Protocol summary

Summary
The aim of this study is the effect of Zataria multiflora boiss capsule on postpartum pain. It is a clinical, trial, randomized, and double-blind research will be done on 105 mothers, with normal vaginal deliveries. Inclusion criteria: 18-35 years of age; after at last 2 hours of their childbirth; gestational age is between 37-42 weeks; with no medical conditions; not high-risk pregnancy; no problem at childbirth; having moderate to severe pain. Exclusion criteria: Mother needs surgery and postpartum anesthesia received after the delivery; mother is suffering from serious complications after delivery. Shirazi thyme capsule, ibuprofen, and acetaminophen are uniformly and with codes A and B and C will be put in envelopes by the pharmacist and, then, based on random numbers will be given to individuals. Mothers, from 2 hours to 24 hours after delivery, will be studied in postpartum care unit of Ahvaz Imam Khomeini hospital. Before the intervention, the amount of pain will be measured and recorded with pain ruler and, then, the mothers will be given the first capsule and an hour after intervention, the mother's pain will measured and recorded with pain ruler again. Next capsules will be given to mothers every 6 hours and on their request.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071128876N1
Registration date: 2017-01-03, 1395/10/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-03, 1395/10/14
Registrant information
Name
Ladan Parsa
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
ladan.parsa@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-07-31, 1395/05/10
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Scientific title
The effect of Zataria multiflora boiss capsule on postpartum pain
Public title
The effect of Zataria multiflora boiss capsule on postpartum pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Iranian Mothers; speak Persian; having any communication problem; with at least literacy of writing and reading; live with his husband at the moment; the delivery must be vaginal and natural; the baby must be alive, singleton, and without malformations; gestational age must be between 37-42 weeks; it must be 2 hours after the mother's delivery; mother must complain about the labor and post-delivery pain; have moderate to severe post-delivery pain; be willing to take the painkiller; it must not be a high-risk pregnancy; delivery with no problems; the mother is able to take the drug orally; has the ability to breast-feed the baby; the baby must be able to suck the mother's breast; to relieve pain, mother must have taken no other medications at the time of hospitalization; she must be unaffected by medical conditions; she must not be taking long-term medications; she must have no history of cesarean section or abdominal surgery; not have the history of allergy to non-steroidal anti-inflammatory drugs and to acetaminophen; not have a history of sensitivity to herbal medicines and spices; she must not be addicted to drugs; the drugs or methods of analgesia must not be used during delivery. Exclusion criteria: Mother needs surgery and postpartum anesthesia received after the delivery; mother is suffering from serious complications after delivery; continuation of breastfeeding is not possible due to causes related to mother or baby; mother has any side effects associated with the studied drugs; mother, for any reason, is unwilling to continue the study.
Age
From 17 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
None
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random numbers using excel software

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
shahid Beheshti University of Medical Sciences
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1985717443
Approval date
2016-04-17, 1395/01/29
Ethics committee reference number
IR.SBMU.RAM.REC.1395.82

Health conditions studied

1

Description of health condition studied
postpartum afterpains
ICD-10 code
z39
ICD-10 code description
Postpartum care and examination

Primary outcomes

1

Description
postpartum afterpains
Timepoint
Before intervention,An hour after taking the capsules,Time to feel relief from pain.
Method of measurement
Pain ruler

Secondary outcomes

1

Description
Possible side effects of intervention
Timepoint
At the end of the intervention period
Method of measurement
At the end of the intervention period

Intervention groups

1

Description
Intervention group: Capsule Zataria multiflora every 6 hours for 24 hours
Category
Treatment - Drugs

2

Description
Control group: capsule of ibuprofen every 6 hours for 24 hours
Category
Treatment - Drugs

3

Description
Control group: capsule of paracetamol every 6 hours for 24 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ladan Parsa
Street address
Imam Khomeini Hospital,Azadegan St.Ahvaz.Khozestan.Iran.
City
Ahvaz
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ladan Parsa
Position
Master's student of Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
ladan.parsa@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gity Ozgoli
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1985717443
Phone
+98 218865536671
Fax
+98 21 8820 2521
Email
sbnmf@sbmu.ac.irmhdolatian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ladan Parsa
Position
master's student of midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran.
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
ladan.parsa@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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