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Studying the Effect of Massage Therapy on the Pain Caused by Umbilical Venous Catheter in Premature Infants.

Protocol summary

Study aim
Studying the Effect of Massage Therapy on the Pain Caused by Umbilical Venous Catheter in Premature Infants
Design
In this study, 50 Premature Infants who meet the inclusion criteria, are selected. Participants are randomly divided into Intervention Group and Control Group and a code was assigned to each participant to hide the intervention group.
Settings and conduct
After obtaining permission from the University Ethics Committee and submitting a letter of introduction from the School of Nursing and Midwifery of Mashhad Educational Center for Research and Therapy of Ghaem and getting permission from the authorities in the NICU Educational Center for Research and Therapy Ghaem, the data were collected from the NICU of Ghaem hospital. Given the fact that the researcher is employed in this ward, they decided to select this setting for the research.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Premature Infants needing to have an Umbilical Vein Catheter in the NICU. The age between 30-37 weeks. Infants weighing over 1000 grams. The PIPP score is less than 7 before insertion of the Venous Catheter. Exclusion Criteria: Apgar at minute 1 less than 5, and Apgar at minute 5 minutes less than 7. Symptoms of hypoxic-ischemic encephalopathy (HIE). The PIPP score is less than 7 before insertion of the venous catheter.
Intervention groups
After the Infants are stabilized, they are placed on a reanimator under the same conditions (Light, Temperature, Noise), then Massage with the Field Technique is performed for 15 minutes. The Massage time is 15 minutes and includes 3 five minute phases. After completion of Massage, the vital signs and the pain will be measured using PIPP. Then, the Catheter, which is the same for all Infants will be applied under sterile conditions by a Resident who has completed six months of residency. During the insertion of the Venous Catheter, and immediately after it, and 2 and 5 minutes later, the Pain and Vital Signs will be measured using PIPP.
Main outcome variables
The Infans who have received Massage, will experience less pain during the administration of the Venous Catheter.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180116038385N1
Registration date: 2018-03-17, 1396/12/26
Registration timing: prospective

Last update: 2018-03-17, 1396/12/26
Update count: 0
Registration date
2018-03-17, 1396/12/26
Registrant information
Name
fatemeh bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3614 6729
Email address
ramezanze961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the Effect of Massage Therapy on the Pain Caused by Umbilical Venous Catheter in Premature Infants.
Public title
Effect of Massage on Neonates' Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Premature Infants needing a Catheter Umbilical Vein at NICU. The ages of the Infants between 30-37 weeks. Infants weighing over 1000 grams The PIPP score less than 7 before insertion of the Venous Catheter.
Exclusion criteria:
Infants of Addicted Mothers Apgar at minute 1 less than 5, and Apgar at minute 5 minutes less than 7 Symptoms of hypoxic-ischemic encephalopathy (HIE). Use of a sedative for the infant in the past 48 hours
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The Researcher's assistant who controls the symptoms of Infants during a painful procedure, does not know to which group does the Infant belongs. A person who scores the Pain does not know to which group does the Infant belongs.
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
Mashhad School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9188764355
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.MUMS.REC.1390.71

Health conditions studied

1

Description of health condition studied
The subject is not a disease.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Reducing pain in preterm infants
Timepoint
Before massage, before and after insertion of the venous catheter, at least 2, 5 minutes after insertion of the catheter.
Method of measurement
Premature Infant Pain Profile

Secondary outcomes

empty

Intervention groups

1

Description
After the Infants are stabilized, they are placed on a reanimator under the same conditions (Light, Temperature, Noise), then Massage with the Field Technique is performed for 15 minutes. The Massage time is 15 minutes and includes 3 five minute phases. After completion of Massage, the vital signs and the pain will be measured using PIPP. Then, the Catheter, which is the same for all Infants will be applied under sterile conditions by a Resident who has completed six months of residency. During the insertion of the Venous Catheter, and immediately after it, and 2 and 5 minutes later, the Pain and Vital Signs will be measured using PIPP.
Category
Other

2

Description
Control group: All of the treatment steps were identical for the infants in the control group except that they were not given massage.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
NICU, Educational and Research Center Ghaem Hospital in Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Behnam Vashani
Street address
Faculty of Nursing and Midwifery, Avicenna St., Avicenna Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188764355
Phone
+98 51 3614 6729
Email
ramezanze961@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Behnam Andashani
Street address
Faculty of Nursing and Midwifery, Avicenna St., Avicenna Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188764355
Phone
+98 51 3614 6729
Email
ramezanze961@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
Hamid Reza Behnam Vashani
Position
Lecturer, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Avicenna St., Avicenna Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188764355
Phone
+98 51 3614 6729
Email
behnamhr@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Behnam Vashani
Position
Lecturer, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Avicenna St., Avicenna Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
0188764355
Phone
+98 51 3614 6729
Email
behnamhr@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh bagheri
Position
دانشجو
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Avicenna St., Avicenna Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188764355
Phone
+98 51 3614 6729
Email
bagherifatemeh59@yahoo.com

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
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
Undecided - It is not yet known if there will be 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
Title and more details about the data/document
Only part of the information can be shared such as information on the main outcome or the like
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will only be available to researchers working in academic and academic institutions
Under which criteria data/document could be used
Allow data from researchers to be obtained
From where data/document is obtainable
Mashhad University of Medical Sciences, School of Nursing and Midwifery Research Council
What processes are involved for a request to access data/document
Send an application to the Vice-Chancellor of the Nursing and Midwifery Faculty and review it at the Research Council and then agree / disapprove the applicant's request
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