Determining the effect of vitamin E and vitamin D on the severity of postpartum painin women referred to Shahidan Mobini Hospital affiliated to Sabzevar University of Medical Sciences in 1401
Design
The clinical trial has a parallel control group, unblinded, randomized, on 100 mothers, the method of randomization: based on the days of the week, they will be divided into two intervention groups (even days) and a control group (odd days).
Settings and conduct
The study was conducted by the researcher using the selection of patients based on the provided guide in Shahidan Mobini Hospital affiliated to Sabzevar University of Medical Sciences.
Participants/Inclusion and exclusion criteria
18-35 years; Natural birth and first or second birth; Gestation age 37-42 weeks; Breastfeeding mother; Spontaneous placental discharge; So moderate to severe pain; Absence of grade 3 or 4 perineal tear; No epidural or spinal anesthesia
Not using narcotic drugs before or during childbirth; No chronic diseases; No history of abdominal and pelvic surgery
Absence of symptoms and history of D3 deficiency.
Intervention groups
In the intervention group, 8 pieces of vitamin E with a dose of 100 mg and 8 pieces of vitamin D with a dose of 400 mg will be provided to the samples.
No intervention will be done in the control group. First, 2 hours after delivery, the intensity of postpartum pain will be measured with a McGill ruler.
People with grades 4 and above will be selected.In both groups, the severity will be measured and recorded once 2 hours after delivery and before taking the pills and eight times after taking the medicine and if the pain is not relieved one hour after each intervention, a 250 mg dose of mefenamic acid will be given
Main outcome variables
Improvement of postpartum pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220313054270N1
Registration date:2022-11-01, 1401/08/10
Registration timing:registered_while_recruiting
Last update:2022-11-01, 1401/08/10
Update count:0
Registration date
2022-11-01, 1401/08/10
Registrant information
Name
mina ghalenovi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 6958
Email address
minaghalenovi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-11, 1401/07/19
Expected recruitment end date
2022-12-10, 1401/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vitamin D and Vitamin E on the severity of postpartum pain
Public title
The effect of Vitamin D and Vitamin E on the severity of postpartum pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The mother must be literate.
The age of the mother should be between 18-35 years.
Their delivery is natural and the first or second delivery.
Pregnancy age is between 42-37 weeks.
The mother is breastfeeding.
The exit of the placenta and the curtains is done spontaneously.
The mother has moderate to severe back pain.
Exclusion criteria:
The mother has not suffered a grade 3 or 4 perineal rupture.
Epidural or spinal anesthesia is not used.
During or before delivery, the drug has not been used to relieve pain, or 4 hours or more have passed since its us
The mother should not be addicted to drugs.
The mother does not have known chronic diseases (hypertension, diabetes, heart disease, infectious disease, lung disease, asthma)
The mother has no history of abdominal and pelvic surgery
The mother should not have symptoms of vitamin D deficiency (including bone and muscle pain, headache, and constant fatigue
The patient has no history of vitamin D3 deficiency.
Age
From 18 years old to 35 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
43
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the days of the week, the research units will be divided into two groups A (intervention group) (Saturdays, Mondays, Wednesdays) and group B (control groups) (Sundays, Tuesdays, Thursdays).
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 Sabzevar University of Medical Sciences
Street address
Nuclear Martyrs Ave, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2021-11-20, 1400/08/29
Ethics committee reference number
IR.MEDSAB.REC.1400.111
Health conditions studied
1
Description of health condition studied
postpartum pain
ICD-10 code
Z39.2
ICD-10 code description
Encounter for routine postpartum follow-up
Primary outcomes
1
Description
Severity of postpartum pain
Timepoint
2 hours after delivery and then every 6 hours up to eight times
Method of measurement
Through the McGill pain scale (to reach less than 4 after the intervention)
Secondary outcomes
1
Description
The amount of painkillers used
Timepoint
2 hours after delivery and then every 6 hours, the consumption of painkillers is checked
Method of measurement
patient file
2
Description
The amount of pain
Timepoint
2 hours after delivery and then every 6 hours up to 8 times
Method of measurement
Via McGill ruler
Intervention groups
1
Description
Intervention group: each person receives a packet containing 8 vitamin E with a dose of 100 mg and 8 vitamin D with a dose of 400 mg. and every 6 hours, they take one vitamin D and one vitamin E, and after every 6 hours, for 8 times. the pain level is measured by the McGill ruler.
Category
Treatment - Drugs
2
Description
Control group: It does not receive any interference. Routine hospital care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahidan Mobini Hospital affiliated to Sabzevar University of Medical Sciences
Full name of responsible person
Fatemeh Nodeh
Street address
North Kashfi Ave.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613856776
Phone
+98 51 4423 8102
Email
Mobini.H@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Hosein Saghi
Street address
Nuclear Martyrs Ave, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8101
Email
vc.Research@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mina Ghalenovi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nuclear Martyrs Ave, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613943491
Phone
+98 51 4422 6958
Email
Minaghalenovi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mina Ghalenovi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nuclear Martyrs Ave, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613943491
Phone
+98 51 4422 6958
Email
Minaghalenovi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mina Ghalenovi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nuclear Martyrs Ave, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613943491
Phone
+98 51 4422 6958
Email
Minaghalenovi@yahoo.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
After the publication of the article, confidential information such as patient and hospital details will be removed and other information will be provided to the researchers
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Medical experts
Under which criteria data/document could be used
Medical professionals can access the data for research purposes
From where data/document is obtainable
Refer to the email of the responsible author.
What processes are involved for a request to access data/document
Official and academic email to the corresponding author