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Study of the effect of Auriculotherapy on nausea and vomiting in women following elective cesarean section

Protocol summary

Study aim
evaluation of the effects of auriculotherapy on Nausea and vomiting in patients after cesarean section
Design
clinical trial with Two arm parallel group, single blind
Settings and conduct
This single-blind randomized clinical trial study was performed on 60 pregnant women who referred to Mashhad Omolbanin hospital for caesarean section . Participants were randomly assigned to two groups of control and intervention. In the intervention group, 30 min prior to spinal anesthesia, auriculotherapy (in shenmen, subcortex, kidney and abdominal points) was performed for 20-30 seconds by electrodermal stimulation and auricular seeds fixed on this points. In the control group, labels without seeds were attached to unrelated points (as a placebo). The incidence and severity of nausea and vomiting were assessed before the intervention, during the surgery, at recovery room and two hours after the surgery, using visual analog scale (VAS).
Participants/Inclusion and exclusion criteria
Inclusion criteria: No addiction to drugs, sedatives and alcohol in mother, lack of injuries and wounds at the ears, no History of Auriculotherapy, No taking antiemetic or emetic medications or herbal medications during past twenty-four hours and no history of hyperemesis gravidarum. Exclusion criteria: The patient's unwillingness to continue cooperation in research, complications during and after surgery such as excessive bleeding , adhesions, fetal death and prolonged duration of surgery(more than 1 hour), Failure of spinal anesthesia
Intervention groups
In the intervention group, 30 min prior to spinal anesthesia, auriculotherapy (in shenmen, subcortex, kidney and abdominal points) was performed for 20-30 seconds by electrodermal stimulation and auricular seeds fixed on this points. In the placebo group, labels without seeds were attached to unrelated points.
Main outcome variables
بروز و شدت وقوع تهوع و استفراغ

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180526039845N1
Registration date: 2019-06-27, 1398/04/06
Registration timing: retrospective

Last update: 2019-06-27, 1398/04/06
Update count: 0
Registration date
2019-06-27, 1398/04/06
Registrant information
Name
Fatemeh sadat Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3622 2335
Email address
fmousavi@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-09, 1395/02/20
Expected recruitment end date
2017-03-10, 1395/12/20
Actual recruitment start date
2016-07-22, 1395/05/01
Actual recruitment end date
2017-09-11, 1396/06/20
Trial completion date
2017-09-11, 1396/06/20
Scientific title
Study of the effect of Auriculotherapy on nausea and vomiting in women following elective cesarean section
Public title
Effect of Auriculotherapy on nausea and vomiting in women following elective cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having an age range of 18 to 45 years؛ singleton pregnancy and gestational age more than 37 weeks; Labor pains not start, The elective cesarean section planned before the onset of labor, No Medical condition in mother (cardiac, respiratory, hepatic or neurologic); No addiction to drugs, sedatives and alcohol in mother, lack of injuries and wounds at the ears, no history of migraine and no History of Auriculotherapy, using Spinal analgesia for caesarean section, No taking antiemetic or emetic medications or herbal medications during past twenty-four hours and no history of hyperemesis gravidarum.
Exclusion criteria:
The patient's unwillingness to continue cooperation in research, complications during and after surgery such as excessive bleeding , adhesions, fetal death and prolonged duration of surgery(more than 1 hour) Failure of spinal anesthesia
Age
From 18 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were assigned in each group according to block randomization. The size of the blocks was equal to 4.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient didn’t know that she is in the intervention or control(sham) group. Both ears of all subjects of each group were attached with labels, while the labels did not differ in color and appearance. In the intervention group labels with seeds fixed on specific auricular acupuncture points but in control group labels without seeds were attached in sham points; and the subjects were not informed of the main and sham points.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Avenue next to the cinema Hoveizeh- Mashhad Medical Sciences- Department of Science and Technology
City
مشهد
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2016-01-02, 1394/10/12
Ethics committee reference number
IR.MUMS.REC.1394.586

Health conditions studied

1

Description of health condition studied
post cesarean nausea and vomiting
ICD-10 code
O82
ICD-10 code description
Single delivery by caesarean section

Primary outcomes

1

Description
nausea and vomiting
Timepoint
during the surgery, at recovery room
Method of measurement
Nausea visual analogue scale

Secondary outcomes

1

Description
Anxiety
Timepoint
before the intervention and at recovery room
Method of measurement
Anxiety Inventory Spielberger

Intervention groups

1

Description
Intervention group: In the intervention group, 30 min prior to spinal anesthesia, auriculotherapy (in shenmen, subcortex, kidney and abdominal points) was performed for 20-30 seconds by electrodermal stimulation and auricular seeds fixed on this points.
Category
Treatment - Other

2

Description
Control group: In the control group (placebo), labels without seeds were attached to unrelated points
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Omolbanin Hospital
Full name of responsible person
fatemeh sadat mousavi
Street address
Bahjat 16، Bahjat street، Crossroads Zarina،Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
golmakanin@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Department of Research and Technology، Mashhad University of Medical Science،behind of Hoveyzeh cinema،ِِDanesgah stret،Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
golmakanin@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
fatemeh sadat mousavi
Position
Midwifery students
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina street,Danesgah Street ,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
00989137913199
Phone
+98 51 3859 1511
Email
fmousavi@muq.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
nahid golmakani
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina street,Danesgah Street ,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
golmakanin@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
fatemeh sadat mousavi
Position
Midwifery students
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina street,Danesgah Street ,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
fmousavi@muq.ac.ir

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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only final analysis
When the data will become available and for how long
Time to print the article up to a year later
To whom data/document is available
All researchers
Under which criteria data/document could be used
There is no manipulation in the data
From where data/document is obtainable
Send a request by email, if not answered, phone call
What processes are involved for a request to access data/document
The requested time is about a week after the request is sent
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