The Effect of Inhaled Entonox on Pain in Pregnant Mothers
Design
A clinical trial with a control group, with parallel groups, one-sided, randomized, on 108 patients. Excel software rand function was used for randomization.
Settings and conduct
The study is a one-blind randomized clinical trial on 108 pregnant women volunteering for natural childbirth referred to Imam Khomeini Hospital in Ahvaz. Sampling will be done randomly and after obtaining the consent of pregnant women and their husbands, 54 people in the intervention group (Entonox inhalation) and 54 people in the control group (oxygen inhalation) will be included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria include primiparous, full-term and single pregnancy without any medical or obstetric complications and no prohibition of Entonox inhalation, and exclusion criteria include the occurrence of any complications during labor and delivery and the need to induce labor and cesarean section. , Will need to receive additional housing, housing during the last 8 hours or the mother's subsequent dissatisfaction for any reason.
Intervention groups
54 people enter the intervention group and receive Entonox (a combination of oxygen and nitrogen).
54 people enter the control group and receive only oxygen.
Main outcome variables
Age ; Body mass; Severity of labor pain; Duration of active phase and second phase of labor; Apgar score of the first and fifth minutes; Race and ethnicity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200815048415N1
Registration date:2020-11-01, 1399/08/11
Registration timing:registered_while_recruiting
Last update:2020-11-01, 1399/08/11
Update count:0
Registration date
2020-11-01, 1399/08/11
Registrant information
Name
Parisa Niknezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5353 0964
Email address
parisaniknezhad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2021-02-03, 1399/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Inhaled Entonox on Pain in Pregnant Mothers
Public title
The Effect of Inhaled Entonox on Pain in Pregnant Mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women
Normal vaginal delivery
First Pregnancy
Term Pregnancy
Single Pregnancy
Satisfaction of the volunteer and the volunteer spouse
Exclusion criteria:
Having any medical or obstetric complications
No ban on inhaling Entonox
Get Extra analgesic dose
Receive analgesic dose in the last eight hours
Any complication during labor and the need to induce labor
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Excel software rand function was used for randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
After explaining the study to the participant and obtaining her informed consent, the participant is placed in one of the two intervention or control groups, but has no information about the type of drug received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Jondishapur University of Medical Sciences, No 1 Esfand, Golestan Blvd,
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.005
Health conditions studied
1
Description of health condition studied
Normal delivery
ICD-10 code
O80.8
ICD-10 code description
Other Single spontaneous delivery
Primary outcomes
1
Description
Pain of delivery
Timepoint
One hour after delivery
Method of measurement
Visual scale of pain (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, women will be taught to inhale Entonox gas using a mask by placing their hands on their abdomen and touching or feeling uterine contractions, and in the interval between uterine contractions. Set aside.Entonox gas is a mixture of 50% oxygen + 50% N2O
Category
Treatment - Drugs
2
Description
Control group: Oxygen use Patients were instructed to apply an oxygen-containing mask to the nose and breathe in it as soon as uterine contractions began, and to continue to do so until the uterine contractions were complete. This continues from 4-5 cm dilatation of the cervix to complete dilatation. Oxygen is 100% oxygen
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Parisa Niknezhad
Street address
Imam Khomeini Educational and Medical Center, Azadegan St., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Jondishapur University of Medical Sciences, No 1 Esfand, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8627
Email
iitc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Artadokht khoshoei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jondishapur University of Medical Sciences, No 1 Esfand, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8627
Email
khoshoei-a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Artadokht khoshoei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jondishapur University of Medical Sciences, No 1 Esfand, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8627
Email
khoshoei-a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parisa Niknezhad
Position
Medical intrn
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Jondishapur University of Medical Sciences, No 1 Esfand, Golestan Blvd,
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8627
Email
parisaniknezhad@gmail.com
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available