Effect of massaging the waist region with ginger oil on the severity of pain in the active phase of labor in primipara women
Design
Clinical trial with two groups of intervention and one control group, with parallel, double-blind, randomized groups
Settings and conduct
With the onset of uterine contractions in dilates 4-5, 6-7, and 8-10 cm with deep breathing,The participant is placed in a sitting position or sitting, and the massage is carried out continuously during contraction for 15 minutes without contraction. For the intervention group massage the area of the waist with an appleberry with ginger oil or Paraffin oil is done. The start of intervention in the active phase and the dilatation will be 4 to 5 centimeters. Pain Questionnaire (VAS) is completed by the researcher before and immediately after the completion of each massage procedure for the intervention group (groups 1 and 2). The pain control questionnaire (VAS) of the control group will be filled out at each stage of the mentioned dilatations once a day. Place of the study: Um Al-Benin Maternity Hospital affiliated to Mashhad University of Medical Sciences
Participants/Inclusion and exclusion criteria
Satisfaction with entering the study- Iranian and resident of Mashhad- parturition prime- Single pregnancy and live
Intervention groups
Two groups of intervention (1: Gingerbread Gum Massage - 2: 1): Paraffin Paralysis (inactive) and a control group (routine nursing care during the active phase of labor) are carried out.
Main outcome variables
Determination of intensity of active phase of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039643N1
Registration date:2018-08-02, 1397/05/11
Registration timing:registered_while_recruiting
Last update:2018-08-02, 1397/05/11
Update count:0
Registration date
2018-08-02, 1397/05/11
Registrant information
Name
Marzyeh Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3868 3630
Email address
maryazizi1395@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-11-01, 1397/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of massage with ginger oil on waist circumference in reducing the pain tension at active phase of labor in primigravida
Public title
Effect ginger oil on reducing pain labor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction with entering the study
Iranian and resident of Mashhad
parturition prime
Single pregnancy and live
The age of the mother is 35- 18
No history of eczema and allergy to medicinal herbs
No exclusion of massage
A healthy water bag or less than 12 hours of water rupture
Cephalic presentation
Exclusion criteria:
twin pregnancy
Alcohol and Drug Addiction
Company dissatisfaction with the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked Block: The blocking method will be performed in such a way that: Given that this research is a triple group, then the groups will be initially named A, B, and C. Then, create 6 blocks (ABC -ACB-BCA-BAC-CAB-CBA) and draw lots to arrange these × blocks to determine which blocks are first, second, .... and which six will be. Then, with the arrival of each patient, it will be clear which group should be included.
Blinding (investigator's opinion)
Double blinded
Blinding description
The same packing and oil coding will be done by the pharmacist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University Street, Quraishi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
91735951
Approval date
2018-07-11, 1397/04/20
Ethics committee reference number
IR.MUMS.REC.1397.094
Health conditions studied
1
Description of health condition studied
Labor pain
ICD-10 code
XV
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Severity of pain in the active phase of labor in primipara women
Timepoint
The time intervals of pain measurement with the Visual Analogue Scale are performed before and immediately after each massage at each group (group 1 and 2), and in the control group, in the dilatation,4-5 /6-7 /8-10
Method of measurement
Measuring pain intensity with the Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group: the beginning of intervention in the active phase and the dilatation is 4 to 5 centimeters. How to do massage in this way, with the onset of the contraction of the pain in the intervention group, 10 to 15 drops of oil deposited in the closed containers A or B, and its materials for the researcher and the mothers can not be understood. (2% ginger or paraffin oil) in the area, and the mass of the sacral vertebra ends in the upstream to the lumbar vertebrae. Ginger extract will be prepared from the company and will then be delivered to the laboratory with base oil at a concentration of 2%.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Women of Umm Al Binhayn Hospital
Full name of responsible person
Ms. Dr. Mir Tameori
Street address
Crossroad of Zarrine, Ayatollah Behjat 16
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۴۴۷۳۴۷۵۶
Phone
+98 51 3223 1061
Email
oah.it@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
صدیقه یوسف زاده
Street address
University of Mashhad, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۹۱۳۱۹۷۳۱۹
Phone
+98 51 3859 1511
Email
YousefzadehS@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
marzyeh azizi
Position
Senior midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 5,sayad shyrazi 5,vakil abad
City
mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۶۹۳۴۸۹
Phone
+98 51 3868 3630
Email
maryazizi1395@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzyeh azizi
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 5,sayad shyrazi 5,vakil abad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۶۹۳۴۸۹
Phone
+98 51 3868 3630
Email
maryazizi1395@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzyeh azizi
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 5,sayad shyrazi 5,vakil abad
City
Mashhad
Province
Razavi Khorasan
Postal code
9179693489
Phone
+98 51 3868 3630
Email
maryazizi1395@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available