Comparison of the effect of back massage on the duration of the first stage of labor in both case and control groups
Comparison of the effect of back massage on the duration of the second stage of labor in both case and control groups
Comparison of the effect of back massage on the duration of the third stage of labor in both case and control groups.
Design
In this study, 60 pregnant mothers who are nulliparous and eligible for admission to the Alavi Center are selected. Participants are randomly divided into two intervention and control groups and each participant is given a dedicated code.
Settings and conduct
The Type of Study will be a Clinical Trial with Two Groups of Massage and Control. The Statistical Population of Pregnant Women is at the Threshold of Delivery in Ardabil City. In this Clinical Trial Study,60 Subjects (30 Massage and 30 Controls) Were Selected from Women Referring to Ardabil Alavi Hospital with Continuous Sampling And Random Sampling. In The Massage Group, 4 Centimeters of Cervical Dilatation Will Result in Three Massage Therapies Until Delivery. control group will receive routin care.
Participants/Inclusion and exclusion criteria
The criteria for entering the study included normal pregnancy, singleton,cephalic presentation , dilatation above 4 cm, have criteria for massage, lack of participation in the physiological delivery class, exclusion criteria including mother's unwilling to continue massage, lack of massage therapy criteria
Intervention groups
The study participants will include pregnant women in the active phase of labor that will be referred to the Alavi hospital in Ardabil. Mothers will receive three half-hour massage times if they have the entry criteria and after obtaining the consent of the company in the study in dilatation 5-7 -9 cm.
Main outcome variables
Pain Intensity; Duration of Pain
General information
Reason for update
Acronym
تأثیر ماساژ
IRCT registration information
IRCT registration number:IRCT20140118016255N5
Registration date:2019-01-15, 1397/10/25
Registration timing:retrospective
Last update:2019-01-15, 1397/10/25
Update count:0
Registration date
2019-01-15, 1397/10/25
Registrant information
Name
Roya Nikjou
Name of organization / entity
Ardabil University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 45 1771 7137
Email address
roya.nikjou@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-14, 1396/11/25
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey Effectiveness of Back Massage on Process of Pain and Delivery Labor Outcomes in Primiparous Women
Public title
Effect of Back Massage on Process of Pain and Delivery Labor Outcomes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Normal and Term pregnancy
Singleton
Cephalic presentation
4 cm dilatation
Have Massage criteria
Lack of Participation in the Physiological Delivery Class
Exclusion criteria:
Mother's Withdrawal from Continue Massage
Have any illness
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization, Block
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants Will be Unaware of the Allocation of Intervention type in Two Groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
End of the University of Ardabil University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2018-01-22, 1396/11/02
Ethics committee reference number
IR.ARUMS..1396.204
Health conditions studied
1
Description of health condition studied
Labor Pain
ICD-10 code
O80-O84
ICD-10 code description
O80-O84
Primary outcomes
1
Description
Severity of Pain
Timepoint
Dilation 5-7-9 cm
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: The study participants will include pregnant women in the active phase of labor that will be referred to the Alavi hospital in Ardabil. Mothers will receive three half-hour massage times if they have the entry criteria and after obtaining the consent of the company in the study in dilatation 5-7 -9 cm. Control Group: In control group will receive routin care.
Category
Prevention
2
Description
Control group: In the control group, participants will receive routine care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi hospital
Full name of responsible person
Roya Nikjou
Street address
Hafez Square, Faculty Of Nursing And Midwifery
City
Ardabil
Province
Ardabil
Postal code
5615754136
Phone
+98 45 3372 6085
Fax
+98 45 3372 8004
Email
roya.nikjou@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Massoud Entezari
Street address
End of The University Street
City
Ardabil
Province
Ardabil
Postal code
56157-54136
Phone
+98 45 3352 2247
Email
roya.nikjou@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
2
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Massoud Entezari
Street address
End of The University Street
City
Ardabil
Province
Ardabil
Postal code
56189-8599156
Phone
+98 45 3372 8005
Email
roya.nikjou@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Roya Nikjou
Position
Lectur
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery Ardabil Shohada High way
City
Ardabil
Province
Ardabil
Postal code
56157-54136
Phone
+98 45 3372 6085
Fax
+98 45 3372 8004
Email
roya.nikjou@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Roya Nikjou
Position
Lectur
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery of Ardabil, Shohada highway
City
Ardabil
Province
Ardabil
Postal code
56157-54136
Phone
+98 45 3372 8005
Email
roya.nikjou@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Roya Nikjou
Position
Lectur
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery of Ardabil, Shohada High Way
City
Ardabil
Province
Ardabil
Postal code
56157-54136
Phone
+98 45 3372 8005
Email
roya.nikjou@arums.ac.ir
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
data held in common after anonymous
When the data will become available and for how long
unlimited
To whom data/document is available
popular
Under which criteria data/document could be used
no condition
From where data/document is obtainable
researcher
What processes are involved for a request to access data/document