Comparison of the effect of lumbar rotation in standing position and pressure on the 6th splenic point in the active phase on pain severity, duration of labor and childbirth experience of nulliparous women
Comparison of the effect of lumbar rotation in standing position and pressure on the 6th splenic point in the active phase on pain severity, duration of labor and childbirth experience of nulliparous women
Design
Random clinical trial with two intervention groups and one control group on 126 nulliparous women. The samples will be randomly divided into three groups.
Settings and conduct
Nulliparous women with inclusion criteria who are admitted to the maternity ward of Bent Al-Hoda Hospital in Bojnourd at a specified time for delivery are randomly assigned to one of the three intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria : 18-35 years of old ؛ First pregnancy؛ Gestational age 38-42 weeks, Cephalic presentation؛ Spontaneous onset of labor pains and dilatation of 4 cm of the cervix when entering the study؛ Desire and readiness for physiological delivery؛ No known chronic medical diseases؛ Fetal health according to ultrasound findings or prenatal tests
Exclusion criteria :All mothers who were excluded from labor and natural childbirth due to maternal or fetal causes ؛ Taking painkillers or accelerators of labor during the study؛ Occurrence of hypertonic uterine contractions؛ Mother’s unwillingness to continue participating in the study
Intervention groups
Rotation of the lumbar in a standing position: in dilatation of 4 cm, she is placed in a standing position and bends forward with the onset of pain and, leaning against the wall, rotates the lumbar for 30 minutes during each contraction; Pressure on 6th splenic point : In 3-4 cm dilatation with the onset of uterine contraction, bilateral pressure is applied in a circular fashion and clockwise with the researcher's thumbs on 6th splenic point ; Control: Routine care is performed.
Main outcome variables
Severity of labor pain; Duration of delivery; Childbirth experience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201213049699N1
Registration date:2021-01-07, 1399/10/18
Registration timing:prospective
Last update:2021-01-07, 1399/10/18
Update count:0
Registration date
2021-01-07, 1399/10/18
Registrant information
Name
Elham Shirdel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3226 0097
Email address
eshirdel@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-09, 1399/10/20
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of lumbar rotation in standing position and pressure on the 6th splenic point in the active phase on pain severity, duration of labor and childbirth experience of nulliparous women
Public title
Comparison of the effect of lumbar rotation in standing position and pressure on the 6th splenic point in the active phase on pain severity, duration of labor and childbirth experience of nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18-35 years of old
First and singleton pregnancy
Gestational age 38-42 weeks, Cephalic presentation
Spontaneous onset of labor pains and dilatation of 4 cm of the cervix when entering the study
The estimated weight of the fetus according to Johnson's law is between 2500-4000 grams
Desire and readiness for physiological delivery
No known chronic medical diseases (Mental disorders, Skeletal and Anatomical disorders, Skin diseases such as Eczema and Inflammation in the area of pressure, High Fever, Phlebitis, Thrombosis)
Fetal health according to ultrasound findings or prenatal tests
Exclusion criteria:
All mothers who were excluded from labor and natural childbirth due to maternal or fetal causes such as Abruption, Umbilical cord prolapses, and Fetal distress
Taking painkillers or accelerators of labor during the study
Occurrence of hypertonic uterine contractions
Mother’s unwillingness to continue participating in the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was performed by Permuted block randomization method. Due to the three groups, the study is designed in six order with the letters B, A and C. After selecting a card by someone other than the researcher, the order of the 3 groups is specified and removed from the total number of cards. Card A: Rotation of the back in a standing position (intervention group) Card B: Pressure on the splenic point 6 (intervention group) Card C: (Control group).
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 Tehran University of Medical Sciences
Street address
Room 605, 6th Floor, Tehran University of Medical Sciences Headquarters Building, Intersection of Keshavarz Boulevard and Ghods Street
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.889
Health conditions studied
1
Description of health condition studied
Severity of labor pain
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Duration of labor
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Childbirth experience
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of labor pain: The amount of labor pain that is expressed by mother and is different in women during labor and its amount is determined only by mother
Timepoint
Before the intervention, immediately after the first and second intervention in each group
Method of measurement
Standard tool for determining pain score based on Analog Visual Scale
2
Description
Duration of active phase: From the beginning of cervical dilatation of 3-6 cm in the presence of uterine contractions to dilatation of 10 cm during labor
Timepoint
From dilatation of 3 to 6 cm to dilatation of 10 cm of the cervix
Method of measurement
With timer seconds
3
Description
Duration of the second stage of labor: The second stage of labor ends with complete dilatation of the cervix beginning with labor and fetal delivery
Timepoint
From complete dilatation of the cervix to delivery and complete removal of the fetus
Method of measurement
With timer seconds
4
Description
Childbirth experience: Pleasant or unpleasant experience for women during pregnancy, labor and childbirth
Timepoint
Within 2 hours after delivery
Method of measurement
Childbirth Experience Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Rotation of the lumbar in a standing position: in dilatation of 4 cm, she is placed in a standing position and bends forward with the onset of pain and, leaning against the wall, rotates the lumbar for 30 minutes during each contraction.
Category
Behavior
2
Description
Intervention group: Pressure on the 6th splenic point: In 3-4 cm dilatation with the onset of uterine contraction, bilateral pressure is applied in a circular direction and clockwise with the researcher's thumb on the 6th splenic point
Category
Behavior
3
Description
Control group: Routine care is performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bent Al-Huda hospital
Full name of responsible person
Ziba Taghizadeh
Street address
Art Ave, Maternity Crossroads, West Taleghani Ave
City
Bojnourd
Province
North Khorasan
Postal code
9414951156
Phone
+98 58 3223 6551
Email
shirdelelham90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraian
Street address
226, Qods Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
taghizad@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ziba Taghizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Tehran University of Medical Scienc, at the beginning of East Nosrat,Towhid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Fax
Email
taghizad@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ziba Taghizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Tehran University of Medical Scienc, at the beginning of East Nosrat,Towhid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Fax
Email
taghizad@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Shirdel
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.24 and 26, Shahid Nariman Hamidizadeh Ave, North 17 Shahrivar
City
Bojnourd
Province
North Khorasan
Postal code
9415634334
Phone
+98 58 3226 0097
Fax
Email
eshirdel@razi.tums.ac.ir
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