Protocol summary

Study aim
Determining the effect of ericulotherapy on pain intensity after cesarean section in women referred to Imam Ali Medical Center in Amol
Design
Clinical trial with control group and sham group, with parallel, double-blind, randomized groups, which were randomly selected from the random number table, samples and randomly placed in groups using the output numbers of SPSS software version 19 Will take.
Settings and conduct
The surgical ward of Imam Ali Hospital in Amol is the site of the project. The researcher, with the help of the ward nurse, identifies the women who are on the list of cesarean section and meets and interviews with patients undergoing cesarean section. This study is double-blind and both the patient and the outcome assessor are unaware of the placement of patients in the experimental and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: previous history of cesarean section, gestational age 37-40 weeks, age 18-35 years, similar anesthesia protocol. Exclusion criteria: History of diabetes, hypertension, kidney, liver and cardiovascular diseases, neurological and psychiatric diseases, as well as the use of any special drugs, smoking, alcohol, history of vaginal delivery, history of treatment of ear disease during the last six months.
Intervention groups
In the intervention group, auricular therapy will be applied bilaterally on both ears symmetrically. In the sham group, auriculotherapy will be performed for the group receiving the unreal massage in places other than the locations of the intervention group.
Main outcome variables
in the patient is the Visual Adjustment Scale (VAS), to assess pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130822014436N1
Registration date: 2020-11-24, 1399/09/04
Registration timing: registered_while_recruiting

Last update: 2020-11-24, 1399/09/04
Update count: 0
Registration date
2020-11-24, 1399/09/04
Registrant information
Name
Amir Emami Zeydi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
a.emami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-31, 1399/05/10
Expected recruitment end date
2021-01-29, 1399/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of auriculotherapy on postoperative pain intensity after cesarean section
Public title
The effect of uriculotherapy on pain after cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Previous history of cesarean section, Gestational age 37-40 weeks age 18-35 years Similar anesthesia protocol
Exclusion criteria:
History of diabetes High blood pressure Kidney, liver and cardiovascular diseases, neurological diseases Consumption of any medicine, cigarettes, alcohol Vaginal delivery history History of ear disease treatment during the last six months
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
For simple random sampling, individuals are divided into intervention and control groups using a random number table if they have inclusion criteria and availability.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind, so that both the patient and the person evaluating the outcomes using the VAS tool were unaware of the placement of patients in the experimental and control groups, so the subjects and colleagues asked about the division. They will not be aware of the classification of the subjects and the relevant measures.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Sari, Imam Square, Joybar Three Ways, beginning of Vali-e-Asr Highway, Mazandaran University of Medical Sciences
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Approval date
2020-07-15, 1399/04/25
Ethics committee reference number
IR.MAZUMS..REC.1399.7708

Health conditions studied

1

Description of health condition studied
Pain after cesarean section
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
Visual Analogue Scale(VAS)
Timepoint
Pain intensity will be measured and recorded at times (15-30-60 minutes) and (3-6-12-24 hours) after the intervention.
Method of measurement
the patient is the Visual Adjustment Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A group that will be applied to Shen Men, Points Zero, pelvic, pelvis, abdomen, endocrine, uterus bilaterally on both ears symmetrically, auricular therapy.
Category
Treatment - Surgery

2

Description
Control group: In this group, auricular therapy will be performed in places other than the intervention group without pressure.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital in Amol
Full name of responsible person
Zohre Hosseini
Street address
Nor road
City
Amol
Province
Mazandaran
Postal code
46171 41497
Phone
+98 11 4426 4661
Email
b.ghasemi@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Joibar three ways, at the beginning of Vali-e-Asr highway
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱۴۸۱۵۷
Phone
+98 11 3304 4030
Email
ict@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Amir Emami Zeydi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Amir Mazandarani Blvd. - Vesal St. - Nasibeh School of Nursing and Midwifery
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
0098 11 33367342-4
Email
emamizeydi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amir Emami Zeydi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh Nursing and Midwifery School, Vesal Street, Amir Mazandarani Boulevard, Sari, Mazandaran Province, Iran.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3336 7342
Fax
+98 11 3326 8915
Email
a.emami@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amir Emami Zeydi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh Nursing and Midwifery School, Vesal Street, Amir Mazandarani Boulevard, Sari, Mazandaran Province, Iran.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
+98 11 3336 7342
Fax
+98 11 3326 8915
Email
a.emami@mazums.ac.ir

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
Loading...