Purposes: the purpose of this study is comparing the effect of Hugo point compressive massage with and without ice on the pain resulted from Pentavalent vaccine in Infants. Study design: 72 two-month healthy infants who referred to Fayazbakhs public health center, Gonabad, for vaccination were attributed to three groups of Hugo point massage with ice, Hugo point massage without ice, and control group randomly (24 persons per group). The inclusion criteria are: admitting for vaccination in due time or with one week delay, Infants being in the normal weight and height percentile and no consumption of anti-pain drug the night before vaccination.Exclusion critaria: any kind of problem in vaccination procedure (injection repetition, selecting unsuitable location, injection angle, injection depth, vaccination volume). Method: relative intervention will be performed with each group five minutes before vaccination so that Hugo point of right hand was pressurized for one minute using soft part of the thumb rotationally and in a counter clockwise manner with medium pressure in first test group and/or ice cube covered in plastic glove and one-layer cotton cloth for second test group; the intervention is repeated twice after 30s relaxation. No intervention is performed in control group. Pain level will be measured before and after each intervention. Finally, resulted findings of three groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052127982N1
Registration date:2016-07-02, 1395/04/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Parisa Atayee
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5027
Email address
atayee.p@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Expected recruitment start date
2016-05-29, 1395/03/09
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Hugo point pressure massage with and without ice on pain due to Pentavalent vaccine in infants
Public title
Comparison of the effect of Hugo point pressure massage with and without ice on pain due to vaccination
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Parents should agree on engaging the infant in the study. Infants who attend for the first round of Pentavalent vaccination mostly with one week delay. Infants should be in the normal weight and height percentile when receiving the vaccination. Auxiliary temperature should be between 36.5 and 37.5oC. Infants should be relax before vaccination. There should be no consumption of acetaminophen or any other anti-pain drug the night before vaccination. They should be fed 2-3 hours before vaccination. There should be no problem or insomnia before injection based on descriptions from her/his mother.Exclusion criteria: parents leave the study. Polio drop is given before vaccination. Occurrence of any problem during Pentavalent vaccination (injection repeat, selecting unsuitable location, injection angle, injection depth, wrong selection of the vaccine, vaccine volume), crying and uneasiness 5s before vaccination or after video control
Age
From 2 months old to 2 months old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sampling method: it will be done through convenience sampling and random allocation using permutation blocking method.
Blinding: intervention and control groups include two-month infants who are naturally blind in terms of the intervention target.( MBPS tool is used to measure pain scale based on three criteria of face change, crying and body movements of infants.) Pain scale is measured by someone not aware of the type of intervention. Data are also analyzed by someone not aware of the intervention and control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Postal code
9691793718
Approval date
2016-05-11, 1395/02/22
Ethics committee reference number
IR.GMU.REC.1395.17
Health conditions studied
1
Description of health condition studied
Factors influencing health status and contact with health services
ICD-10 code
Z27.8
ICD-10 code description
Need for immunization against other combinations of infectious diseases
Primary outcomes
1
Description
pain due to vaccination
Timepoint
During 5 second before immunization to 15 second after
Method of measurement
Modified Behavioral Pain Scale (MBPS) in infants
Secondary outcomes
empty
Intervention groups
1
Description
Hugo point of the right hand will be massaged for 1 minute using ice cube covered in plastic glove and one-layer cotton cloth for second test group; the intervention is repeated twice after 30s relaxation
Category
Prevention
2
Description
Infants of the control group will be put on the bed without any intervention and based on the usual procedure of the center.
Category
Prevention
3
Description
Hugo point of the right hand will be massaged for 1 minute using soft part of the thumb in first test group and the intervention will be repeated twice after 30s relaxation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fayazbakhs public health center
Full name of responsible person
Parisa Atayee
Street address
Emam khomeini street, Gonabad
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Gonabad University of Medical Sciences
Full name of responsible person
Doctor Ali Mohammadpour
Street address
Vice chancellor for research,Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
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,Gonabad University of Medical Sciences
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
Gonabad University of Medical Sciences
Full name of responsible person
Parisa Atayee
Position
MSc Student of Public Health Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
atayee.p@gmu.ac.irnemesis.parisa@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Doctor Shahla Khosravan
Position
Faculty member at Gonabad University of Medical Sciences
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Postal code
Phone
+98 51 5722 3028
Fax
Email
khosravan@gmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Parisa Atayee
Position
MSc Student of Public Health Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Postal code
Phone
Fax
Email
Atayee.p@gmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)