This clinical trial aims to study the effect of acupressure to control nausea in pregnancy as a non-invasive method with least complications and no cost. Nighnty primigravids with gestational age less than 12 weeks suffering from nausea with or without vomiting will enter the study. They will be randomly divided into 3 groups of 30. The experimental group will be treated with acupressure on Neiguan (PC6). The sham group will receive acupressure on a placebo point and the third group will be treated with Vit B6. In the two acupressure groups, acupressure will be done 4 times a day, 10 minutes each time from the second day to the 5th day. If the patient experiences an excessive nausea in pressure intervals, she could perform the next acupressure earlier, but should keep a total of 4 in a day. At the end of each day, nausea and vomiting will be measured by the Rhode index criteria.This assessment will be done as a self-recording of symptoms by mothers in a questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512187265N6
Registration date:2016-03-02, 1394/12/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-02, 1394/12/12
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-12-23, 1394/10/02
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of PC6 (Neiguan) acupressure on the vomiting, Nausea and retching in pregnant women
Public title
Effect of acupressure on pregnancy-induced nausea and vomitting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The First pregnancy; No history of infertility; Singleton pregnancy; No history of Underlying or Concomitant disease
Exclusion criteria: Unwillingness to stay in the study; Proof of fetal death; Concomitant disease; Pregnancy after treatment of infertility; Smoking; History of acupressure; Gastrointestinal or urinary tract infections; Dehydration and Hyperemesis gravidarum; History of mental disorders
Age
From 16 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
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
MUM's central office, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2014-07-20, 1393/04/29
Ethics committee reference number
86722
Health conditions studied
1
Description of health condition studied
nausea and vomiting in pregnancy
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
The frequency, intensity and duration of nausea, vomiting and retching
Timepoint
day 2 and 5
Method of measurement
Evaluation of severity, duration and inconvenience level due to nausea, vomiting and retching according to Rhodes index criteria by questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acupressure on Neiguan
Category
Treatment - Other
2
Description
Control group1:
acupressure on a placebo point
Category
Treatment - Other
3
Description
control group 2:
pharmacotherapy with Vitamin B6
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Danesh Amouz Health Center
Full name of responsible person
Dr. Hoda Azizi
Street address
10 Danesh Amouz, Danesh Amouz Blv, Vakil Abad Blv
City
Mashhad
2
Recruitment center
Name of recruitment center
Vilashahr Health Center
Full name of responsible person
Dr. Hoda Azizi
Street address
Vilashahr Health Center, Vilashahr, Beginning of the road Torghabeh