Protocol summary
-
Study aim
-
to evaluate the effect of auriculotherapy on nausea and vomiting during pregnancy.
-
Design
-
This study is a double blind randomized controlled clinical trial with parallel groups. sample of 64 individuals for each group was suggested accordingly
-
Settings and conduct
-
The research setting was the prenatal center of Arash Women’s Hospital affiliated to Tehran University of Medical Sciences. patient and a statistics expert was blind.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria include mild to moderate nausea and vomiting according to Rhodes’ Standard Index; women of 18 to 35 years old; in the 6th to 16th week of pregnancy based on the first day of last menstrual period or sonography; single pregnancy; and literacy.
While exclusion criteria include severe nausea and vomiting; hyperemesis gravidarum during pregnancy; other symptoms such as diarrhea indicating pathologic nature of nausea and vomiting; and any other disease that causes or aggravates the symptoms of nausea and vomiting and results in abortion.
-
Intervention groups
-
the intervention started from day 3 and continued until day 6. On day 3, the researcher, at first, cleaned both outer auricles using 75% alcohol and then the effective areas in controlling nausea and vomiting such as Point zero, stomach, Sympathetic Autonomic, Shen Men, and cardia were determined and the researcher placed a magnetic seed on each point and adhered the seeds using non-latex glue. The participants were then instructed by the researcher to press each spot three times a day (morning, noon, and night) and each time for at least 30 seconds. The same was true for the participants in the sham control group except that the points where these magnetic seeds were placed (e.g. the vision, knee, shoulder and eyes) had no effects on the nausea and vomiting.
-
Main outcome variables
-
nausea and vomiting in pregnancy
General information
-
Reason for update
-
Closure of the study, the need for some modifications such as changing the study setting and blindness and also changing the name of the hospital
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2015061415649N3
Registration date:
2015-08-19, 1394/05/28
Registration timing:
prospective
Last update:
2020-01-29, 1398/11/09
Update count:
1
-
Registration date
-
2015-08-19, 1394/05/28
-
Registrant information
-
-
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
-
2017-12-01, 1396/09/10
-
Actual recruitment end date
-
2018-10-01, 1397/07/09
-
Trial completion date
-
2019-02-19, 1397/11/30
-
Scientific title
-
Determining the effect of auricular acupressure on severity of nausea and vomiting in pregnancy among pregnant women referred to prenatal center of Arash 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 according to Rhodes’ Standard Index
the 6th to 16th week of pregnancy based on the first day of last menstrual period or sonography
single pregnancy
Exclusion criteria:
-
Age
-
From 18 years old to 35 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Data analyser
-
Sample size
-
Target sample size:
128
Actual sample size reached:
128
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomized block design with the size of 4 was used for randomization. The random sequence was proposed by a statistical expert and through appropriate software. A total number of 32 blocks of four were prepared and then the samples were assigned to intervention and sham control groups
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
In order to observe the double-blindness of the study, sham points were used for patients in the sham control group so that individuals were unaware of which group they were assigned to. In addition, the statistics expert was unaware of the fact that which group was real and which were sham. Even those who were in charge of evaluation of the outcomes of the study were also unaware of the assigning of the individuals to real groups
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
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
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
1
-
Sponsor
-
-
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
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
No decision has been made by the team at this time.
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available