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Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk Neonates (YTKS)

Primary Purpose

Preterm Infants, Infant, Low Birth Weight

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Yakson touch
Conventional handling
Kinesthetic stimulation
Kangaroo Mother Care
Sponsored by
Asir John Samuel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Infants focused on measuring Neonates, physical therapy, neonatal intensive care units, yakson touch, kinesthetic stimulation

Eligibility Criteria

1 Day - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neonates with birth weight less than 2500 grams and born before 37 weeks of gestation males and females will be recruited in the study

Exclusion Criteria:

  • Medically unstable neonates or neonates with communicable disease or congenital anomaly or skin infection will be excluded from the study

Sites / Locations

  • Preeti Parashar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yakson touch and Kinesthetic stimulation

Conventional Handling and KMC

Arm Description

Yakson touch (YT) The therapist will relax arms and shoulder muscles for 1 minute and will do deep breathing to accumulate Ki energy on the palms. The Therapist will apply Yakson on the neonate. Kinesthetic stimulation (KS) For giving kinesthetic stimulation the neonate will be placed in supine position. There will be six passive flexion and extension movements. Each of the movement will each last for approximately 10 seconds. The movements will be performed in the following order -right arm, left arm, right leg, left leg, both legs simultaneously

Conventional Handling (CH) The neonates in control group will receive developmental positioning(positioning of preterm infants for optimal physiological development) for 20 minutes per hour for 5 days. Kangaroo mother care (KMC) Holding the neonate skin to skin by mother for one hour a day

Outcomes

Primary Outcome Measures

Change in Neonatal behavioral assessment scale (NBAS)
Neonatal behavioral assessment scale (NBAS) will be used to monitor the effects of Yakson touch and kinesthetic stimulation on the development of high risk neonates. Baseline reading of NBAS will be recorded for the neonates in control and experimental groups before the beginning of intervention. The NBAS contains 28 behavioural items, 18 reflex items, and 7 supplementary items for fragile or high-risk infants. It is a neurobehavioural screening tool

Secondary Outcome Measures

Heart rate
Recorded pre and post intervention for each session
Respiratory rate
Recorded pre and post intervention for each session
Systolic Blood Pressure
Recorded pre and post intervention for each session
Saturation of inhaled oxygen
Recorded pre and post intervention for each session

Full Information

First Posted
June 21, 2016
Last Updated
August 14, 2018
Sponsor
Asir John Samuel
Collaborators
Maharishi Markendeswar University (Deemed to be University)
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1. Study Identification

