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

Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk neonates-a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infants; Infant, Low Birth Weight
• Intervention / Treatment: Other: Yakson touch; Other: Kinesthetic stimulation; Other: Conventional handling; Other: Kangaroo Mother Care

Detailed Description

Yakson touch

1. Universal precautions to maintain sterile conditions will be taken.
2. 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.
3. The therapist will relax arms and shoulder muscles for 1 minute and will do deep breathing to accumulate Ki energy on the palms.
4. 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.
5. 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.
6. 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
7. 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Ambāla, Haryana, India, 133207
      • Preeti Parashar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yakson touch and Kinesthetic stimulation; 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	Other: Yakson touch; 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.; Other Names: YT; Other: Kinesthetic stimulation; For kinesthetic stimulation, all the limbs were given six passive flexion and extension movements; Other Names: KS
Active Comparator: Conventional Handling and KMC; 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	Other: Conventional handling; Positioning of preterm infants for optimal physiological development; Other Names: CH; Other: Kangaroo Mother Care; Providing skin to skin human touch; Other Names: KMC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from Baseline Neonatal behavioral assessment scale at 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Recorded pre and post intervention for each session	up to 1 week
Respiratory rate	Recorded pre and post intervention for each session	up to 1 week
Systolic Blood Pressure	Recorded pre and post intervention for each session	up to 1 week
Saturation of inhaled oxygen	Recorded pre and post intervention for each session	up to 1 week

Collaborators and Investigators

• Sponsor: Asir John Samuel
• Collaborators: Maharishi Markendeswar University (Deemed to be University)
• Investigators: Principal Investigator: Preeti Parashar, BPT, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Maharishi Markandeshwar University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: physical therapy; Neonates; neonatal intensive care units; yakson touch; kinesthetic stimulation
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: MMU/IEC/2016/751; U1111-1184-4324 (Other Identifier: Universal Trial Number (UTN)); 2016-002659-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Study Protocol