Comparison of the effect of abdominal massage and acupressure of Hugo point (LI4 region) on colic signs of infancy
Design
Samples will be invited to study as convenience sampling
Settings and conduct
Based on randomized blocking, ABC, BAC, CAB and CBA blocks are divided into three groups of massage and acupressure and control.
In this way, the first person will be in the massage group A and the second person of acupressure B in the third control group C.
Participants/Inclusion and exclusion criteria
The minimum and maximum infant age is 1, 3 months, respectively. The infant has a term of birth. The baby is healthy, has no digestive problems (celiac disease) and no organ failure (no hand). The baby has not received previous medical treatment for colic.
Parents use of other colic treatments during intervention, The inability of the massage and acupressure to be performed correctly by the researcher Unwillingness to continue to work with the researcher.
Having a disease that requires medication.
Intervention groups
Performing abdominal massage in one group and compression points in the other group and massage in the massage group three times a day for four weeks.
Main outcome variables
Reduced pain in the infantile colic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181027041477N1
Registration date:2019-03-19, 1397/12/28
Registration timing:registered_while_recruiting
Last update:2019-03-19, 1397/12/28
Update count:0
Registration date
2019-03-19, 1397/12/28
Registrant information
Name
Khadijeh moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3726 3313
Email address
moghadamkh2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-14, 1397/12/23
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the Effect of Abdominal Massage and Acupressure of Hego point on Infantile Colic Symptoms
Public title
Effect of Abdominal Massage and Acupressure of Hego point on Infantile Colic Symptoms
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Infant 1 to 3 months
Term of birth
Exclusion criteria:
No drug use
The health of mother and Infant
Age
From 1 month old to 3 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
129
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be invited to study as convenience sampling. Based on randomized blocking, ABC, BAC, CAB and CBA blocks are divided into three groups of massage and acupressure and control.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants do not Know that are invited for what group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Mashhad University Of Medical Sciences
Street address
Ebnesina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.087
Health conditions studied
1
Description of health condition studied
Infant colic
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
Reduced Pancreatic Colic Pain
Timepoint
First week, second week, third week, fourth week
Method of measurement
Infant Colik Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: massage sessions will take place three times a day, 2 pm, 7 am and 11 pm for massage for four weeks.
Category
Treatment - Other
2
Description
Intervention group: at the pressure of the Hugo LI4, this back point, between the first and second metacarpal bones, and the pressure of one to two minutes as the color of the skin changes (10 seconds pressure and 20 seconds of rest to two minutes Complete) is done. Acupressure will be performed at three o'clock in the afternoon and night (2 o'clock, 7 o'clock and 11 o'clock).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers Mashhad
Full name of responsible person
Tahereh Sadeghi
Street address
Ebnesina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 2851
Fax
+98 51 3859 7313
Email
sadeghit@mums.ac.ir
Web page address
http://nurse.mums.ac.ir/index.php
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Opposite of Daneshgah street, Ghorishy Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3840 1208
Fax
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Khadijeh Moghadam
Position
Senior Child Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebensina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
moghadamkh2@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebensina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
sadeghit@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Khadijeh Moghadam
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8 , 12 Majde Ave , Majde Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3726 3313
Fax
Email
moghadamkh2@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
article
When the data will become available and for how long
one year
To whom data/document is available
team research
Under which criteria data/document could be used
Does not apply
From where data/document is obtainable
tahereh sadeghi
What processes are involved for a request to access data/document