Comparison of Trans-cutaneous electrical nerve stimulation (TENS) and Entonox on pain control during delivery
Design
A randomized clinical trials with control group, community and performance based with parallel group design, and 40 subjects in each group.
Settings and conduct
This study was a randomized clinical trial with three groups that was performed at the maternity ward of Ayatollah Mousavi Hospital in Zanjan. In this study, the patient was aware of the method of analgesia. Therefore, Blinding was not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primiparity; Pregnant mothers aged 45-15 years old; Gestational age more than 37 weeks; Single pregnancy; The onset of active phase of labor.
Exclude criteria: Need to emergency cesarean section
Intervention groups
Intervention group 1: the effect of TENS on labor pain. In the TENS group, mother can change the frequency of the device from low (at least pain relief) to high (maximum pain relief).
Intervention group 2: the effect of Entonox gas on delivery pain. In the Entonox group, the patient with a deep inhalation, a pause at the end of the inhalation, a slow exhalation, and then a rest continues gas inhalation. At the end of the uterine contraction, she will stop the gas inhalation and will inhale the room air.
Control group: without any intervention
Main outcome variables
Pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180707040370N4
Registration date:2019-03-26, 1398/01/06
Registration timing:retrospective
Last update:2019-03-26, 1398/01/06
Update count:0
Registration date
2019-03-26, 1398/01/06
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0496
Email address
e.jenabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
2017-10-12, 1396/07/20
Actual recruitment end date
2018-01-10, 1396/10/20
Trial completion date
2018-02-19, 1396/11/30
Scientific title
The comparison of the effect of Tens and Entonox gas on pain control in Primigravida
Public title
The effect of Trans-cutaneous electrical nerve stimulation (TENS) and Entonox gas on labor pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparity
Being at the age of 15-45 years old
Gestatinal age more than 37 weeks
Singleton pregnancy
Beginning of the active phase of delivery
Exclusion criteria:
Need to emergency cesarean section
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to the three groups of 40 recipients of TENS and Entonox gas and other group without any intervention using the Select (randbetween (1; 2)) command, in the Excel computer program.
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 Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Scienes, Azadi Blvd
City
Zanjan
Province
Hamadan
Postal code
4515613191
Approval date
2016-08-09, 1395/05/19
Ethics committee reference number
ZUMS.REC.1395.147
Health conditions studied
1
Description of health condition studied
The comparison of TENS and Entonox on delivery pain
ICD-10 code
O63
ICD-10 code description
Long labor
Primary outcomes
1
Description
Pain score
Timepoint
At the beginning of the study and at dilatations of 4-6, 6-8, 8-10 cm
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: the effect of TENS on labor pain. In the TENS group, first place the electrodes at the appropriate place behind the patient. The electrodes are parallel to the spine. The first pair of electrodes is placed between the tenth thoracic and the first lumbar vertebra. The second pair of electrodes is placed between the second to fourth sacral vertebrae. Then, mother can change the frequency of the device from low (at least pain relief) to high (maximum pain relief).
Category
Treatment - Drugs
2
Description
Intervention group 2: the effect of Entonox gas on delivery pain. In the Entonox group, we first teach to the patient how to use Enonox gas. Gas usage should begin at the beginning of uterine contraction. The capsule should be shaken before use. Gas inhalation will be continued with a deep inhalation, a pause at the end and a rest phase. By the of uterine contraction, the gas inhalation will be stopped and the patient will use the room air. We will stopp using Entonox when the patient won't cooperate or the level of the patient's consciousness will be decreased.
Category
Treatment - Drugs
3
Description
Control group: without any intervention
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternity ward of Mousavi Hospital in Zanjan
Full name of responsible person
Behnaz Molaei
Street address
Mousavi Hospital, Gavazang Ave
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3313 0001
Email
molaei@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi Blvd
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0677
Email
shoghli@zums.ac.ir
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
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
Zanjan University of Medical Sciences
Full name of responsible person
Behnaz Molaei
Position
ََAssociate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zanjan University of Medical Sciences, Azadi Blvd
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0677
Email
molaei@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Behnaz Molaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zanjan University of Medical Sciences, Azadi Blvd
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0677
Email
molaei@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
انسیه جنابی
Position
Associate proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
City
Hamadan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Email
en.jenabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
A portion of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Any analysis on the data is allowable with the source citation.
From where data/document is obtainable
Zanjan University of Medical Sciences
What processes are involved for a request to access data/document