Comparison of the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Acupuncture Points (Hegu and Sanyinhiao) on Duration, labor Pain Intensity and Need for Induction of the First Stage of Labor: A Clinical Trial
Determining and comparing the effect of percutaneous electrical nerve stimulation in Hugo and San Injiao districts on the duration and severity of pain and the need for induction
Design
.In this study, a portable two-channel TENS device with two pairs of electrodes (Max Tens 2000) will be used. Before the intervention (dilation 3-5 cm), the intensity of pain in the three groups will be measured and recorded. In first group, two electrodes will be placed on the Hugo points on both hands, and in second group, two other electrodes will be placed on the San-Injiao points in both feet. In two groups, the device will be set with continuous current, frequency of 100 Hz per minute and wavelength of 250 microseconds, and will be alternately turned on for 20 minutes and turned off for 20 minutes, and will continue until the end of the second stage of labor (dilation of 10 cm to the exit of the fetus).
Settings and conduct
This study will be conducted on women in labor to assess the effect of TENS in Mousavi hospital in Zanjan. participants will be blinded.
Participants/Inclusion and exclusion criteria
Age 35-18 years.
BMI below 30
Height above 150
Absence of pelvic stenosis based on examination by a researcher and Ankal doctor
Gestational age is 42-37 weeks.
Be primiparous.
Intervention groups
Samples are randomly entered into three groups of 42, so that in order to randomize the selection of samples by simple randomized method in one of the intervention groups 1 Hugo point , intervention 2 San-Ingiao or placebo group Placed.
Main outcome variables
Reducing pain intensity, reducing labor duration, reducing the need for induction in the active phase of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220221054085N1
Registration date:2022-10-27, 1401/08/05
Registration timing:registered_while_recruiting
Last update:2022-10-27, 1401/08/05
Update count:0
Registration date
2022-10-27, 1401/08/05
Registrant information
Name
sanaz Fayazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8373
Email address
sanazfaiiazi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Acupuncture Points (Hegu and Sanyinhiao) on Duration, labor Pain Intensity and Need for Induction of the First Stage of Labor: A Clinical Trial
Public title
Comparison of the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Acupuncture Points (Hegu and Sanyinhiao) on Duration, labor Pain Intensity and Need for Induction of the First Stage of Labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age is 18-35 years
BMI below 30
Height above 150
Gestational age is 42-37 weeks.
Be primiparous
cephalic presentation
No CPD based on examination by researcher and on-call Obstetrics
Less than 6 hours have passed since the rupture of the membranes
Education level is at least fifth elementary.
Iranian
no induction during labor
no epilepsy.
any use of painkillers since 3 hours before labor starts
Must not be a user of cardiac pacemakers
not to be addict
no skin problem or scar in the region of electrodes
contractions have started spontaneously
single fetus
no experience of using TENS before
dilatation 3-5 cm
Exclusion criteria:
no tendency to continue participating in the study
using the oxytocin or prostaglandin be necessary
using any drug during the labor
childbirth by cesarean method
allergy or burn in the region of TENS electrodes
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
124
More than 1 sample in each individual
Number of samples in each individual:
40
A nulliparous pregnant woman without experience of using tennis in the active phase of labor
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are randomly entered into three groups of 42, so that in order to randomize the selection of samples by simple lottery method in one of the intervention groups 1 (Hugo point electrical stimulation), intervention 2 (San Ingiao electrical stimulation) or placebo group Placed. َAfter assessing the participants according to inclusion criteria and taking consent, we will exclude a ball from a bag. the red ball means first group, green ball means second group, and the white one means placebo group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, one-way blinding will be performed and participants will be unaware that the device is turned on or not.
Placebo
Not used
Assignment
Parallel
Other design features
Previous studies have focused on determining the effect of the TENS device on reducing labor pain, while in this study we have tried to consider its effect on labor duration and the need to induce labor.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Zanjan university of medical sciences
Street address
No12, Khaje nasir Street,
City
Maraghe
Province
East Azarbaijan
Postal code
5513736363
Approval date
2019-06-15, 1398/03/25
Ethics committee reference number
IR.ZUMS.REC.1398.0100
Health conditions studied
1
Description of health condition studied
Pain intensity and duration of labour and the need for induction in the active phase of labor
ICD-10 code
075.8
ICD-10 code description
075.8 Other specified complications of labour and delivery
Primary outcomes
1
Description
Duration of the first stage of labor: Accurate recording of the start time of the active phase from dilatation of 4 cm to complete dilatation of the cervix (will be measured on a minute scale).
