Determination of the Effect of solvia Oil by Massage and Aromatherapy on intensity of labor Pain in Primiparous Women
Design
28 people in each group were evaluated and 10% drop, the sample size was 32 in each group and 96 in each group. Also, the division of samples into groups is completely randomized using 6 blocks.
Settings and conduct
The population under study is all primiparous women who come to the Besat Hospital in Sanandaj for delivery at the time of sampling and have criteria for entering the study.
Participants/Inclusion and exclusion criteria
The study population is all primiparous women who come to the Besat Hospital in Sanandaj for the purpose of delivery at the time of sampling and have criteria for entering the study women aged 18-40, gestational age between 37-37 weeks, dilation 4-3 Centimeters, at least literate reading and writing, represent the head of the fetus.
Intervention groups
The group in this study is generally the intervention group (A, B) and control (C):
1. Group A: Group A (Aromatherapy with solvia oil) In this group, women smell the herbal syringe with 10% bean oil for 20 minutes. The pain intensity is recorded after 20 minutes.
2.Group B (Massage Therapy with solvia oil) In this group, women receive 20% of the back massage by using an apple juice extract of 10% for 20 minutes, and the intensity of pain is recorded after 20 minutes.
3. Group C (control) In this group, women will receive routine care and no intervention will be given to them. 20 minutes later, the severity of the pain is felt and recorded.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190322043098N1
Registration date:2019-04-27, 1398/02/07
Registration timing:registered_while_recruiting
Last update:2019-04-27, 1398/02/07
Update count:0
Registration date
2019-04-27, 1398/02/07
Registrant information
Name
Bahare Noori monfared
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4612 9104
Email address
norimonfared.b@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-19, 1398/01/30
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Solvia oil in two methods of Massage and Aromatherapy on intensity of labor pain in primiparous women
Public title
Comparison of the effect of Solvia oil in two methods of Massage and Aromatherapy on intensity of labor pain in primiparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
Women aged 40-18
Pregnancy age between 42-37 weeks
4-3 cm dilatation
At least reading and writing skills
Having a natural garden before studying
Not having a midwife along
Exposure to the embryo
Not having diseases like cancer, lumbar disc disease, high blood pressure, seizures, diabetes, high fever, infectious disease,
Exclusion criteria:
Rupture more than 6 hours a bottle of water
Get anorexia three hours before the study begins
Multiplayer women
Known mental illness
Surgery of the spine in the last three months
The occurrence of any stressful event involving the separation of the spouse, the death of the loved ones within the past six months
Drug Addiction and Psychosocial
History of sensation and allergy to fragrances
Third-trimester bleeding
Abortion history
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
---Examples of each group for the statistical counselor will be unknown.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences Pasdaran Blvd,
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Approval date
2019-03-19, 1397/12/28
Ethics committee reference number
IR.MUK.REC.1397.387
Health conditions studied
1
Description of health condition studied
-
ICD-10 code
ICD-10 code description
-
Primary outcomes
1
Description
The severity of labor pain is measured based on a pain reliever
Timepoint
-In dilates of 5-4, 7-6 and 8-10 cm cervix before and after intervention in the studied groups
Method of measurement
Based on the visual scale of the pain, which is a 10-cm ruler, the zero number on the left indicates no pain and the number 10 on the right
Secondary outcomes
empty
Intervention groups
1
Description
1. Group A: Group A (aromatherapy with solvia oil) In this study, women have a sensation of 5-4, 7-6, and 10-8 cm dilatations. The herbal scent is smeared with 10% bean oil for 20 minutes, and the severity of pain after 20 Minutes are recorded.
Category
Rehabilitation
2
Description
Group B: Group B (Massage Therapy with solvia oil) In this study, women who have been treated with an extract of essential oil in a 4x4, 7-6, and 10-8cm dilates for 20 minutes, 10 percent made by Healing Kurdistan Corporation. And the severity of pain is recorded after 20 minutes.
Category
Rehabilitation
3
Description
Control group: In the study, the group C (control) in this study is women who have routine care in dilates 5-4, 7-6 and 10-8
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Bahareh Noori Monfared
Street address
Keshavarz Street, Meroux
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3328 5910
Email
Nouri.b1365@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzin Rezaei
Street address
Kurdistan University of Medical Sciences, Pasdaran Boulevard
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 6633 5346
Email
f.rezaee@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Bahareh Noori Monfared
Position
Master Student Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Pasdaran Boulevard, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
Nouri.b1365@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Farzaneh Zaheri
Position
Master's assistant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Pasdaran Boulevard, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4653
Email
f.zaheri1968@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Bahareh Noori Monfared
Position
Master of Science in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Pasdaran Boulevard, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
Nouri.b1365@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the effect of the herbal extracts on the severity of labor pain will be released.primiparous women admitted to the delivery ward of Beasat Hospital in Sanandaj in 2019.
When the data will become available and for how long
-Start the access period 6 months after printing the results
To whom data/document is available
-Researchers working in academic institutions and pharmaceutical companies
What processes are involved for a request to access data/document
-After accessing the data and verifying the request by the researcher and the research executor, data is provided to individuals or institutions within at least three months.