Comparing the effect of acupressure in the point LI-4 with or without ice on the pain and anxiety levels, stress during labor: a randomised ocontrolled Trial and a meta-analysis
Determination the effect of acupressure with or without ice on pain labor and anxiety during labor
Design
At the beginning sampling is with access method postpartum women,they will then be randomly assigned to one control and towintervention groups
Settings and conduct
This study is an experimental interventional study with pretest and post_test design and implemented in babak city valiasr hospital
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1: Age between 15_49 years 2:Being primi parous; 3: Having physical and mental health 4: 4 cm cervix dilatation and having at least two three uterine contractions in ten minutes 5: Literacy understanding numbers 6: Gestational age 38 to 40 weeks, 7:Singleton pregnancy 8: Cephalic presentation; 9:
Readiness and satisfaction to participate in the research.
Exist: 1: Threatened abortion, 2: Non-cephalic presentation or had more 2 cesarean section, 3: Intrauterine death, 4: Placentaprevia, 5: Breech presentation, 6:gestational diabetes, 7:Hyperion disorder (preeclampsia and et al), 8: if had a systemic disease during pregnancy
9: (if had a psychological disorder)
Intervention groups
The intervention group 1: In the acupressure group, 4 cm dilatation of the cervix was performed for half an hour and beginning of any uterine contraction by a researcher right hand thumb on the LI 4 region in the right hand side of patient.
The intervention group 2: in the ice bag group, for half an hour, during each contraction, the point between the two metacarpal thumb and finger pointed called the hugo area LI_4, was massaged in the right hand and left hand of patient with a small bag of ice
The intervention group 3: in the control group, only the touch of the throut without a bag of ice was touched
Main outcome variables
The pain, stress and anxiety during labor in primiparous women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180314039095N1
Registration date:2019-08-28, 1398/06/06
Registration timing:retrospective
Last update:2019-08-28, 1398/06/06
Update count:0
Registration date
2019-08-28, 1398/06/06
Registrant information
Name
Fatemeh Esmaeilinejadhasaroeie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3414 6124
Email address
fesmaeilinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of acupressure in the point LI-4 with or without ice on the pain and anxiety levels, stress during labor: a randomised ocontrolled Trial and a meta-analysis
Public title
Comparing the effect of acupressure in the point LI-4 with or without ice on the pain and anxiety levels during labor
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Being primiparous
Having physical and mental health
4 cm dilatation and having at least two to three uterine contractions in ten minutes
Literacy understanding numbers
Gestational age 38 to 40 weeks
Singleton pregnancy
Cephalic presentation
Exclusion criteria:
Being multiparous
Illiteracy
Gestational age less than 37 weeks and more than 40 weeks
Several pregnancies
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the sample from the available sampling method, we divide them into a simple randomized draw metod into two groups of intervention and control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Nursing and Midwifery Collage
City
Kerman
Province
Kerman
Postal code
7419476196
Approval date
2017-12-21, 1396/09/30
Ethics committee reference number
IR. KMU.REC.1396.1655
Health conditions studied
1
Description of health condition studied
Anxiety and pain during labor
ICD-10 code
Ooo _O99
ICD-10 code description
بیماری های بارداری، زایمان و نازایی
Primary outcomes
1
Description
Pain labor
Timepoint
Before the intervention and after the completion of the intervention
Method of measurement
Visual analog scale Questionnaire
Secondary outcomes
1
Description
Stress and anxiety
Timepoint
Before the intervention and after the intervention is completed
Method of measurement
Questionnaire spilberger
Intervention groups
1
Description
The intervention group 1 : with his thumps on the Acupressure LI 4 point, both hands were rotated in the clockwise directio.
Category
N/A
2
Description
Intervention group 2 : using a piece of ice with the fingers her thumbs on the Acupressure LI 4 point were both rotated in the clockwise direction.
Category
N/A
3
Description
Control group: only the two handed fingers touched during uterine contraction.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Shahrbabak Hospital Kerman University of Medical Sciences
Full name of responsible person
Arash Sharifian
Street address
Jahad Blvd
City
Shahrbabak
Province
Kerman
Postal code
7751651159
Phone
+98 34 3411 2050
Fax
+98 34 3411 5003
Email
m24672@yahoo.com
Web page address
http://kmu.ac.ir/fa/shahrbabakhcn/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Reza Rashidi Nezhad
Street address
Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 0057
Email
Hr_rashidinejad@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Firoze Mirzaee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Collage
City
Kerman
Province
Kerman
Postal code
7619613555
Phone
+98 34 3132 5219
Email
f_mirzaee@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Esmaeilinejad Hasaroeih
Position
Master degree Student in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrbabak, Shora Blvd,
City
Kerman
Province
Kerman
Postal code
7754154444
Phone
+98 34 3414 6124
Email
nasimesmaeilinejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firoze Mirzaee
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Haftbagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
f_mirzaee@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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