Determining the effect of auricular acupressure on severity of nausea and vomiting in pregnancy among pregnant women referred to prenatal center of Mirza kuchak khan Hospital
The study is a single-blind randomized clinical trial to evaluate the effect of acupressure on nausea and vomiting of pregnant women. The study included pregnant women who referred to health care centers at Tehran. 128 eligible pregnant women who complain of nausea and vomiting related to pregnancy. Will be allocated randomly in two groups: intervention and control. The subjects won’t receive any intervention at the first two days after initial of the study and the intervention will be done between third to sixth day after initial of the study.in the intervention group, the magnetic seeds with a special adhesive latex will be attached in five effective points of ears for controlling the nausea and vomiting. Then patient will be asked for making pressure on each points for at least 30 seconds, three times a day.in the control group will be acted the same, but non effective points on nausea and vomiting will be used. Both groups will be asked for completing Rhodes questionnaire for evaluating nausea and vomiting every night for six days. Rhodez questionnaire for evaluation of nausea and vomiting on a daily basis and will be completed in six days for both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061415649N3
Registration date:2015-08-19, 1394/05/28
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-08-19, 1394/05/28
Registrant information
Name
Mohammad Eghbali
Name of organization / entity
Torbat Heydariyeh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5242 1257
Email address
m-eghbali@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of auricular acupressure on severity of nausea and vomiting in pregnancy among pregnant women referred to prenatal center of Mirza kuchak khan Hospital
Public title
The effect of auricular acupressure on nausea and vomiting among pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: mild to moderate nausea and vomiting related to pregnancy based on the Rhodes Index; women aged 18-35; gestational age range between 6-16 weeks based on the first day of the last menstrual period or ultrasonography; single pregnancy with normal fetus; to be able read and write in persian.
Exclusion criteria: to have severe nausea and vomiting and need to use medication other than prescripted drugs or hospitalization; hyperemesis gravidarum.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Science
Street address
Sixth Floor, Central Organization of University, Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2015-06-25, 1394/04/04
Ethics committee reference number
IR.TUMS.REC.1394.278
Health conditions studied
1
Description of health condition studied
Nausea & vomiting in pregnancy
ICD-10 code
O21.9
ICD-10 code description
تهوع و استفراغ بارداری
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Every night for 6 days
Method of measurement
Rhodes index
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, the magnetic seeds with a special adhesive latex will be attached in five effective points of ears for controlling the nausea and vomiting. Then patient will be asked for making pressure on each points for at least 30 seconds, three times a day
Category
Treatment - Other
2
Description
in the control group will be acted the same, but non effective points on nausea and vomiting will be used
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Prenatal center of Mirza Kuchak Khan Hospital
Full name of responsible person
Mohamad Eghbali
Street address
First floor, Mirza Kuchak Khan Hospital, Ostad Nejatollahi St, Area 6, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Doctor Masood Younesian - Vice President of Research and Technology
Street address
Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods St, Keshavarz St, Tehran
City
Tehran
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, Tehran 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohamad Eghbali
Position
PhD Student in nursing
Other areas of specialty/work
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Postal code
1985713834
Phone
+98 22180083
Fax
Email
eghbali.msn@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Reza Negarandeh
Position
PhD in nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Nosrat St., Tohid Sq
City
Tehran
Postal code
Phone
+98 66421685
Fax
Email
rnegarandeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohamad Eghbali
Position
PhD Student in nursing
Other areas of specialty/work
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Postal code
Phone
00
Fax
Email
eghbali.msn@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)