Timepoint
from dilatation of 4 cm to complete dilatation of the cervix
Method of measurement
TV
2
Description
Pain ruler is a visual tool for determining the severity of pain through self-reporting. Scores range from 0 to 10. A score of 3-0 indicates mild pain, 4-7 indicates moderate pain, and 8-10 indicates severe pain.
Timepoint
from dilatation of 4 cm to complete dilatation of the cervix
Method of measurement
macGil ruler
3
Description
According to the diagnosis of the treating physician and recording the order to start induction of labor in the patient's file
Timepoint
from dilatation of 4 cm to complete dilatation of the cervix
Method of measurement
Trans vaginal examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention groups 1 (Hugo point electrical stimulation): In this study, the portable two-channel Max Tens 2000 device, which works with a battery, will be used with two pairs of electrodes. At the beginning of the intervention, when the person is in cervical dilatation of 3-4 cm, two electrodes will be placed in the Hugo area (located in the membrane between the thumb and index finger between the junction of the first and second metacarpal bones) in both hands and with continuous current, the frequency 100 Hz per minute and a wavelength of 250 microseconds will be set and alternately on for 20 minutes and off for 20 minutes, and this will continue until the end of the second stage of labor (dilation of 10 cm to the exit of the fetus).
Category
Treatment - Devices
2
Description
Intervention 2 (San Injiao Electrical Stimulation): In this study, a portable two-channel Max Tens 2000 device that works with a battery and two pairs of electrodes will be used. At the beginning of the intervention, since the dilatation of the cervix is 3-4cm, two electrodes will be placed in the San Injiao area in both legs (at a distance of 4 fingers from the fingers of the same person above the inner ankle) and with continuous current, the frequency of 100 Hz It will be set to 250 microseconds per minute and the wavelength will be alternately on for 20 minutes and off for 20 minutes, and this will continue until the end of the second stage of labor (dilation of 10 cm to the exit of the fetus).
Category
Treatment - Devices
3
Description
Control group: Placebo: In this study, the portable two-channel Max Tens device that works with a battery and two pairs of electrodes will be used. In this group, from the time of 3-4 cm dilatation of the cervix, two electrodes will be installed on the Hugo points on the hands and two electrodes on the San Injiao points on both feet, but no electric current will be established and the client will not know about the absence of current. Because we will turn on the device. And after the completion of the second stage of labor, the electrodes will be removed.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Mousavi educational Hospital
Full name of responsible person
Sanaz Fayazi
Street address
No.46,Saee street, Sarjangaldari
City
Zanjan
Province
Zanjan
Postal code
4553736363
Phone
+98 24 3314 8375
Email
sanazfaiiazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mrs Rostamloo
Street address
Mahdavi Blv.
City
زنجان
Province
Zanjan
Postal code
4513736363
Phone
+98 24 3314 8375
Email
sanazfaiiazi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
30
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
Zanjan University of Medical Sciences
Full name of responsible person
Sanaz Fayazi
Position
Faculty member- instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
mahdavi Blv.
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3314 8375
Email
sanazfaiiazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Najmi
Position
Assistant Professor,GYN
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gavazang Blv. Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3314 8371
Email
zahranajmi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Tahere Shams Qoreishi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
mahdavi Blv
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3314 8339
Email
sanazfaiiazi@gmail.com
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
Personal information will not be identifiable after encryption.
When the data will become available and for how long
tarting 6 months after publication
To whom data/document is available
There are no restrictions on data presentation. Information can be provided after the publication of the article
Under which criteria data/document could be used
Data are presented for comparison and systematic studies
From where data/document is obtainable
To receive data, you can contact Sanaz Fayazi, az email address sanaz faiiazi@gmail.com 09128216204پ
What processes are involved for a request to access data/document
After the publication of the article, the data will be submitted within 10 days if the applicants receive an email or a call.