-42w
-Cervix dilatation more than 3cm
-Normal Vaginal Delivery
-No history of asthma, allergy and sensitivity to herbal medicines and smell problems
-Absence of pregnancy and obstetrics complications
-Not suffering from known anxiety and depression and migraine
-Not receiving medical painkillers 3 hours before the start of the intervention
Exclusion criteria:
-Non-cooperation of the mother
-Leaving the natural course or emergency caesarean section
-Allergic to essential oil
Intervention groups
Three intervention groups include aromatherapy with lavender essential oil, clove essential oil and distilled water
Main outcome variables
Intensity of pain and anxiety in the first stage of childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230301057585N1
Registration date:2023-03-10, 1401/12/19
Registration timing:prospective
Last update:2023-03-10, 1401/12/19
Update count:0
Registration date
2023-03-10, 1401/12/19
Registrant information
Name
Niloofar SadeghAhmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3864 9954
Email address
sadeghahmadi.n.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of lavender and clove essential oil on the intensity of pain and anxiety of the first stage of labor
Public title
Comparison of the effect of aromatherapy with lavender and clove essential oil on labor pain and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with first and second pregnancy, aged 18-35 years, pregnant with single fetus , having a normal delivery, 38-42 weeks of pregnancy, cephalic presentation, cervical dilatation more than 3 cm.
No history of asthma, sensitivity and allergy according to mother's statements.
Absence of disease and complications of pregnancy and obstetrics (such as: pre-eclampsia - chorioamnionitis - known liver, gallbladder and respiratory disease, decollement and abnormal heartbeat of the fetus at the beginning of the study),
Not having smell problems and allergies to herbal medicines according to the person.
Not having a known anxiety and depression disease according to the person's statements in the medical history and the mother's file.
Not having migraines according to the mother's statements in the medical history.
Not receiving medical painkillers 3 hours before the start of the study.
There is no history of infertility and thyroid disease according to the person's statements in the medical history and the mother's file.
Informed consent of women to participate in the study
Exclusion criteria:
Mother's non-cooperation in completing the checklist and expressing her pain
Departure from the natural course of labor
Having an emergency caesarean section
Allergic to essential oil
Fetal weight less than 2.5 kg or more than 4 kg
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
159
Randomization (investigator's opinion)
Randomized
Randomization description
The samples of this study are selected using an easy and accessible sampling method And to allocate the samples to the studied groups, the block random allocation method will be used.For this purpose, the "blockran" package was used in R statistical software.In the relevant function in this package, the number of treatments was 3 and the volume of the block was 6, and then the studied samples were assigned to groups using the random sequence generated by the random blocks of 6.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants are aware of the intervention, but they do not know the type of essential oil they are prescribed (lavender, clove or distilled water).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
No. 514, North Building, Parsian Tower, Amoozegar 37 Ave, Amoozegar Blvd, Mashhad City
City
Mashhad
Province
Razavi Khorasan
Postal code
9188173282
Approval date
2023-02-13, 1401/11/24
Ethics committee reference number
IR.GMU.REC.1401.184
Health conditions studied
1
Description of health condition studied
pain and anxiety of the first stage of labor
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Labor Pain score
Timepoint
At the beginning of the study, dilation 4-5 cm , dilatation 8-10 cm
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Anxiety score
Timepoint
At the beginning of the study, dilation 4-5 cm , dilatation 8-10 cm
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: Aromatherapy with lavender essential oil with a concentration of 2% was purchased from Barich Essential Oil Company, which is impregnated with gas to the extent of 0.2 cc and attached to the collar of the participants' clothes, and its prescription is repeated every 15 minutes, and they are asked to breathe normally.
Category
Treatment - Drugs
2
Description
Second Intervention group: Aromatherapy with clove essential oil with a concentration of 2% was purchased from Barich Essential Oil Company, which is impregnated with gas to the extent of 0.2 cc and attached to the collar of the participants' clothes, and its prescription is repeated every 15 minutes, and they are asked to breathe normally.
Category
Treatment - Drugs
3
Description
Control group: In the control group, 0.2 cc of distilled water is impregnated with gas and attached to the collar of the participants' clothes, and its prescription is repeated every 15 minutes, and they are asked to breathe normally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Hasheminezhad hospital
Full name of responsible person
Niloofar SadeghAhmadi
Street address
No. 514, North Building, Parsian Tower, Amoozegar 37 Ave, Amoozegar Blvd, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9188173282
Phone
+98 51 3864 9954
Email
Niloofarahmadi97@gmail.com
2
Recruitment center
Name of recruitment center
Gonabadi Allame Bohlool Hospital
Full name of responsible person
Niloofar SadeghAhmadi
Street address
No. 514, North Building, Parsian Tower, Amoozegar 37 Ave, Amoozegar Blvd, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9188173282
Phone
+98 51 3864 9954
Email
Niloofarahmadi97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Niloofar SadeghAhmadi
Street address
No. 514, North Building, Parsian Tower, Amoozegar 37 Ave, Amoozegar Blvd, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9188173282
Phone
+98 51 3864 9954
Email
Niloofarahmadi97@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Niloofar SadeghAhmadi
Position
Master of Science student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 514, North Building, Parsian Tower, Amoozegar 37 Ave, Amoozegar Blvd, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9188173282
Phone
+98 51 3864 9954
Email
Niloofarahmadi97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Niloofar SadeghAhmadi
Position
Master of Science student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 514, North Building, Parsian Tower, Amoozegar 37 Ave, Amoozegar Blvd, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9188173282
Phone
+98 51 3864 9954
Email
Niloofarahmadi97@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Niloofar SadeghAhmadi
Position
Master of Science student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 514, North Building, Parsian Tower, Amoozegar 37 Ave, Amoozegar Blvd, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9188173282
Phone
+98 51 3864 9954
Email
Niloofarahmadi97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on main outcomes in participant data after de-identification of individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The necessary conditions for requesting data include the applicant's profile, the reason for the request, and how to use it.Then the requested items are sent with the opinion of the authors.