A comparison of the effect of pressure on the KID21( Youmen) and P6 (Neiguan) points on the severity of nausea and vomiting pregnancy
Design
A total of 80 pregnant women with nausea and vomiting are selected and, using a block randomization method, assigned into intervention KID21and P6 groups.VAS is used to measure the intensity of nausea and vomiting during the 4 days of intervention.
Settings and conduct
80 pregnant women with nausea and vomiting were selected and, used a block randomization method, assigned into two interventions groups. Visual Analogue Scale (VAS) is used to measure the intensity of nausea and vomiting during the 4 days of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18-35; single pregnancy; first trimester of pregnancy; the presence of moderate to severe nausea and vomiting; the Normal electrolyte; willing to participate.
Exclusion criteria: unwanted pregnancy; gastrointestinal diseases; cigarette smoking; the presence of ketonuria.
Intervention groups
Intervention group 1: Pressure on Kid21 (acupressure) that is 6 Cun ( the width of the first knuckle of the thumb or the width of the second knuckle of the middle finger) above the navel and 0.5 Cun both sides of the midline is symmetrical.
Intervention group 2: Pressure on P6 (acupressure) that is 3 Cun above the China wrist between the two tendons on the palm of the hand above the long palmar and bending radius
Main outcome variables
Description
Nausea and vomiting
Daily Time point
Method of measurement
Visual Analogue Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180206038637N1
Registration date:2018-02-17, 1396/11/28
Registration timing:registered_while_recruiting
Last update:2018-02-17, 1396/11/28
Update count:0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Mojgan naeimirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8301
Email address
m.naeimirad@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of pressure on the KID21( Youmen) and P6 (Neiguan) points on the severity of nausea and vomiting pregnancy
Public title
Evaluation of acupressure on nausea and vomiting of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-35
single pregnancy
first trimester of pregnancy
presence of moderate to severe nausea and vomiting
Normal electrolyte
willing to participate
Exclusion criteria:
unwanted pregnancy
gastrointestinal diseases
cigarette smoking
presence of ketonuria
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 80 pregnant women with nausea and vomiting were selected and, usined a block randomization method, assigned into two intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The Patient is not aware of the control and Case group
Placebo
Not used
Assignment
Parallel
Other design features
Acupressure is preferred over drug therapy for treating NVP (1). The most effective and practical point in acupressure for treating nausea and vomiting is Neiguan P6. This point is approximately three finger breadths (4 cm) above the first transverse crease on the hand wrist between the flexor carpi radials tendons. P6 stimulation has been reported to reduce NVP in many controlled clinical trials (2).Another point used to treat NVP based on scientific resources is KID21 or Youmen or the Hidden Gate. It is 6 Cun above the navel and 0.5 Cun symmetrically from the sides of the middle line of the abdomen. Simulating this point helps improve NVP. In controlled clinical trials, the stimulation of KID21 has reduced NVP (3).Acupressure is preferred over drug therapy for treating NVP (1). The most effective and practical point in acupressure for treating nausea and vomiting is Neiguan P6. This point is approximately three finger breadths (4 cm) above the first transverse crease on the hand wrist between the flexor carpi radials tendons. P6 stimulation has been reported to reduce NVP in many controlled clinical trials (2).Another point used to treat NVP based on scientific resources is KID21 or Youmen or the Hidden Gate. It is 6 Cun above the navel and 0.5 Cun symmetrically from the sides of the middle line of the abdomen. Simulating this point helps improve NVP. In controlled clinical trials, the stimulation of KID21 has reduced NVP (3).1. Nguyen P, Einarson A. Managing nausea and vomiting of pregnancy with pharmacological and nonpharmacological treatments. Women's health (London, England). 2006; 2(5):753-60.2. Lee EJ, Frazier SK. The efficacy of acupressure for symptom management: a systematic review. Journal of pain and symptom management. 2011; 42(4):589-603.3. Naeimi Rad M, Lamyian M, Heshmat R, Jaafarabadi MA, Yazdani S. A Randomized Clinical Trial of the Efficacy of KID21 Point (Youmen) Acupressure on Nausea and Vomiting of Pregnancy. Iran Red Crescent Med J. 2012;14 (11):697-701.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق پزشکی علوم پزشکی بابل
Street address
Babol Univercity of Medical Sciences,Ganjafrooz street
City
Babol
Province
Mazandaran
Postal code
45745-47176
Approval date
2018-01-20, 1396/10/30
Ethics committee reference number
MUBABOL.HRI.REC.1396.145
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting in Pregnancy
ICD-10 code
O21
ICD-10 code description
Excessive vomiting in pregnancy
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Daily
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Pressure on Kid21 (acupressure) that is 6 Cun above the navel and 0.5 Cun both sides of the midline is symmetrical.
Category
Treatment - Other
2
Description
Intervention group 2: Pressure on P6 (acupressure) that is 3 Cun above the China wrist between the two tendons on the palm of the hand above the long palmar and bending radius
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani hospital
Full name of responsible person
mojgan NaeimiRad
Street address
Babol university Of medical seinces, University square , Babol
City
babol
Province
Mazandaran
Postal code
45745-47176
Phone
+98 11 3223 8301
Email
mojy_rad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mojgan Naeimirad
Street address
Babol university Of medical seinces, University square , Babol
City
babol
Province
Mazandaran
Postal code
45745-47176
Phone
+98 11 3223 8301
Email
mojy_rad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mina
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Babol university Of medical seinces, University square , Babol
City
babol
Province
Mazandaran
Postal code
45745-47176
Phone
+98 11 3223 8301
Email
galeshi_m@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mina
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Babol university Of medical seinces, University square , Babol
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3223 8301
Email
galeshi_m@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mina
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Babol university Of medical seinces, University square , Babol
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3223 8301
Email
galeshi_m@yahoo.com
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 more information
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
No - There is not 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