The Effect of Yaxon Touch on Pain Control and Weight gain in Premature Infants Hospitalized in Neonatal Intensive Care Unit
Design
This classical experimental study will be performed on two neonates of Taleghani Hospital in Gonabad, Iran. The infants were divided into two equal groups: the Jackson and the control groups. The researcher will be responsible for weight measurement and pain control.
This study was randomly selected from preterm infants referred to Taleghani Children's Medical Center.
Settings and conduct
This classical experimental study will be performed on two neonates of Taleghani Hospital in Gonabad, Iran. The infants were divided into two equal groups: the Jackson and the control groups.Parents of preterm infants were told that the study was voluntary and that they could exclude their infants at any stage of the study. Touch is the first sensory system to evolve and form the basis of interactions between infants and nurses. Jackson is a traditional Korean touch therapy used to treat and relieve fatigue.
The yaxon protocol has key traditional aspects - including warm hands, gentle non-pressure touch and gentle hand movement - which is suitable for premature infants.In the Jackson touch the non-dominant hand behind the baby and the dominant hand are placed on the baby's chest and abdomen. The Jackson touch is performed by the researcher for 15 minutes once each morning (11-9am) for 5 consecutive days.
Participants/Inclusion and exclusion criteria
Premature infants without congenital defects.
Intervention groups
The intervention in this study is a kind of Jackson touch To evaluate its effectiveness on weight gain and pain control in neonates.Yaxson is a Korean massage.
The control group receives the services routinely.
Main outcome variables
yaxon touch on pain control in preterm infants.
yaxon touch on weight gain in preterm infants.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200130046304N1
Registration date:2020-04-13, 1399/01/25
Registration timing:retrospective
Last update:2020-04-13, 1399/01/25
Update count:0
Registration date
2020-04-13, 1399/01/25
Registrant information
Name
nastaran semnani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3322 3545
Email address
nastaran.semnani45@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-02-18, 1398/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Yaxon Touch on Pain Control and Weight gain in Premature Infants Hospitalized in Neonatal Intensive Care Unit
Public title
The Effect of Yaxon Touch on Pain Control and Weight gain in Premature Infants Hospitalized in Neonatal Intensive Care Unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
- Premature infants 32-37 weeks hospitalized in Taleghani Pediatric Hospital, Gonbad.
- infants not connected to the ventilator.
Children whose legal guardian has given written consent to participate in the study
The baby is not infected with other chronic diseases that the study protocol causes further damage to the baby
Infants over seven days old.
Exclusion criteria:
-Family's willingness to research for whatever reason.
Baby death
Early discharge of the baby
Changes in any general condition of the baby
Need for surgery.
Age
From 7 days old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of chalos University of Medical Sciences
Street address
University Boulevard, Golestan, Aliabad, Iran
City
Ali abad
Province
Golestan
Postal code
49717-83897
Approval date
2019-08-06, 1398/05/15
Ethics committee reference number
IR.IAU.CHALUS.REC.1398.016
Health conditions studied
1
Description of health condition studied
Premature infants
ICD-10 code
p07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
neonatal pain control
Timepoint
5 day
Method of measurement
The tool used in this study to record the information will be a checklist for recording the outcomes of the NIPS pain management questionnaire.
2
Description
Weight gain in newborns
Timepoint
5day
Method of measurement
In both groups, the baby's weight will be measured using the scale-LAIKA- with a measurement accuracy of 5 grams.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Jackson protocol used in this study combines the following procedures: 1. After wearing a clean gauze, your hands and arms will be completely covered with antimicrobial detergents for 3 minutes. Warm up with Warmer to reach 34 degrees Celsius.3-The researcher presses both arms and muscles of both shoulders for one minute to concentrate the vital energy of the palms.4-The researcher touches Jackson Premature baby supplies. Jackson's touch lasts for 15 minutes: 5 minutes of hand rest and 5 minutes of gentle stroking and 5 minutes of rest again. The researcher's fingers will be in constant touch with the baby so that the baby will not feel pressure.1-Hand Rest -5 Minutes: While one hand rests on the chest and abdomen of the preterm infant, the back of the preterm infant is supported with the other, the researcher concentrates energy on her resting hands with deep breaths During this time, the researcher slowly breathed in to keep calm2-gentle stroke (5 minutes): Researcher repeated hand and stroke for 5 minutes in the same position: stroking (1 minute) -setting (30 seconds) -setting (1 minute) -setting (30 seconds) -setting (2 minutes). The abdomen and chest researcher pats the baby clockwise in a circular motion 1 cm in diameter every 10 seconds.3-Resting the hand (5 minutes): The researcher rests the hand as if The above described will follow. The Jackson touch will be performed by the researcher once each morning (11-9am) and for 5 consecutive days
Category
Other
2
Description
Control group: Routine work is done.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Talghani Hospital
Full name of responsible person
Nastaran Semnani
Street address
Street Talghani
City
Gonbad kavos
Province
Golestan
Postal code
49717-83897
Phone
+98 17 3322 3545
Email
nastaran.semnani45@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hojati
Street address
Street Daneshgah
City
Ali Abad
Province
Golestan
Postal code
49717-83897
Phone
+98 17 3322 3545
Email
h_hojjati1362@yahoo.com
Web page address
http://edu.aliabadiau.ac.ir/
Grant name
-
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Azad University of Abad
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Nastaran Semnani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alavi
City
Gonbad
Province
Golestan
Postal code
49717-83897
Phone
+98 17 3322 3545
Fax
Email
nastaran.semnani45@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nastaran Semnani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alavi
City
Gonbad
Province
Golestan
Postal code
49717-83897
Phone
+98 17 3322 3545
Fax
Email
nastaran.semnani45@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nastaran Semnani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Street 7 Alavi
City
Gonbad kavos
Province
Golestan
Postal code
49717-83897
Phone
+98 17 3322 3545
Email
nastaran.semnani45@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
All potential data can be shared after unidentifiable people
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
For further research
From where data/document is obtainable
nastaran.semnani45@gmail.com
What processes are involved for a request to access data/document
By sending an email to the address above. It will be answered within at least one week