Protocol summary

Summary
This research was carried out with the aim of to investigate the trend of NVP treatment before and during using acupressure wristband and satisfaction of users about effectiveness of wristband. Methods: This interventional research was conducted on 50 pregnant women that have NVP symptoms in Ardabil city. Inclusion criteria were having low intensity to mild nausea and vomiting, wanted and normal pregnancy, gestational age under 20 weeks, ability to reading and writing, and filling consent form; exclusion criteria were severe nausea and vomiting of pregnancy symptoms, mole hydatiform pregnancy, twine pregnancy, symptoms of abortion, having any known disease, physiological problems, unpleasant event in past 6 months, consumption of any kind of drug (antiemetic and emetic) and smoking.Participants were used the wristband with the pressure on the p6 point. Frequency, duration, and severity of nausea, and the frequency of vomiting 3 days before using wristband and 3 days during continually using it and two times a day (day and night) were recorded with filling of questionnaires by participants.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138810162437N3
Registration date: 2010-03-06, 1388/12/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-03-06, 1388/12/15
Registrant information
Name
Samira Shahbazzadegan
Name of organization / entity
Ardabil University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 45 3344 5595
Email address
s.shahbazzadegan@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Scineces
Expected recruitment start date
2006-04-17, 1385/01/28
Expected recruitment end date
2006-11-20, 1385/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the Trend of Pregnancy Nausea and Vomiting Treatment Using Acupressure Wristband
Public title
Investigation the Trend of Pregnancy Nausea and Vomiting Treatment Using Acupressure Wristband
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having low intensity to mild nausea and vomiting, wanted and normal pregnancy, gestational age under 20 weeks, ability to reading and writing, and filling informed consent form Exclusion criteria: severe nausea and vomiting of pregnancy symptoms, mole hydatiform pregnancy, twine pregnancy, symptoms of abortion, having any known disease, physiological problems, unpleasant event in past 6 months, consumption of any kind of drug (antiemetic and emetic) and smoking
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil University of Medical Scineces
Street address
Ardabil University of Medical Scineces
City
Ardabil
Postal code
Approval date
2005-11-05, 1384/08/14
Ethics committee reference number
sh/32/3149

Health conditions studied

1

Description of health condition studied
Nausea and vomiting of pregnancy
ICD-10 code
O21.0
ICD-10 code description
Mild hyperemesis gravidarum

Primary outcomes

1

Description
Frequancy of vomiting
Timepoint
Before tretment, eyery 12 hours during intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Acupressure Wrist-band for 3 days, constantly
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Mirzahoseni health centre
Full name of responsible person
Street address
City
Ardebil

2

Recruitment center
Name of recruitment center
Bakeri health centre
Full name of responsible person
Street address
City
Ardebil

3

Recruitment center
Name of recruitment center
Javid Mohseni health centre
Full name of responsible person
Street address
City
Ardebil

4

Recruitment center
Name of recruitment center
Health centre NO. 27
Full name of responsible person
Street address
City
Ardebil

5

Recruitment center
Name of recruitment center
Azadegan health centre
Full name of responsible person
Street address
City
Ardebil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Scineces
Full name of responsible person
Samira Shahbazzadegan
Street address
Ardabil University of Medical Scineces
City
Ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Scineces
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
Ardabil University of Medical Scineces
Full name of responsible person
Samira Shahbazzadegan
Position
Master of Sciences
Other areas of specialty/work
Street address
office of Journal of Ardabil University of Medical Science
City
Ardabil
Postal code
Phone
+98 45 1551 0036
Fax
Email
s.shahbazzadegan@arums.ac.irsamirashahbazzadegan2000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Science
Full name of responsible person
Samira Shahbazzadegan
Position
Master of science
Other areas of specialty/work
Street address
Office of Journal of Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1551 0036
Fax
Email
s.samirashahbazzadegan@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Science
Full name of responsible person
Samira Shahbazzadegan
Position
Master of Sciences
Other areas of specialty/work
Street address
Office of Journal of Ardabil University of Medical Science
City
Ardabil
Postal code
56197
Phone
+98 45 1551 0036
Fax
+98 45 1551 0036
Email
s.shahbazzadegan@arums.ac.irsamiashahbazzadegan2000@yahoo.com
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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