Determination of the effects of acupuncture in the prevention of nausea and vomiting after cesarean section
Design
Clinical trial with control group, with parallel groups, on 99 patients.
Settings and conduct
This study will be performed in Khatam Al-Anbia Hospital in Shahroud. Group (A) will be treated with acupuncture. To group (b) We will give metoclopramide (10 mg or 15.0 kg / mg ampoule). Group (c) will also be witnesses.Next we will examine nausea and vomiting. The location of the needles will be as follows:
GB20: head difference (one number)
Shenmen: small triangle above the eardrum (half of the trunk of the upper roof of the eardrum) (2 pcs)
Li4: crease between thumb and forefinger tangential to palm (2 pcs)
PC6: Wrist crease (2 (2cun finger)) higher than wrist crease adjascent to palmaris longus tendon(2pcs)
Participants/Inclusion and exclusion criteria
Inclusion criteria included: Patient informed consent, Single pregnancy, Multipariet (after cesarean section) and without any organ disease and Exclusion criteria including a history of recent nausea and vomiting (due to any disease), Noli Parity, History Use of recent anti-nausea, antihypertensive, sedatives and H2 antagonists, history of postoperative nausea and vomiting, substance or drug abuse addicts, and unwillingness to continue cooperation.
Intervention groups
Pregnant mothers will be divided into 3 groups of 33 people. Group (a) will be treated with acupuncture. To group (b) We will give metoclopramide (10 mg or 15.0 mg/kg ampoule). Group (c) will also be witnesses.
Main outcome variables
Prevention of nausea and vomiting after spinal anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201219049770N1
Registration date:2021-01-12, 1399/10/23
Registration timing:registered_while_recruiting
Last update:2021-01-12, 1399/10/23
Update count:0
Registration date
2021-01-12, 1399/10/23
Registrant information
Name
Nasim Firouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 8670 5503
Email address
najibfarrokhy@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-23, 1398/11/03
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
acupuncture effects in the prevention of nausea and vommiting after spinal anesthesia
Public title
The effect of acupuncture on the prevention of nausea and vomiting after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient informed consent
Single term pregnancy
Multipariety (second cesarean section onwards)
Without any organ disease
Exclusion criteria:
A recent history of nausea and vomiting due to any illness
Nulipariety
History of taking antiemetic drugs
History of taking antihypertensive drugs
History of taking sedatives
History of postoperative nausea and vomiting
Addicts with drug or drug use
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Islamic Azad University-Shahrood branch
Street address
Khatamolanbial Hospital,Tehran Ave
City
Shahrood
Province
Semnan
Postal code
3614871151
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1399.009
Health conditions studied
1
Description of health condition studied
Acupuncture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of nausea and vomiting based on questions from the patient
Timepoint
Nausea and vomiting will occur in the first hour in the recovery room and in the second hour in the women's ward.
Method of measurement
Explain the nausea and vomiting to the patient and then ask about the condition
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This group will be treated with acupuncture. The location of the needles will be as follows: GB20: head difference (one number) Shenmen: small triangle above the eardrum (hemisphere of the upper roof triangle (2 pcs.) Li4: crease between thumb and forefinger tangential to palm (2 pcs.) PC6: Wrist crease (2 (2cun finger)) above the wrist crease adjacent to Palmaris longus muscle tendon (2 pcs)
Category
Prevention
2
Description
Intervention group 2: This group will be given metoclopramide (10 mg or 0.15 mg per kg body weight)
Category
Prevention
3
Description
Control group: Patients in this group do not receive any medication.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatamolanbia Hospital
Full name of responsible person
Yousef Kolookhy
Street address
Khatamolanbia Hospital,Tehran Ave
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
najibfarrokhy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behrooz Yahiaie
Street address
Khatamolanbia Hospital,Tehran Ave
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 0360
Email
behroozyahyaei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Yousef Kolookhy
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Khatamolanbia Hospita,Tehran Ave
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
najibfarrokhy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Yousef Kolookhy
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Khatamolanbia Hospital,Tehran Ave
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2660
Email
najibfarrokhy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nasim Firoozy
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Alghadir Ave,Edalat Blvd
City
Shahrood
Province
Semnan
Postal code
3619688593
Phone
+98 23 3239 2660
Email
najibfarrokhy@yahoo.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