Unique Protocol Identification Number
NCT02815904
Brief Title
Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk Neonates
Acronym
YTKS
Official Title
Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk neonates-a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asir John Samuel
Collaborators
Maharishi Markendeswar University (Deemed to be University)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The role of physiotherapy interventions in treatment of high risk infants has not been established even after a number of studies. The high risk infants are prone to developmental delays and early intervention is most effective for them owing to the plasticity of brain in early infancy. Yakson is one among the most effective and safe methods of tactile stimulation for preterm neonates. Tactile and kinesthetic stimulation techniques have been proved to be effective but there is no standardized protocol. The present study will try to investigate the efficacy of Yakson touch in combination with kinesthetic stimulation on the development of high risk neonates against conventional handling which will include developmental positioning and Kangaroo mother care.
Detailed Description
Yakson touch Universal precautions to maintain sterile conditions will be taken. Then the therapist will warm both hands with a radiant warmer so that the temperature of the palms reaches between 93F and 94F (33.9-34.4°C). Digital thermometer will be used to check the temperature of palms. The therapist will relax arms and shoulder muscles for 1 minute and will do deep breathing to accumulate Ki energy on the palms. The Therapist will apply Yakson on the neonate. Yakson will be given for 15 minutes which will be divided into resting the hands, caressing gently, and again resting the hands, each of which will last for 5 minutes. Throughout the application of Yakson, fingers and palm of the therapist will be in constant contact and the contact will be such that there is no pressure on the infant. Resting the hands for 5 minutes- While one hand is resting on the chest and abdomen of the neonate and other hand is supporting the back, the therapist will concentrate on resting hands assuming that a healthy Ki energy is passing to the neonate. During this therapist will do slow breathing to remain relaxed. Caressing gently for 5 minutes-With hand in same position, the therapist will caress repeatedly for 5 minutes. Therapist will caress for 1 minute, rest for 30 seconds, caress for 1 minute, rest for 30 seconds and caress for 2 minutes. The therapist will caress the abdomen and chest of the infant in clockwise direction in a diameter of 1 centimeter in circular motion every 10 seconds Resting the hands for 5 minutes- The therapist will rest the hands as previously described. (* The therapist will caress repeatedly for 5 minutes. Therapist will caress for 1 minute, rest for 30 seconds, caress for 1 minute, rest for 30 seconds and caress for 2 minutes. The therapist will caress the abdomen and chest of the infant in clockwise direction in a diameter of 1 centimeter in circular motion every 10 seconds.) Kinesthetic stimulation For giving kinesthetic stimulation the infant will be placed in supine position. There will be six passive flexion and extension movements. Each of the movement will each last for approximately 10 seconds. The movements will be performed in the following order -right arm, left arm, right leg, left leg, both legs simultaneously Control group treatment The neonates in control group will receive Kangaroo mother care (holding the neonate skin to skin by mother) for one hour a day and developmental positioning(positioning of preterm infants for optimal physiological development) for 20 minutes per hour for 5 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants, Infant, Low Birth Weight
Keywords
Neonates, physical therapy, neonatal intensive care units, yakson touch, kinesthetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yakson touch and Kinesthetic stimulation
Arm Type
Experimental
Arm Description
Yakson touch (YT) The therapist will relax arms and shoulder muscles for 1 minute and will do deep breathing to accumulate Ki energy on the palms. The Therapist will apply Yakson on the neonate. Kinesthetic stimulation (KS) For giving kinesthetic stimulation the neonate will be placed in supine position. There will be six passive flexion and extension movements. Each of the movement will each last for approximately 10 seconds. The movements will be performed in the following order -right arm, left arm, right leg, left leg, both legs simultaneously
Arm Title
Conventional Handling and KMC
Arm Type
Active Comparator
Arm Description
Conventional Handling (CH) The neonates in control group will receive developmental positioning(positioning of preterm infants for optimal physiological development) for 20 minutes per hour for 5 days. Kangaroo mother care (KMC) Holding the neonate skin to skin by mother for one hour a day
Intervention Type
Other
Intervention Name(s)
Yakson touch
Other Intervention Name(s)
YT
Intervention Description
Yakson is a Korean therapeutic touch given to neonates and infants by caressing their abdomen with one hand while the other hand is placed on the back of the neonate\infant to relieve their pain or to calm them down.
Intervention Type
Other
Intervention Name(s)
Conventional handling
Other Intervention Name(s)
CH
Intervention Description
Positioning of preterm infants for optimal physiological development
Intervention Type
Other
Intervention Name(s)
Kinesthetic stimulation
Other Intervention Name(s)
KS
Intervention Description
For kinesthetic stimulation, all the limbs were given six passive flexion and extension movements
Intervention Type
Other
Intervention Name(s)
Kangaroo Mother Care
Other Intervention Name(s)
KMC
Intervention Description
Providing skin to skin human touch
Primary Outcome Measure Information:
Title
Change in Neonatal behavioral assessment scale (NBAS)
Description
Neonatal behavioral assessment scale (NBAS) will be used to monitor the effects of Yakson touch and kinesthetic stimulation on the development of high risk neonates. Baseline reading of NBAS will be recorded for the neonates in control and experimental groups before the beginning of intervention. The NBAS contains 28 behavioural items, 18 reflex items, and 7 supplementary items for fragile or high-risk infants. It is a neurobehavioural screening tool
Time Frame
Change from Baseline Neonatal behavioral assessment scale at 1 week
Secondary Outcome Measure Information:
Title
Heart rate
Description
Recorded pre and post intervention for each session
Time Frame
up to 1 week
Title
Respiratory rate
Description
Recorded pre and post intervention for each session
Time Frame
up to 1 week
Title
Systolic Blood Pressure
Description
Recorded pre and post intervention for each session
Time Frame
up to 1 week
Title
Saturation of inhaled oxygen
Description
Recorded pre and post intervention for each session
Time Frame
up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neonates with birth weight less than 2500 grams and born before 37 weeks of gestation males and females will be recruited in the study Exclusion Criteria: Medically unstable neonates or neonates with communicable disease or congenital anomaly or skin infection will be excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preeti Parashar, BPT
Organizational Affiliation
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Maharishi Markandeshwar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Preeti Parashar
City
Ambāla
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Parashar P, Samuel AJ, Aranha VP. Efficacy of early Yakson touch and kinaesthetic stimulation (YAKIN) on the development of high risk neonates: A randomized controlled trial protocol. J Nepal Paediatr Soc 2017;37(2):173-9.
IPD Sharing Time Frame
Published in, Journal of Nepal Paediatric Society
IPD Sharing Access Criteria
Full-text available free at the journal site
IPD Sharing URL
http://dx.doi.org/10.3126/jnps.v37i2.16724
Citations:
PubMed Identifier
22792482
Citation
Bahman Bijari B, Iranmanesh S, Eshghi F, Baneshi MR. Gentle Human Touch and Yakson: The Effect on Preterm's Behavioral Reactions. ISRN Nurs. 2012;2012:750363. doi: 10.5402/2012/750363. Epub 2012 Jun 25.
Results Reference
background
PubMed Identifier
21975752
Citation
Pillai Riddell RR, Racine NM, Turcotte K, Uman LS, Horton RE, Din Osmun L, Ahola Kohut S, Hillgrove Stuart J, Stevens B, Gerwitz-Stern A. Non-pharmacological management of infant and young child procedural pain. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD006275. doi: 10.1002/14651858.CD006275.pub2.
Results Reference
background
PubMed Identifier
17962243
Citation
Im H, Kim E, Park E, Sung K, Oh W. Pain reduction of heel stick in neonates: Yakson compared to non-nutritive sucking. J Trop Pediatr. 2008 Feb;54(1):31-5. doi: 10.1093/tropej/fmm083. Epub 2007 Oct 25.
Results Reference
background
PubMed Identifier
18353332
Citation
Im H, Kim E. Effect of Yakson and Gentle Human Touch versus usual care on urine stress hormones and behaviors in preterm infants: a quasi-experimental study. Int J Nurs Stud. 2009 Apr;46(4):450-8. doi: 10.1016/j.ijnurstu.2008.01.009. Epub 2008 Mar 18.
Results Reference
background
PubMed Identifier
19713405
Citation
Im H, Kim E, Cain KC. Acute effects of Yakson and Gentle Human Touch on the behavioral state of preterm infants. J Child Health Care. 2009 Sep;13(3):212-26. doi: 10.1177/1367493509337441.
Results Reference
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Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk Neonates

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